Cardiovascular Risk Factor
Conditions
Keywords
xylitol, erythritol
Brief summary
The principal goal for the study is to examine whether ingestion of a beverage containing artificial sweeteners alters in vitro platelet aggregation. Because of the increasing number of cardiometabolic diseases, such as diabetes mellitus, in the population, the use of artificial sweeteners to replace free sugars has been gaining popularity. Two popular artificial sweeteners are erythritol and xylitol. Erythritol and xylitol are both naturally occurring polyols found in fruits and vegetables. They are potent artificial sweeteners with a higher sweetening intensity and lower calorie content than table sugar. Previous research has shown that the higher levels of sugar alcohols, like those used as artificial sweeteners, in the blood are related to a higher risk of cardiovascular complications, like heart attacks and strokes, and death. This may be because higher levels of sugar alcohols in one's blood may increase the activity of platelets, which would then increase the risk of heart attack and stroke. The investigators therefore want to find if consuming a single beverage that contains an artificial sweetener can raise the levels of sugar alcohols in the blood and if it can alter platelet function or aggregation.
Detailed description
The purpose of this study is to examine if drinking a single beverage that contains an artificial sweetener can perceptibly alter the activity of platelets in the body. Platelets are a component of blood that are primarily responsible for helping to stop bleeding and repair damaged blood vessels by grouping together, a process known as aggregation, to form clots. Artificial sweeteners are popular because they have a lower calorie content than table sugar while still making food and beverages sweet. Their use as a sugar substitute is especially attractive for people with heart disease or diabetes, or for people who are trying to lose weight. Two popular artificial sweeteners are erythritol and xylitol. Erythritol and xylitol are both naturally occurring polyols, also called sugar alcohols, found in fruits and vegetables. They are potent artificial sweeteners with a higher sweetening intensity and lower calorie content than table sugar.This makes them attractive for the use as sugar substitutes or alternatives, particularly for patients with type 2 diabetes. Up to now, there is no prospective data available about polyols with respect to their impact on event outcomes in cardiovascular patients, despite their extensive use in the food industry. Moreover, little is known about plasma levels and metabolic changes following food intake of artificial sweeteners, in particular polyols. The investigators have previously measured fasting levels of various polyols in a large clinical cohort of cardiovascular patients and found that some candidate polyols are related to a higher risk of cardiovascular complications and death. In vitro data using human platelets revealed that the polyols xylitol and erythritol at the levels observed in fasting patients induce platelet aggregation potential. The investigator's data shows that erythritol and xylitol impact platelet function and may, therefore, contribute to cardiovascular mortality. In preliminary studies the investigators found that when ingesting either erythritol or xylitol, the levels of these sweeteners in the plasma rise within the first hour after consumption. With this study the investigators wish to examine whether the postprandial levels are capable of altering platelet function in vitro. The investigators hypothesize that postprandial polyol concentrations following ingestion increase platelet aggregation in the blood.
Interventions
DIETARY_SUPPLEMENTxylitol, 30g
Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose.
DIETARY_SUPPLEMENTerythritol, 30g
Intervention is a drink consisting of 300mL of water containing 30g of erythritol as a single oral dose.
DIETARY_SUPPLEMENTxylitol, 5g
Intervention is a drink consisting of 300mL of water containing 5g of xylitol as a single oral dose.
DIETARY_SUPPLEMENTglucose, 30g
Intervention is a drink consisting of 300mL of water containing 30g of glucose (dextrose) as a single oral dose.
Sponsors
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Cohort 1 Inclusion Criteria: * Age 18 years or above. * Willing and able to sign the consent form. Cohort 1
Exclusion criteria
* Use of anti-platelet medications within 14 days of study enrollment. * Active infection or received antibiotics within 1 month of study enrollment. * Use of over-the-counter probiotic within 1 month of study enrollment. * Diabetes mellitus * Ulcerative colitis, Crohn's disease, or other chronic gastrointestinal disorder. * Past history of bariatric procedures or surgeries (e.g. gastric banding or bypass). * Pregnancy. * Significant chronic illness. Cohort 2 Inclusion Criteria: * Men and women age 18 years or above. * Able to provide informed consent and comply with study protocol. * Diabetes Mellitus Type II Cohort 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet Aggregation After Polyol Ingestion | 30 minutes | Measuring platelet function 30 minutes after polyol ingestion, using established in vitro platelet assays. Platelet aggregation responses, based on changes in light transmission after adding different concentrations of the agonists ADP and TRAP6 are reported. A higher percentage of light transmission indicates an increased aggregation response, with maximum amplitude (100%) indicating total aggregation. |
| Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | Baseline and 30 minutes post ingestion of polyol intervention | Measuring changes in platelet function before versus after xylitol or erythritol ingestion, using established in vitro platelet assays. Platelet aggregation responses, based on changes in light transmission after adding different concentrations of the agonists ADP and TRAP6 are reported. A higher percentage of light transmission indicates an increased aggregation response, with maximum amplitude (100%) indicating total aggregation. |
| Plasma Polyol Levels After Polyol Ingestion | 30 minutes | Measuring plasma levels (uM) of polyols (xylitol or erythritol) 30 minutes after xylitol or erythritol ingestion, using established techniques by mass spectrometry. Xylitol was measured, and is reported below, in the two xylitol intervention arms and erythritol was measured, and is reported below, in the erythritol and glucose intervention arms. |
| Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion | Baseline and 30 minutes post ingestion of polyol intervention | Measuring changes in levels of plasma polyols before versus after xylitol or erythritol ingestion, using established techniques by mass spectrometry. Xylitol concentrations are reported in the two xylitol intervention arms. Erythritol concentrations are reported in the erythritol and glucose intervention arms. |
| Urinary Polyol Levels After Polyol Ingestion | 30 minutes | Measuring the urinary levels of polyols (xylitol or erythritol) 30 minutes after xylitol or erythritol ingestion, using established techniques by mass spectrometry. Xylitol was measured, and is reported below, in the two xylitol intervention arms and erythritol was measured, and is reported below, in the erythritol and glucose intervention arms. |
| Change From Baseline in Urinary Polyol Levels at 30 Minutes Post Polyol Ingestion | Baseline and 30 minutes post ingestion of polyol intervention | Measuring changes in levels of urinary polyols before versus after xylitol or erythritol ingestion, using established techniques by mass spectrometry. Xylitol was measured, and is reported below, in the two xylitol intervention arms and erythritol was measured, and is reported below, in the erythritol and glucose intervention arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | Baseline and 1 day post ingestion of polyol intervention | Measuring changes in lipid levels as markers of changes in metabolism before versus after xylitol or erythritol ingestion. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWilson Tang, MD
The Cleveland Clinic
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Xylitol, 30g oral xylitol, a potent artificial sweetener
xylitol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose. | 10 |
| Erythritol, 30g oral erythritol, a potent artificial sweetener
erythritol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of erythritol as a single oral dose. | 23 |
| Xylitol, 5g oral xylitol, a potent artificial sweetener
xylitol, 5g: Intervention is a drink consisting of 300mL of water containing 5g of xylitol as a single oral dose. | 5 |
| Glucose, 30g oral glucose, delivered as dextrose
glucose, 30g: Intervention is a drink consisting of 300mL of water containing 30g of glucose (dextrose) as a single oral dose. | 10 |
| Total | 48 |
Baseline characteristics
| Characteristic | Xylitol, 30g | Total | Glucose, 30g | Xylitol, 5g | Erythritol, 30g |
|---|---|---|---|---|---|
| Age, Continuous | 35.4 years STANDARD_DEVIATION 12.1 | 34.1 years STANDARD_DEVIATION 12.6 | 30.1 years STANDARD_DEVIATION 11.5 | 31.2 years STANDARD_DEVIATION 10.1 | 35.8 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 46 Participants | 9 Participants | 5 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 10 Participants | 2 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 33 Participants | 6 Participants | 3 Participants | 16 Participants |
| Region of Enrollment United States | 10 participants | 48 participants | 10 participants | 5 participants | 23 participants |
| Sex: Female, Male Female | 5 Participants | 26 Participants | 6 Participants | 3 Participants | 12 Participants |
| Sex: Female, Male Male | 5 Participants | 22 Participants | 4 Participants | 2 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 25 | 0 / 5 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 25 | 0 / 5 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 25 | 0 / 5 | 0 / 10 |
Outcome results
Primary
Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion
Measuring changes in levels of plasma polyols before versus after xylitol or erythritol ingestion, using established techniques by mass spectrometry. Xylitol concentrations are reported in the two xylitol intervention arms. Erythritol concentrations are reported in the erythritol and glucose intervention arms.
Time frame: Baseline and 30 minutes post ingestion of polyol intervention
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xylitol, 30g | Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion | Baseline | 0.30 umol/L (uM) |
| Xylitol, 30g | Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion | 30 minutes post-ingestion of polyol | 312.4 umol/L (uM) |
| Erythritol, 30g | Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion | 30 minutes post-ingestion of polyol | 6174.9 umol/L (uM) |
| Erythritol, 30g | Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion | Baseline | 3.8 umol/L (uM) |
| Xylitol, 5g | Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion | Baseline | 0.26 umol/L (uM) |
| Xylitol, 5g | Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion | 30 minutes post-ingestion of polyol | 0.97 umol/L (uM) |
| Glucose, 30g | Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion | Baseline | 3.0 umol/L (uM) |
| Glucose, 30g | Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion | 30 minutes post-ingestion of polyol | 2.9 umol/L (uM) |
Primary
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
Measuring changes in platelet function before versus after xylitol or erythritol ingestion, using established in vitro platelet assays. Platelet aggregation responses, based on changes in light transmission after adding different concentrations of the agonists ADP and TRAP6 are reported. A higher percentage of light transmission indicates an increased aggregation response, with maximum amplitude (100%) indicating total aggregation.
Time frame: Baseline and 30 minutes post ingestion of polyol intervention
Population: Only 10 of the 23 subjects consuming 30g of erythritol had aggregometry measurements performed. These were the last 10 subjects enrolled in this arm. The earlier subjects were only used to assess levels of erythritol following ingestion (pharmacokinetics studies) without looking at platelet function. The pharmacokinetics studies informed the subsequent aggregometry experiments in the final 10 subjects.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 1uM ADP at 30 minutes post polyol ingestion | 20.00 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 3uM ADP at Baseline | 30.00 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 7.5 uM TRAP6 at 30 minutes post polyol ingestion | 50.00 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2.5 uM TRAP6 at 30 minutes post polyol ingestion | 13.00 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 1uM ADP at Baseline | 11.00 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 3uM ADP at 30 minutes post polyol ingestion | 43.50 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2.5 uM TRAP6 at Baseline | 2.50 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 4uM ADP at Baseline | 45.00 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2 uM ADP at 30 minutes post polyol ingestion | 33.00 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 4uM ADP at 30 minutes post polyol ingestion | 57.00 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 5.0 uM TRAP6 at 30 minutes post polyol ingestion | 32.00 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2 uM ADP at Baseline | 21.00 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 7.5 uM TRAP6 at Baseline | 20.00 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 10.0 uM TRAP6 at Baseline | 45.50 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 5.0 uM TRAP6 at Baseline | 9.00 % of maximum amplitude |
| Xylitol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 10.0 uM TRAP6 at 30 minutes post polyol ingestion | 68.00 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2.5 uM TRAP6 at Baseline | 2.50 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 1uM ADP at Baseline | 11.00 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 10.0 uM TRAP6 at 30 minutes post polyol ingestion | 69.00 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2 uM ADP at 30 minutes post polyol ingestion | 34.00 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2.5 uM TRAP6 at 30 minutes post polyol ingestion | 15.00 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 7.5 uM TRAP6 at Baseline | 20.00 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 3uM ADP at Baseline | 30.00 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 1uM ADP at 30 minutes post polyol ingestion | 18.50 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 3uM ADP at 30 minutes post polyol ingestion | 42.50 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 4uM ADP at Baseline | 50.50 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 4uM ADP at 30 minutes post polyol ingestion | 66.50 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 10.0 uM TRAP6 at Baseline | 48.00 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 5.0 uM TRAP6 at 30 minutes post polyol ingestion | 26.00 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2 uM ADP at Baseline | 22.00 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 7.5 uM TRAP6 at 30 minutes post polyol ingestion | 45.00 % of maximum amplitude |
| Erythritol, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 5.0 uM TRAP6 at Baseline | 9.00 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 1uM ADP at Baseline | 11.00 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 3uM ADP at Baseline | 31.00 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2.5 uM TRAP6 at 30 minutes post polyol ingestion | 9.00 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 10.0 uM TRAP6 at Baseline | 60.00 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 5.0 uM TRAP6 at Baseline | 9.00 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 5.0 uM TRAP6 at 30 minutes post polyol ingestion | 16.50 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2 uM ADP at 30 minutes post polyol ingestion | 29.00 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 10.0 uM TRAP6 at 30 minutes post polyol ingestion | 78.00 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 7.5 uM TRAP6 at 30 minutes post polyol ingestion | 37.00 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 3uM ADP at 30 minutes post polyol ingestion | 44.00 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 1uM ADP at 30 minutes post polyol ingestion | 20.00 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 4uM ADP at Baseline | 52.00 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 7.5 uM TRAP6 at Baseline | 21.00 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 4uM ADP at 30 minutes post polyol ingestion | 72.50 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2 uM ADP at Baseline | 19.00 % of maximum amplitude |
| Xylitol, 5g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2.5 uM TRAP6 at Baseline | 2.00 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 4uM ADP at 30 minutes post polyol ingestion | 49.00 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 1uM ADP at Baseline | 11.50 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 1uM ADP at 30 minutes post polyol ingestion | 12.00 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2 uM ADP at Baseline | 21.00 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2 uM ADP at 30 minutes post polyol ingestion | 22.00 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 3uM ADP at Baseline | 30.00 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 4uM ADP at Baseline | 50.00 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2.5 uM TRAP6 at Baseline | 1.00 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 5.0 uM TRAP6 at Baseline | 9.00 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 5.0 uM TRAP6 at 30 minutes post polyol ingestion | 8.00 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 7.5 uM TRAP6 at Baseline | 19.00 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 7.5 uM TRAP6 at 30 minutes post polyol ingestion | 20.00 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 10.0 uM TRAP6 at Baseline | 61.50 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 10.0 uM TRAP6 at 30 minutes post polyol ingestion | 61.00 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 3uM ADP at 30 minutes post polyol ingestion | 31.00 % of maximum amplitude |
| Glucose, 30g | Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion | 2.5 uM TRAP6 at 30 minutes post polyol ingestion | 1.00 % of maximum amplitude |
Primary
Change From Baseline in Urinary Polyol Levels at 30 Minutes Post Polyol Ingestion
Measuring changes in levels of urinary polyols before versus after xylitol or erythritol ingestion, using established techniques by mass spectrometry. Xylitol was measured, and is reported below, in the two xylitol intervention arms and erythritol was measured, and is reported below, in the erythritol and glucose intervention arms.
Time frame: Baseline and 30 minutes post ingestion of polyol intervention
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xylitol, 30g | Change From Baseline in Urinary Polyol Levels at 30 Minutes Post Polyol Ingestion | Baseline | 42.24 uM |
| Xylitol, 30g | Change From Baseline in Urinary Polyol Levels at 30 Minutes Post Polyol Ingestion | 30-minutes Post Polyol Ingestion | 5242.00 uM |
| Erythritol, 30g | Change From Baseline in Urinary Polyol Levels at 30 Minutes Post Polyol Ingestion | 30-minutes Post Polyol Ingestion | 86832.00 uM |
| Erythritol, 30g | Change From Baseline in Urinary Polyol Levels at 30 Minutes Post Polyol Ingestion | Baseline | 372.56 uM |
| Xylitol, 5g | Change From Baseline in Urinary Polyol Levels at 30 Minutes Post Polyol Ingestion | Baseline | 18.92 uM |
| Xylitol, 5g | Change From Baseline in Urinary Polyol Levels at 30 Minutes Post Polyol Ingestion | 30-minutes Post Polyol Ingestion | 29.20 uM |
| Glucose, 30g | Change From Baseline in Urinary Polyol Levels at 30 Minutes Post Polyol Ingestion | Baseline | 393.84 uM |
| Glucose, 30g | Change From Baseline in Urinary Polyol Levels at 30 Minutes Post Polyol Ingestion | 30-minutes Post Polyol Ingestion | 225.56 uM |
Primary
Plasma Polyol Levels After Polyol Ingestion
Measuring plasma levels (uM) of polyols (xylitol or erythritol) 30 minutes after xylitol or erythritol ingestion, using established techniques by mass spectrometry. Xylitol was measured, and is reported below, in the two xylitol intervention arms and erythritol was measured, and is reported below, in the erythritol and glucose intervention arms.
Time frame: 30 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xylitol, 30g | Plasma Polyol Levels After Polyol Ingestion | 312.4 uM |
| Erythritol, 30g | Plasma Polyol Levels After Polyol Ingestion | 6174.9 uM |
| Xylitol, 5g | Plasma Polyol Levels After Polyol Ingestion | 0.97 uM |
| Glucose, 30g | Plasma Polyol Levels After Polyol Ingestion | 2.9 uM |
Primary
Platelet Aggregation After Polyol Ingestion
Measuring platelet function 30 minutes after polyol ingestion, using established in vitro platelet assays. Platelet aggregation responses, based on changes in light transmission after adding different concentrations of the agonists ADP and TRAP6 are reported. A higher percentage of light transmission indicates an increased aggregation response, with maximum amplitude (100%) indicating total aggregation.
Time frame: 30 minutes
Population: Only 10 of the 23 subjects consuming 30g of erythritol had aggregometry measurements performed. These were the last 10 subjects enrolled in this arm. The earlier subjects were only used to assess levels of erythritol following ingestion (pharmacokinetics studies) without looking at platelet function. The pharmacokinetics studies informed the subsequent aggregometry experiments in the final 10 subjects.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xylitol, 30g | Platelet Aggregation After Polyol Ingestion | ADP (1 uM) | 20.00 % of maximum amplitude |
| Xylitol, 30g | Platelet Aggregation After Polyol Ingestion | ADP (2 uM) | 33.00 % of maximum amplitude |
| Xylitol, 30g | Platelet Aggregation After Polyol Ingestion | ADP (3 uM) | 43.50 % of maximum amplitude |
| Xylitol, 30g | Platelet Aggregation After Polyol Ingestion | ADP (4 uM) | 57.00 % of maximum amplitude |
| Xylitol, 30g | Platelet Aggregation After Polyol Ingestion | TRAP6 (5.0uM) | 32.00 % of maximum amplitude |
| Xylitol, 30g | Platelet Aggregation After Polyol Ingestion | TRAP6 (7.5 uM) | 50.00 % of maximum amplitude |
| Xylitol, 30g | Platelet Aggregation After Polyol Ingestion | TRAP6 (10.0uM) | 68.00 % of maximum amplitude |
| Xylitol, 30g | Platelet Aggregation After Polyol Ingestion | TRAP6 (2.5uM) | 13.00 % of maximum amplitude |
| Erythritol, 30g | Platelet Aggregation After Polyol Ingestion | TRAP6 (7.5 uM) | 45.00 % of maximum amplitude |
| Erythritol, 30g | Platelet Aggregation After Polyol Ingestion | TRAP6 (5.0uM) | 26.00 % of maximum amplitude |
| Erythritol, 30g | Platelet Aggregation After Polyol Ingestion | ADP (2 uM) | 34.00 % of maximum amplitude |
| Erythritol, 30g | Platelet Aggregation After Polyol Ingestion | TRAP6 (2.5uM) | 15.00 % of maximum amplitude |
| Erythritol, 30g | Platelet Aggregation After Polyol Ingestion | TRAP6 (10.0uM) | 69.00 % of maximum amplitude |
| Erythritol, 30g | Platelet Aggregation After Polyol Ingestion | ADP (4 uM) | 66.50 % of maximum amplitude |
| Erythritol, 30g | Platelet Aggregation After Polyol Ingestion | ADP (3 uM) | 42.50 % of maximum amplitude |
| Erythritol, 30g | Platelet Aggregation After Polyol Ingestion | ADP (1 uM) | 18.50 % of maximum amplitude |
| Xylitol, 5g | Platelet Aggregation After Polyol Ingestion | TRAP6 (10.0uM) | 78.00 % of maximum amplitude |
| Xylitol, 5g | Platelet Aggregation After Polyol Ingestion | ADP (3 uM) | 44.00 % of maximum amplitude |
| Xylitol, 5g | Platelet Aggregation After Polyol Ingestion | ADP (4 uM) | 72.50 % of maximum amplitude |
| Xylitol, 5g | Platelet Aggregation After Polyol Ingestion | TRAP6 (5.0uM) | 16.50 % of maximum amplitude |
| Xylitol, 5g | Platelet Aggregation After Polyol Ingestion | TRAP6 (7.5 uM) | 37.00 % of maximum amplitude |
| Xylitol, 5g | Platelet Aggregation After Polyol Ingestion | TRAP6 (2.5uM) | 9.00 % of maximum amplitude |
| Xylitol, 5g | Platelet Aggregation After Polyol Ingestion | ADP (1 uM) | 20.00 % of maximum amplitude |
| Xylitol, 5g | Platelet Aggregation After Polyol Ingestion | ADP (2 uM) | 29.00 % of maximum amplitude |
| Glucose, 30g | Platelet Aggregation After Polyol Ingestion | ADP (3 uM) | 31.00 % of maximum amplitude |
| Glucose, 30g | Platelet Aggregation After Polyol Ingestion | ADP (4 uM) | 49.00 % of maximum amplitude |
| Glucose, 30g | Platelet Aggregation After Polyol Ingestion | ADP (2 uM) | 22.00 % of maximum amplitude |
| Glucose, 30g | Platelet Aggregation After Polyol Ingestion | ADP (1 uM) | 12.00 % of maximum amplitude |
| Glucose, 30g | Platelet Aggregation After Polyol Ingestion | TRAP6 (5.0uM) | 8.00 % of maximum amplitude |
| Glucose, 30g | Platelet Aggregation After Polyol Ingestion | TRAP6 (2.5uM) | 1.00 % of maximum amplitude |
| Glucose, 30g | Platelet Aggregation After Polyol Ingestion | TRAP6 (10.0uM) | 61.00 % of maximum amplitude |
| Glucose, 30g | Platelet Aggregation After Polyol Ingestion | TRAP6 (7.5 uM) | 20.00 % of maximum amplitude |
Primary
Urinary Polyol Levels After Polyol Ingestion
Measuring the urinary levels of polyols (xylitol or erythritol) 30 minutes after xylitol or erythritol ingestion, using established techniques by mass spectrometry. Xylitol was measured, and is reported below, in the two xylitol intervention arms and erythritol was measured, and is reported below, in the erythritol and glucose intervention arms.
Time frame: 30 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xylitol, 30g | Urinary Polyol Levels After Polyol Ingestion | 5242.00 uM |
| Erythritol, 30g | Urinary Polyol Levels After Polyol Ingestion | 86832.00 uM |
| Xylitol, 5g | Urinary Polyol Levels After Polyol Ingestion | 29.20 uM |
| Glucose, 30g | Urinary Polyol Levels After Polyol Ingestion | 225.56 uM |
Secondary
Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion
Measuring changes in lipid levels as markers of changes in metabolism before versus after xylitol or erythritol ingestion.
Time frame: Baseline and 1 day post ingestion of polyol intervention
Population: Not all subjects had blood drawn at 1 day post-sweetener ingestion. Blood samples at 1 day post ingestion were only obtained from 13 subjects who consumed 30g erythritol and 4 subjects who consumed 30g of xylitol. No subjects taking glucose or 5mg of xylitol had blood drawn at 1 day post-ingestion.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xylitol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | Calculated LDL at Baseline | 112.2 mg/dL |
| Xylitol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | HDL at Baseline | 50.6 mg/dL |
| Xylitol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | HDL at 1 day Post Polyol Ingestion | 48.4 mg/dL |
| Xylitol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | Triglycerides at Baseline | 108.5 mg/dL |
| Xylitol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | Triglycerides at 1 day Post Polyol Ingestion | 106.0 mg/dL |
| Xylitol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | Calculated LDL at 1 day Post Polyol Ingestion | 134.0 mg/dL |
| Xylitol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | Total Cholesterol at 1 day Post Polyol Ingestion | 203.5 mg/dL |
| Xylitol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | Total Cholesterol at Baseline | 218.5 mg/dL |
| Erythritol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | Calculated LDL at 1 day Post Polyol Ingestion | 97.0 mg/dL |
| Erythritol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | Total Cholesterol at 1 day Post Polyol Ingestion | 168.0 mg/dL |
| Erythritol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | Triglycerides at 1 day Post Polyol Ingestion | 86.0 mg/dL |
| Erythritol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | HDL at Baseline | 51.6 mg/dL |
| Erythritol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | Calculated LDL at Baseline | 91.0 mg/dL |
| Erythritol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | HDL at 1 day Post Polyol Ingestion | 52.4 mg/dL |
| Erythritol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | Total Cholesterol at Baseline | 168.0 mg/dL |
| Erythritol, 30g | Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion | Triglycerides at Baseline | 80.0 mg/dL |