Obesity
Conditions
Keywords
obesity, diabetes, artificial sweeteners
Brief summary
Several sugar-replacement sweeteners are currently on the market, including saccharine (ex. Sweet'N Low), aspartame (ex. Equal), and sucralose (ex. Splenda). The purpose of this study is to examine wether non caloric sweeteners affects how well the body works to control blood sugar. The study includes detailed blood sugar testing after drinking liquids that may contain sucralose. The investigators hypothesize that drinking liquids with sucralose will effect the amounts of specific appetite-affecting substances naturally produced by the body.
Interventions
OTHERWater
60 ml of water were drank 10 min before doing a OGTT
OTHERSucralose
60 ml of 2 millimolar sucralose were drank 10 min before doing a OGTT
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* body mass index (BMI) over 30. * Homeostasis model assessment of insulin resistance (HOMA-IR) \< or = 2.6
Exclusion criteria
* smoking or smoked within last six months * pregnant or breastfeeding * have malabsorptive syndromes * intestinal inflammatory disease * diabetes * liver or kidney disease * fructose intolerance * consuming more than one can of diet beverage or one spoonful of non-nutritive sweeteners (e.g. sucralose, aspartame, or saccharine) a week. * taking any medication that might affect metabolism or taste.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC) | Baseline | we will measure plasma insulin concentrations during a 5-hour modified Oral Glucose Tolerance Test (mOGTT) administered 10 minutes after subjects consume sucralose in water or an equal volume of water without sucralose (control condition).Plasma insulin concentrations were measured at 20, 15, 10, 6, and 2 min before and at 10, 20, 30, 40, 60, 90, 120, 150,180, 240, and 300 min after ingesting 75g of glucose. All these data collected were used to create the AUC curve. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Obese Non Regular Users of Non Nutritive Sweeteners (NNS) Obese subjects who do not use NNS and are insulin-sensitive (based on a Homeostasis Model Assessment of Insulin Resistance score \<or =2.6). | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Obese Non Regular Users of Non Nutritive Sweeteners (NNS) |
|---|---|
| Age, Continuous | 35.1 years STANDARD_DEVIATION 4.1 |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC)
we will measure plasma insulin concentrations during a 5-hour modified Oral Glucose Tolerance Test (mOGTT) administered 10 minutes after subjects consume sucralose in water or an equal volume of water without sucralose (control condition).Plasma insulin concentrations were measured at 20, 15, 10, 6, and 2 min before and at 10, 20, 30, 40, 60, 90, 120, 150,180, 240, and 300 min after ingesting 75g of glucose. All these data collected were used to create the AUC curve.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Obese Non Regular Users of Non Nutritive Sweeteners (NNS) | The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC) | Insulin AUC on water day | 57,192 (pmol • min •L-1) |
| Obese Non Regular Users of Non Nutritive Sweeteners (NNS) | The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC) | Insulin AUC on sucralose day | 68,647 (pmol • min •L-1) |
Comparison: Each subject served as their own control. We compared insulin concentrations when subjects consumed sucralose before a glucose load (experimental condition) with those on the day consumed water before a glucose load (control condition).p-value: 0.025t-test, 2 sided