Cardiovascular Risk Factor, Lipaemia, Metabolic Disease
Conditions
Brief summary
This study aims to determine to what extent ingestion of free sugars influence postprandial triglyceridaemia in men and women.
Detailed description
Each participant will undergo three experimental trials in a randomized, crossover research design. On each study day, participants will consume a test drink containing standardised amounts of carbohydrate and fat followed by collection of blood and breath samples to assess metabolic responses during the 6 hour postprandial period. Trials will be identical except for the type of carbohydrate contained within the test drink: 1) maltodextrin (glucose polymer), 2) lactose (galactose-glucose disaccharide) and 3) sucrose (fructose-glucose disaccharide).
Interventions
DIETARY_SUPPLEMENTMaltodextrin
Co-ingestion of maltodextrin with a high fat meal
DIETARY_SUPPLEMENTSucrose
Co-ingestion of sucrose with a high fat meal
DIETARY_SUPPLEMENTLactose
Co-ingestion of lactose with a high fat meal
Sponsors
University of Oxford
British Heart Foundation
University of Bath
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
• Age: 18-50 years and premenopausal (for women)
Exclusion criteria
* Weight instability (\>5 kg change in body mass within last 6 months) * Diagnosis of any form of diabetes * Intolerances or allergies to any of the study procedures (e.g. lactose intolerance) * Galactose disorders (e.g. galactokinase deficiency, UDPgalactose-4-epimerase deficiency, galactose-1-phosphate uridyl transferase deficiency) * Fructose malabsorption * Inborn errors of fructose metabolism (e.g. fructokinase deficiency, aldolase B deficiency, fructose-1,6-bisphosphatase deficiency) * Pregnant or lactating * Any condition that could introduce bias to the study (e.g. diagnoses of lipid disorders, including cardiovascular disease, or therapies that alter lipid or glucose metabolism, such as statins or niacin).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Changes in Plasma Triglyceride Concentrations | 6 hours | Incremental area under the curve (iAUC) of plasma triglyceride concentrations from timepoints 0, 30, 60, 120, 180, 240, 300, 360 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Fat Oxidation | 6 hours | Time course for whole-body dietary fatty acid oxidation using stable isotope methodology |
| Postprandial Changes in Plasma Insulin Concentrations | 6 hours | Incremental area under the curve (iAUC) of plasma insulin concentrations |
| Postprandial Changes in Plasma Glucose Concentrations | 6 hours | Incremental area under the curve (iAUC) of plasma glucose concentrations |
| Postprandial Changes in Plasma Galactose Concentrations | 6 hours | Incremental area under the curve (iAUC) of plasma galactose concentrations |
| Postprandial Changes in Plasma Fructose Concentrations | 6 hours | Incremental area under the curve (iAUC) of plasma fructose concentrations |
| Postprandial de Novo Lipogenesis (DNL) | 6 hours | Time course for synthesis of fatty acids from non-lipid precursors using stable isotope methodology |
| Postprandial Changes in Plasma Chylomicron-rich Triglyceride (Sf: >400) Concentrations | 6 hours | Incremental area under the curve (iAUC) of plasma chylomicron-rich triglyceride (Sf: \>400) concentrations |
| Postprandial Changes in Plasma Lactate Concentrations | 6 hours | Incremental area under the curve (iAUC) of plasma lactate concentrations |
| Postprandial Changes in Plasma Non-esterified Fatty Acid Concentrations | 6 hours | Incremental area under the curve (iAUC) of plasma non-esterified fatty acid concentrations |
| Postprandial Changes in Plasma Beta-hydroxybutyrate Concentrations | 6 hours | Incremental area under the curve (iAUC) of plasma beta-hydroxybutyrate concentrations |
| Postprandial Changes in Plasma Uric Acid Concentrations | 6 hours | Incremental area under the curve (iAUC) of plasma uric acid concentrations |
| Postprandial Changes in Plasma VLDL-rich Triglyceride [Svedberg Flotation Rate (Sf): 20-400] Concentrations | 6 hours | Incremental area under the curve (iAUC) of plasma VLDL-rich triglyceride \[Svedberg flotation rate (Sf): 20-400\] concentrations |
Countries
United Kingdom
Participant flow
Pre-assignment details
2 dropouts
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants completed all conditions/arms and hence are pooled for baseline measures | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 24 years STANDARD_DEVIATION 6 | — |
| Body fat (percentage of mass) | 27 % STANDARD_DEVIATION 9 | — |
| Body mass index (kg/m^2) | 23.3 kg/m2 STANDARD_DEVIATION 2.2 | — |
| Body mass (kg) | 72.7 kg STANDARD_DEVIATION 12.9 | — |
| Fat-free mass (kg) | 53.8 kg STANDARD_DEVIATION 12 | — |
| Fat mass (kg) | 19.4 kg STANDARD_DEVIATION 7.3 | — |
| Height (m) | 1.77 meters STANDARD_DEVIATION 0.11 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 24 participants | — |
| Sex: Female, Male Female | 12 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
Primary
Postprandial Changes in Plasma Triglyceride Concentrations
Incremental area under the curve (iAUC) of plasma triglyceride concentrations from timepoints 0, 30, 60, 120, 180, 240, 300, 360 minutes
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maltodextrin | Postprandial Changes in Plasma Triglyceride Concentrations | 51 mmol/L x 360 min | Standard Deviation 68 |
| Sucrose | Postprandial Changes in Plasma Triglyceride Concentrations | 90 mmol/L x 360 min | Standard Deviation 95 |
| Lactose | Postprandial Changes in Plasma Triglyceride Concentrations | 98 mmol/L x 360 min | Standard Deviation 88 |
Secondary
Dietary Fat Oxidation
Time course for whole-body dietary fatty acid oxidation using stable isotope methodology
Time frame: 6 hours
Secondary
Postprandial Changes in Plasma Beta-hydroxybutyrate Concentrations
Incremental area under the curve (iAUC) of plasma beta-hydroxybutyrate concentrations
Time frame: 6 hours
Secondary
Postprandial Changes in Plasma Chylomicron-rich Triglyceride (Sf: >400) Concentrations
Incremental area under the curve (iAUC) of plasma chylomicron-rich triglyceride (Sf: \>400) concentrations
Time frame: 6 hours
Secondary
Postprandial Changes in Plasma Fructose Concentrations
Incremental area under the curve (iAUC) of plasma fructose concentrations
Time frame: 6 hours
Secondary
Postprandial Changes in Plasma Galactose Concentrations
Incremental area under the curve (iAUC) of plasma galactose concentrations
Time frame: 6 hours
Secondary
Postprandial Changes in Plasma Glucose Concentrations
Incremental area under the curve (iAUC) of plasma glucose concentrations
Time frame: 6 hours
Secondary
Postprandial Changes in Plasma Insulin Concentrations
Incremental area under the curve (iAUC) of plasma insulin concentrations
Time frame: 6 hours
Secondary
Postprandial Changes in Plasma Lactate Concentrations
Incremental area under the curve (iAUC) of plasma lactate concentrations
Time frame: 6 hours
Secondary
Postprandial Changes in Plasma Non-esterified Fatty Acid Concentrations
Incremental area under the curve (iAUC) of plasma non-esterified fatty acid concentrations
Time frame: 6 hours
Secondary
Postprandial Changes in Plasma Uric Acid Concentrations
Incremental area under the curve (iAUC) of plasma uric acid concentrations
Time frame: 6 hours
Secondary
Postprandial Changes in Plasma VLDL-rich Triglyceride [Svedberg Flotation Rate (Sf): 20-400] Concentrations
Incremental area under the curve (iAUC) of plasma VLDL-rich triglyceride \[Svedberg flotation rate (Sf): 20-400\] concentrations
Time frame: 6 hours
Secondary
Postprandial de Novo Lipogenesis (DNL)
Time course for synthesis of fatty acids from non-lipid precursors using stable isotope methodology
Time frame: 6 hours