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| Name | Class |
|---|---|
| University of Oxford | OTHER |
| British Heart Foundation | OTHER |
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This study aims to determine to what extent ingestion of free sugars influence postprandial triglyceridaemia in men and women.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maltodextrin | Sham Comparator | Glucose polymer; a common sugar substitute |
|
| Sucrose | Active Comparator | Fructose-glucose disaccharide |
|
| Lactose | Experimental | Galactose-glucose disaccharide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maltodextrin | Dietary Supplement | Co-ingestion of maltodextrin with a high fat meal |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial de Novo Lipogenesis (DNL) | Time course for synthesis of fatty acids from non-lipid precursors using stable isotope methodology | 6 hours |
| Dietary Fat Oxidation | Time course for whole-body dietary fatty acid oxidation using stable isotope methodology |
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Inclusion Criteria:
• Age: 18-50 years and premenopausal (for women)
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department for Health, University of Bath | Bath | Somerset | BA2 7AY | United Kingdom |
Raw data will be made available online upon publication in a peer-reviewed journal.
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2 dropouts
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Sucrose first, then Lactose, then Maltodextrin |
| FG001 | Sequence 2 | Sucrose first, then Maltodextrin, then Lactose |
| FG002 | Sequence 3 | Lactose first, then Sucrose, then Maltodextrin |
| FG003 | Sequence 4 | Lactose first, then Maltodextrin, then Sucrose |
| FG004 | Sequence 5 | Maltodextrin first, then Sucrose, then Lactose |
| FG005 | Sequence 6 | Maltodextrin first, then Lactose, then Sucrose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
| |||||||||||||
| Period 3 |
|
Crossover design so n = 24 for all arms
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants completed all conditions/arms and hence are pooled for baseline measures |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | mmol/L x 360 min | 6 hours |
|
6 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maltodextrin | Glucose polymer; a common sugar substitute Maltodextrin: Co-ingestion of maltodextrin with a high fat meal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Javier Gonzalez | University of Bath | 01225 38 | 5518 | j.t.gonzalez@bath.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2021 | Oct 3, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
| D013395 | Sucrose |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Sucrose |
| Dietary Supplement |
Co-ingestion of sucrose with a high fat meal |
|
| Lactose | Dietary Supplement | Co-ingestion of lactose with a high fat meal |
|
| 6 hours |
| Postprandial Changes in Plasma Insulin Concentrations | Incremental area under the curve (iAUC) of plasma insulin concentrations | 6 hours |
| Postprandial Changes in Plasma Glucose Concentrations | Incremental area under the curve (iAUC) of plasma glucose concentrations | 6 hours |
| Postprandial Changes in Plasma Galactose Concentrations | Incremental area under the curve (iAUC) of plasma galactose concentrations | 6 hours |
| Postprandial Changes in Plasma Fructose Concentrations | Incremental area under the curve (iAUC) of plasma fructose concentrations | 6 hours |
| 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 | 6 hours |
| Postprandial Changes in Plasma Chylomicron-rich Triglyceride (Sf: >400) Concentrations | Incremental area under the curve (iAUC) of plasma chylomicron-rich triglyceride (Sf: >400) concentrations | 6 hours |
| Postprandial Changes in Plasma Lactate Concentrations | Incremental area under the curve (iAUC) of plasma lactate concentrations | 6 hours |
| Postprandial Changes in Plasma Non-esterified Fatty Acid Concentrations | Incremental area under the curve (iAUC) of plasma non-esterified fatty acid concentrations | 6 hours |
| Postprandial Changes in Plasma Beta-hydroxybutyrate Concentrations | Incremental area under the curve (iAUC) of plasma beta-hydroxybutyrate concentrations | 6 hours |
| Postprandial Changes in Plasma Uric Acid Concentrations | Incremental area under the curve (iAUC) of plasma uric acid concentrations | 6 hours |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height (m) | Mean | Standard Deviation | meters |
|
| Body mass (kg) | Mean | Standard Deviation | kg |
|
| Body mass index (kg/m^2) | Mean | Standard Deviation | kg/m2 |
|
| Body fat (percentage of mass) | Mean | Standard Deviation | % |
|
| Fat mass (kg) | Mean | Standard Deviation | kg |
|
| Fat-free mass (kg) | Mean | Standard Deviation | kg |
|
Galactose-glucose disaccharide Lactose: Co-ingestion of lactose with a high fat meal |
|
|
| Secondary | Postprandial de Novo Lipogenesis (DNL) | Time course for synthesis of fatty acids from non-lipid precursors using stable isotope methodology | Not Posted | 6 hours | Participants |
| Secondary | Dietary Fat Oxidation | Time course for whole-body dietary fatty acid oxidation using stable isotope methodology | Not Posted | 6 hours | Participants |
| Secondary | Postprandial Changes in Plasma Insulin Concentrations | Incremental area under the curve (iAUC) of plasma insulin concentrations | Not Posted | 6 hours | Participants |
| Secondary | Postprandial Changes in Plasma Glucose Concentrations | Incremental area under the curve (iAUC) of plasma glucose concentrations | Not Posted | 6 hours | Participants |
| Secondary | Postprandial Changes in Plasma Galactose Concentrations | Incremental area under the curve (iAUC) of plasma galactose concentrations | Not Posted | 6 hours | Participants |
| Secondary | Postprandial Changes in Plasma Fructose Concentrations | Incremental area under the curve (iAUC) of plasma fructose concentrations | Not Posted | 6 hours | Participants |
| 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 | Not Posted | 6 hours | Participants |
| 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 | Not Posted | 6 hours | Participants |
| Secondary | Postprandial Changes in Plasma Lactate Concentrations | Incremental area under the curve (iAUC) of plasma lactate concentrations | Not Posted | 6 hours | Participants |
| Secondary | Postprandial Changes in Plasma Non-esterified Fatty Acid Concentrations | Incremental area under the curve (iAUC) of plasma non-esterified fatty acid concentrations | Not Posted | 6 hours | Participants |
| Secondary | Postprandial Changes in Plasma Beta-hydroxybutyrate Concentrations | Incremental area under the curve (iAUC) of plasma beta-hydroxybutyrate concentrations | Not Posted | 6 hours | Participants |
| Secondary | Postprandial Changes in Plasma Uric Acid Concentrations | Incremental area under the curve (iAUC) of plasma uric acid concentrations | Not Posted | 6 hours | Participants |
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Sucrose | Fructose-glucose disaccharide Sucrose: Co-ingestion of sucrose with a high fat meal | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Lactose | Galactose-glucose disaccharide Lactose: Co-ingestion of lactose with a high fat meal | 0 | 24 | 0 | 24 | 0 | 24 |
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| D000073893 |
| Sugars |