Healthy Volunteers
Conditions
Brief summary
The primary objective of this study is to determine which components of berries improve glucose metabolism and increase fat oxidation in humans.
Detailed description
The aim of this study is to improve understanding of how diet can regulate glucose metabolism and fuel use. Previous human and animal studies have demonstrated that berries can improve gluco-regulation and increase fat oxidation. The aim of this study is to determine which component of berries is conveying this health benefit.
Interventions
OTHERLow Fiber Mixed Berry Juice
Anthocyanin Control
OTHERCarbohydrate Control Jello
Carbohydrate Control
OTHERFiber Enriched Jello
Fiber Control
OTHERMixed Berry Diet
Mixed Berry Treatment
Sponsors
USDA Beltsville Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy non-smoker * able to understand consent
Exclusion criteria
* Body Mass Index less than 25 kg/m2 * pregnant, lactating, having given birth in the past year * allergy to berries * blood glucose greater than 125 mg/dL * history of bariatric surgery or nutrient malabsorption disease * diagnosis or treatment of cancer in past three years * type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Metabolism Phase 4 | Day 71 | Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L. |
| Glucose Metabolism Phase 1 | Day 8 | Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L. |
| Glucose Metabolism Phase 2 | Day 29 | Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L. |
| Glucose Metabolism Phase 3 | Day 50 | Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Fuel Use | Day 7-8, 28-29, 49-50, 70-71 | Subjects will spend the night in an indirect calorimeter to measure their oxygen consumption and carbon dioxide evolution which will be used to calculate the dietary energy source being oxidized, expressed as respiratory quotient which is a unitless ratio of liters of O2 inhaled to liters of CO2 exhaled. |
| Insulin sensitivity | Day 8, 29, 50, 71 | Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for insulin in units of microIU/mL. |
| Fat trafficking | Day 8, 29, 50, 71 | Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for non-esterified fatty acids in mmol/L. |
| Peripheral mononuclear blood cells energetics | Day 8, 29, 50, 71 | Blood cells called peripheral mononuclear blood cells will be isolated and analyzed for mitochondrial function/oxygen consumption in nmol/ml. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Metabolomics in blood | Day 8, 29, 50, 71 | Blood metabolomics profiling will be conducted by gas chromatography and liquid chromatography / time-of-flight mass spectrometry. Selected intensity of biochemicals in blood with mass ranging from 50 to 800 molecular weight will be assessed. |
Countries
United States
Outcome results
None listed