Berry Components and Blood Sugar & Fat Metabolism

Healthy Volunteers Clinical Trial

Official title:

Berry Components and Blood Sugar & Fat Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458858
• Other study ID #: HS59
• Status: Completed
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: June 28, 2018

Study information

• Verified date: May 2019
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine which components of berries improve glucose metabolism and increase fat oxidation in humans.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 28, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Mixed Berry Diet
Mixed Berry Treatment
• Carbohydrate Control Jello
Carbohydrate Control
• Fiber Enriched Jello
Fiber Control
• Low Fiber Mixed Berry Juice
Anthocyanin Control

Locations

Country	Name	City	State
United States	USDA-ARS Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolomics in blood	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.	Day 8, 29, 50, 71
Primary	Glucose Metabolism Phase 1	Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.	Day 8
Primary	Glucose Metabolism Phase 2	Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.	Day 29
Primary	Glucose Metabolism Phase 3	Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.	Day 50
Primary	Glucose Metabolism Phase 4	Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.	Day 71
Secondary	Insulin sensitivity	Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for insulin in units of microIU/mL.	Day 8, 29, 50, 71
Secondary	Fat trafficking	Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for non-esterified fatty acids in mmol/L.	Day 8, 29, 50, 71
Secondary	Peripheral mononuclear blood cells energetics	Blood cells called peripheral mononuclear blood cells will be isolated and analyzed for mitochondrial function/oxygen consumption in nmol/ml.	Day 8, 29, 50, 71
Secondary	Metabolic Fuel Use	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.	Day 7-8, 28-29, 49-50, 70-71