Berry Components and Blood Sugar & Fat Metabolism

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Mixed Berry Diet; Other: Carbohydrate Control Jello; Other: Fiber Enriched Jello; Other: Low Fiber Mixed Berry Juice

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • USDA-ARS Beltsville Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Mixed Berry Diet; Participants will receive between 400 to 800 grams of mixed berries daily, as a proportion of their daily caloric intake added to their base diet. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.	Other: Mixed Berry Diet; Mixed Berry Treatment
Other: Carbohydrate Control Jello; Participants will receive between 400 to 800 grams of strawberry jello daily, as a proportion of their daily caloric intake added to their base diet. The jello will be matched to the mixed berries in both total carbohydrate level and gram quantity. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.	Other: Carbohydrate Control Jello; Carbohydrate Control
Other: Fiber Enriched Jello; Participants will receive between 400 to 800 grams of fiber enriched strawberry jello daily, as a proportion of their daily caloric intake added to their base diet. The jello will be matched to the mixed berries in both total carbohydrate level and fiber content, and in the same gram quantity. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.	Other: Fiber Enriched Jello; Fiber Control
Other: Low Fiber Mixed Berry Juice; Participants will receive 1 liter per day of low fiber mixed berry juice added to their base diet. The juice will be squeezed from the mixed berries, then filtered. The sugar level of the juice will match that of the mixed berries. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.	Other: Low Fiber Mixed Berry Juice; Anthocyanin Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: USDA Beltsville Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): June 28, 2018

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HS59

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No