Berry Components and Blood Sugar & Fat Metabolism

NCT03458858 | Completed

• 1 other identifier: HS59
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Insulin sensitivity

  Day 8, 29, 50, 71

• Fat trafficking

  Day 8, 29, 50, 71

• Peripheral mononuclear blood cells energetics

  Day 8, 29, 50, 71

• Metabolic Fuel Use

  Day 7-8, 28-29, 49-50, 70-71

Other Outcomes (1)

• Metabolomics in blood

  Day 8, 29, 50, 71

Study Arms (4)

Mixed Berry Diet

OTHER

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

Carbohydrate Control Jello

OTHER

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

Fiber Enriched Jello

OTHER

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

Low Fiber Mixed Berry Juice

OTHER

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

Interventions

Mixed Berry Diet OTHER

Mixed Berry Treatment

Mixed Berry Diet

Carbohydrate Control Jello OTHER

Carbohydrate Control

Carbohydrate Control Jello

Fiber Enriched Jello OTHER

Fiber Control

Fiber Enriched Jello

Low Fiber Mixed Berry Juice OTHER

Anthocyanin Control

Low Fiber Mixed Berry Juice

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy non-smoker
• able to understand consent

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA Beltsville Human Nutrition Research Center: lead

Study Sites (1)

USDA-ARS Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physiologist

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: March 8, 2018
• Study Start: February 13, 2018
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)