Skip to main content
OpenTrials
Completed

NCT Number: NCT03458858

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA-ARS Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mixed Berry Diet

Other

Mixed Berry Treatment

Carbohydrate Control Jello

Other

Carbohydrate Control

Fiber Enriched Jello

Other

Fiber Control

Low Fiber Mixed Berry Juice

Other

Anthocyanin Control

Primary outcomes

  1. Glucose Metabolism Phase 1

    Time frame: Day 8

    Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.

  2. Glucose Metabolism Phase 2

    Time frame: Day 29

    Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.

  3. Glucose Metabolism Phase 3

    Time frame: Day 50

    Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.

  4. Glucose Metabolism Phase 4

    Time frame: Day 71

    Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.

Secondary outcomes

  1. Insulin sensitivity

    Time frame: 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.

  2. Fat trafficking

    Time frame: 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.

  3. Peripheral mononuclear blood cells energetics

    Time frame: 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.

  4. Metabolic Fuel Use

    Time frame: 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.

Other outcomes

  1. Metabolomics in blood

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2018
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.