Recruiting

Grain Foods

Sponsor:

Purdue University

Code:

NCT06339879

Conditions

High Whole Grain and Low Sugar

Medium Whole Grain and Low Sugar

Low Whole Grain and Low Sugar

Low Whole Grain and High Sugar

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

Interventions

High Whole Grain, Low Sugar

Low Whole Grain, Low Sugar

High Whole Grain, High Sugar

Low Whole Grain, High Sugar

Study Details

Brief summary:

This study will assess the effects of eating whole grain foods versus refined grain foods with different amounts of added sugar. It is hypothesized that a diet including grain products will have beneficial effects on taste hedonics, appetite, food/energy intake, body weight, blood pressure, acute and chronic glycemia and acute and chronic lipemia compared to customary diets controlling for added sugars, saturated fats and sodium.

Conditions

High Whole Grain and Low Sugar

Medium Whole Grain and Low Sugar

Low Whole Grain and Low Sugar

Low Whole Grain and High Sugar

Study ID

NCT06339879

Start date

Jan 18, 2024

Status verified date

Jul, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • male and female; 21 to 60 years old; Hemoglobin A1c concentration between 5.7 and 6.4%
  • Prefer no use of medications, but if on medication, must have been on a stable dose for 3 months and plan to remain at the same dose for the duration of the trial.
  • low customary intake of whole grain foods (less than 2 servings per day) and high energy from added sugar (greater than 10% energy).

Exclusion Criteria:

  • Grain or dairy sensitivities or allergies or celiac disease; sensitivity or allergy to other foods that would result in refusal to eat a class of foods.
  • smoker
  • intended weight loss or gain during the study period; intended change of activity level during the study period
  • use of blood thinners
  • prior gastrointestinal surgery.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: High Whole Grain, Low Sugar

6 servings of whole grain and <13% energy from added sugars.

active comparator: Low Whole Grain, Low Sugar

3 servings of whole grain and <13% energy from added sugars.

active comparator: High Whole Grain, High Sugar

6 servings of whole grain and >13% energy from added sugars.

active comparator: Low Whole Grain, High Sugar

3 servings of whole grain and >13% energy from added sugars.

Interventions

High Whole Grain, Low Sugar

6 servings of whole grain and <13% energy from added sugars.

Low Whole Grain, Low Sugar

3 servings of whole grain and <13% energy from added sugars.

High Whole Grain, High Sugar

6 servings of whole grain and >13% energy from added sugars.

Low Whole Grain, High Sugar

3 servings of whole grain and >13% energy from added sugars.

Primary outcome measure

  • Glycemia [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Judy George, BS

4654946192georgej@purdue.edu

Richard Mattes, PhD

7654940662mattes@purdue.edu

Locations

Purdue University

Recruiting

West Lafayette, Indiana, United States, 17907

Contacts

Richard D Mattes, PhD

765-494-0662mattes@purdue.edu

Principal Investigator:

Richard D Mattes, PhD, RD, MPH

More Information

Sponsor

Purdue University

Last update posted

Jul 15, 2024

Last verified

Jul, 2024

Keywords

  • whole grain
  • refined grain
  • glycemia
  • appetite
  • food intake
  • microbiome
  • body weight
  • blood pressure
  • lipemia
  • hedonics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Purdue University on 2024-07-15.