Health Effects of Grain Foods in Adults

NCT ID: NCT06339879

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2026-12-31

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.

Detailed Description

This 16-week, randomized, controlled, parallel-arm, clinical trial will assess the effects of consuming four different categories of grain foods on taste hedonics, appetite, food/energy intake, body weight, and blood pressure as well as acute and longer-term glycemia and lipemia. It will also examine the effects of foods varying in grain/carbohydrate composition on the microbiome and microbiota functionality. One hundred and twenty adults will be recruited and randomly assigned to one of four intervention groups. These groups will be defined by the diets they are prescribed. All will be prescribed diets containing approximately 50%; 35% and 15% energy from carbohydrate, fat and protein, respectively. Grain foods will comprise 50% of the carbohydrate component (i.e., 25% of total energy). The grain foods will be assigned to one of four categories based on whole grain content and concentrations of added sugars. The grain foods meeting these criteria will have the following composition:

Group 1 - High Whole Grain, Low Sugar 6 servings of whole grain and <13% energy from added sugars.

Group 2 - Low Whole Grain, Low Sugar 3 servings of whole grain and <13% energy from added sugars.

Group 3 - High Whole Grain, High Sugar 6 servings of whole grain and >13% energy from added sugars.

Group 4 - Low Whole Grain, High Sugar 3 servings of whole grain and >13% energy from added sugars.

Detailed Study Design

The study measures and timing are outlined in the following table:

Screening Week 1 Baseline Week 2 Week 5 Week 8 Week 11 Week 14 Fasting Blood X X X XX MTT X X X Weight X X X X X X Body Composition X X CGM X X X Intake X Hedonics (palatability) X X X Appetite X X X Activity X X X Blood Pressure X X X X X X Microbiota X X X X X Compliance X X X X X MTT = Meal Tolerance Test; DXA= Dual-energy X-ray Absorptiometry; CGM=Continuous glucose monitoring

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

High Whole Grain, Low Sugar

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

Group Type: ACTIVE_COMPARATOR

High Whole Grain, Low Sugar

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

Low Whole Grain, Low Sugar

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

High Whole Grain, High Sugar

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

Low Whole Grain, High Sugar

Intervention Type: OTHER

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.

Intervention Type: OTHER

Low Whole Grain, Low Sugar

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

Intervention Type: OTHER

High Whole Grain, High Sugar

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

Intervention Type: OTHER

Low Whole Grain, High Sugar

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Grain Foods Foundation

UNKNOWN

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Richard Mattes

Distinguished Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Mattes, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

Purdue University

West Lafayette, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Judy George, BS

Role: CONTACT

georgej@purdue.edu

4654946192

Richard Mattes, PhD

Role: CONTACT

mattes@purdue.edu

7654940662

Facility Contacts

Richard D Mattes, PhD

Role: primary

mattes@purdue.edu

765-494-0662

Other Identifiers

IRB-2023-1071

Identifier Type: -

Identifier Source: org_study_id