Health Effects of Grain Foods in Adults

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.

Study Overview

• Status: Recruiting
• 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
• Intervention / Treatment: Other: High Whole Grain, Low Sugar; Other: Low Whole Grain, Low Sugar; Other: High Whole Grain, High Sugar; Other: Low Whole Grain, High Sugar

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Judy George, BS; Phone Number: 4654946192; Email: georgej@purdue.edu
• Study Contact Backup: Name: Richard Mattes, PhD; Phone Number: 7654940662; Email: mattes@purdue.edu

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 17907
      • Recruiting
      • Purdue University
      • Contact: Richard D Mattes, PhD; Phone Number: 765-494-0662; Email: mattes@purdue.edu
      • Principal Investigator: Richard D Mattes, PhD, RD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High Whole Grain, Low Sugar; 6 servings of whole grain and <13% energy from added sugars.	Other: 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.	Other: 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.	Other: 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.	Other: Low Whole Grain, High Sugar; 3 servings of whole grain and >13% energy from added sugars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemia	blood sugar	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appetite	ingestive sensations measured by VAS ratings	12 weeks
Taste Hedonics	palatability	12 weeks
Energy Intake	kcals	12 weeks
Body Weight	pounds	12 weeks
Lipemia	Blood lipids	12 weeks
Systolic and Diastolic Blood Pressure	mm mercury	12 weeks

Collaborators and Investigators

• Sponsor: Purdue University
• Collaborators: Grain Food Foundation
• Investigators: Principal Investigator: Richard Mattes, PhD, Purdue University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: appetite; blood pressure; microbiome; body weight; food intake; glycemia; whole grain; refined grain; lipemia; hedonics
• Other Study ID Numbers: IRB-2023-1071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: deidentified data will be shared.

Drug and device information, study documents

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