Health Effects of Grain Foods in Adults

Part of paid clinical trials in West Lafayette, Indiana.

Sponsor
Purdue University
Study ID
NCT06339879
Status
Recruiting

Conditions

  • High Whole Grain and Low Sugar
  • Low Whole Grain and High Sugar
  • Low Whole Grain and Low Sugar
  • Medium Whole Grain and Low Sugar

Eligibility Criteria

Sex
ALL
Age
21 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • High Whole Grain, Low Sugar — OTHER
    6 servings of whole grain and \<13% energy from added sugars.
  • Low Whole Grain, Low Sugar — OTHER
    3 servings of whole grain and \<13% energy from added sugars.
  • High Whole Grain, High Sugar — OTHER
    6 servings of whole grain and \>13% energy from added sugars.
  • Low Whole Grain, High Sugar — OTHER
    3 servings of whole grain and \>13% energy from added sugars.

Study Details

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.

Key Dates

Start date
Jan 18, 2024
Status verified
Jul 2024
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

Glycemia [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Purdue UniversityWest LafayetteIndiana17907
Richard D Mattes, PhD
765-494-0662
Richard D Mattes, PhD, RD, MPH (PRINCIPAL_INVESTIGATOR)

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