Effects of different grain foods on health in adults
Health Effects of Grain Foods in Adults
This study is testing how different types of grain foods, like whole grains and refined grains, affect health in adults over 16 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | Purdue University Academic / other |
| Locations | 1 site (West Lafayette, Indiana) |
| Trial ID | NCT06339879 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the health effects of consuming various types of grain foods, specifically comparing whole grain and refined grain options with differing sugar levels. Over 16 weeks, 120 adults will be randomly assigned to one of four dietary groups, each prescribed a specific grain food composition. The study aims to evaluate impacts on appetite, food intake, body weight, blood pressure, and blood sugar levels, while also examining changes in the microbiome. The trial controls for added sugars, saturated fats, and sodium to isolate the effects of grain consumption.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 60 with a hemoglobin A1c between 5.7 and 6.4% and a low intake of whole grain foods.
Not a fit: Patients with grain or dairy allergies, smokers, or those planning significant lifestyle changes during the study may not benefit.
Why it matters
Potential benefit: If successful, this study could provide insights into how different grain diets affect overall health and metabolic outcomes in adults.
How similar studies have performed: Previous studies have shown promising results regarding the health benefits of whole grains, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
West Lafayette, Indiana
- Purdue University — West Lafayette, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Richard Mattes, PhD — Purdue University
- Study coordinator: Judy George, BS
- Email: georgej@purdue.edu
- Phone: 4654946192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.