Health Effects of Grain Foods in Adults (NCT06339879) | Clinical Trial Compass
RecruitingNot Applicable
Health Effects of Grain Foods in Adults
United States120 participantsStarted 2024-01-18
Plain-language 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.
Who can participate
Age range
21 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.