The Impact of Low Glycemic Index Nutritional Shake on Glucose Regulation in Overweight and Obese … (NCT06856460) | Clinical Trial Compass
CompletedNot Applicable
The Impact of Low Glycemic Index Nutritional Shake on Glucose Regulation in Overweight and Obese Adults
United States46 participantsStarted 2025-03-18
Plain-language summary
Low glycemic index nutritional shakes have clinically shown to improve post-prandial glycemic responses in acute laboratory control studies. However, there is limited information on how replacing meals with low-glycemic index shake could impact glucose regulation in free-living adults consuming their own diets.
The present study aims to examine the impact of adding the SP Glucose-Assist shake to the breakfast of non-diabetic overweight and obese adults.
Subjects:
40 non-diabetic adults aged 25-65 years and body mass index ranging between 25-39 .
Protocol:
This is going to be a three-week study that will include a one-week self-selected diet, followed by two weeks of a breakfast supplement shake (standard process glucose assist) or control cereal oat breakfast.
Who can participate
Age range
25 Years – 65 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:
* Body mass index 25-40
* Eating pattern 3 meals a day
* stable weight for the last 2 months (\<5 pounds fluctuation)
* Willing to eat oat cereal for breakfast
* glycated hemoglobin \<7%
Exclusion Criteria:
* glycated hemoglobin \>7%
* Body mass index ≤25 or ≥ 40
* Night shifting work
* Atypical meal pattern (not three meals a day or intermittent fasting)
* Thyroid medication
* Bariatric surgery
* Habitual strenuous exercise
* Commuting by bicycle
* Eating disorders
* Use of aspirin during the duration of the study
* Intake of Vit C \>60 mg/day during the study
* cancer
* cardiovascular disease
* renal disease
* hepatic disease
* X-ray, MRI or CT appointment during the study duration
* Current infection requiring medication
* Chronic, contagious, infectious diseases such as tuberculosis, Hepatitis A, B, C, or HIV
* Medications of supplements that could affect body weight or appetite (i.e. Ozempic)
* Participating in another study at the same time
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.
What they're measuring
1
Glucose response between two breakfasts
Timeframe: the entire 2 hours of the glycemic test
2
Insulin responses between the two breakfasts
Timeframe: The entire 2 hours period
3
Glucose réponses during glucose challenge test
Timeframe: 2 hours post ingestion of the emperimental meal (cereal or ceral + shake)
4
Insulin responses during the glucemic challenge test
Timeframe: 2 hour post ingestion of the intervention meal (cereal or cereal + shake)