The Impact of Low Glycemic Index Nutritional Shake on Glucose Regulation in Overweight and Obese Adults

Not Applicable

Recruiting

• Conditions: Hyperglycemia; Obesity Prevention

• Registration Number: NCT06856460
• Lead Sponsor: Arizona State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-28
• Status Verified: 2025-03
• Study Start: 2025-03-14
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glucose response between two breakfasts	the entire 2 hours of the glycemic test	The difference between the two breakfasts on the positive integer of the area under the curve for glucose during the 2 hours following breakfast ingestion.
Insulin responses between the two breakfasts	The entire 2 hours period	The difference between the two breakfasts on the positive integer of the area under the curve for insulin; during the 2 hours following breakfast ingestion.
Glucose réponses during glucose challenge test	2 hours post ingestion of the emperimental meal (cereal or ceral + shake)	Positive integer of the area under the curve for glucose during the 2 hours glycemic test
Insulin responses during the glucemic challenge test	2 hour post ingestion of the intervention meal (cereal or cereal + shake)	Positive integer of the area under the curve for insulin during the 2-hours glycemic test

Secondary Outcome Measures

Name	Time	Method
C-Peptide	0, 30, 60, 90, and 120 minutes of the glycemic test.	Blood c-peptide difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)
Ambulatory glucose profile	total area under the curve during the 2 weeks (14 days) of dietary intervention.	The difference between the two groups on the area under the curve in Ambulatory glucose measured with a continuous glucose monitor during the 2 weeks of dietary intervention.
Blood glucagon	0, 30, 60, 90, and 120 minutes of the glycemic test.	Blood glucagon difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)
Glucagon like peptide 1	0, 30, 60, 90, and 120 minutes of the glycemic test.	Blood Glucagon like peptide difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)
Leptin	0, 30, 60, 90, and 120 minutes of the glycemic test.	Blood Leptin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)
Adiponectin	0, 30, 60, 90, and 120 minutes of the glycemic test.	Blood Adiponectin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)
Ghrelin	0, 30, 60, 90, and 120 minutes of the glycemic test.	Blood Ghrelin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)

Trial Locations

Locations (1)

Arizona State University 850 PBC; 🇺🇸 Phoenix, Arizona, United States