Clinical trial NCT06856460: The Impact of Low Glycemic Index Nutritional Shake on Glucose Regulation in Overweight and Obese Adults
Official title: The Impact of Low Glycemic Index Nutritional Shake on Glucose Regulation in Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperglycemia
Obesity Prevention
Keywords: meal replacement
glucose regulation
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms: one group will undergo 2 weeks of a meal replacement shake for breakfast with oat cereal and the other group will consume only oat cereal (isocaloric 400 kilocarolies)
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Glucose response between two breakfasts
timeFrame: the entire 2 hours of the glycemic test
measure: Insulin responses between the two breakfasts
timeFrame: The entire 2 hours period
measure: Glucose réponses during glucose challenge test
timeFrame: 2 hours post ingestion of the emperimental meal (cereal or ceral + shake)
measure: Insulin responses during the glucemic challenge test
timeFrame: 2 hour post ingestion of the intervention meal (cereal or cereal + shake)
Secondary outcomes:
measure: Ambulatory glucose profile
timeFrame: total area under the curve during the 2 weeks (14 days) of dietary intervention.
measure: Blood glucagon
timeFrame: 0, 30, 60, 90, and 120 minutes of the glycemic test.
measure: Glucagon like peptide 1
timeFrame: 0, 30, 60, 90, and 120 minutes of the glycemic test.
measure: Leptin
timeFrame: 0, 30, 60, 90, and 120 minutes of the glycemic test.
measure: Adiponectin
timeFrame: 0, 30, 60, 90, and 120 minutes of the glycemic test.
measure: Ghrelin
timeFrame: 0, 30, 60, 90, and 120 minutes of the glycemic test.
measure: C-Peptide
timeFrame: 0, 30, 60, 90, and 120 minutes of the glycemic test.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University 850 PBC
state: Arizona
Study officials:
References: