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

Arizona State University46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Hyperglycemia Obesity Prevention

Interventions

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Glucose response between two breakfasts

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.

Time frame: the entire 2 hours of the glycemic test

Insulin responses between the two breakfasts

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.

Time frame: The entire 2 hours period

Glucose réponses during glucose challenge test

Positive integer of the area under the curve for glucose during the 2 hours glycemic test

Time frame: 2 hours post ingestion of the emperimental meal (cereal or ceral + shake)

Insulin responses during the glucemic challenge test

Positive integer of the area under the curve for insulin during the 2-hours glycemic test

Time frame: 2 hour post ingestion of the intervention meal (cereal or cereal + shake)

Secondary Outcomes

Ambulatory glucose profile

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.

Time frame: total area under the curve during the 2 weeks (14 days) of dietary intervention.

Blood glucagon

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)