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

Arizona State University (ASU)

Status: Enrolling

Conditions: Obesity Prevention; Hyperglycemia

Treatments: Dietary Supplement: Ceral Breakfast; Dietary Supplement: powder shake with very low glycemic index

Study type: Interventional

Funder types: Other

Identifiers

NCT06856460

STUDY00016899

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control: Breakfast with 400 kcal of oat cereal with honey

Sham Comparator group

Treatment:

Dietary Supplement: Ceral Breakfast

Experimental: Breakfast with 200 kcal of oat ceral with honey + 200 kcal of glucose assist shake.

Experimental group

Treatment:

Dietary Supplement: powder shake with very low glycemic index