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

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 Overview

• Status: Completed
• Conditions: Hyperglycemia; Obesity Prevention
• Intervention / Treatment: Dietary supplement: Ceral Breakfast; Dietary supplement: powder shake with very low glycemic index

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona State University 850 PBC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control: Breakfast with 400 kcal of oat cereal with honey	Dietary supplement: Ceral Breakfast; consume of 400kcal of oat-based cereal with honey for breakfast
Experimental: Experimental: Breakfast with 200 kcal of oat ceral with honey + 200 kcal of glucose assist shake.	Dietary supplement: powder shake with very low glycemic index; 2 weeks of cereal and standard process glucose assist shake as part of breakfast. The diet for the remainder of the day will remain unchanged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	2 hour post ingestion of the intervention meal (cereal or cereal + shake)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	0, 30, 60, 90, and 120 minutes of the glycemic test.
Glucagon like peptide 1	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)	0, 30, 60, 90, and 120 minutes of the glycemic test.
Leptin	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)	0, 30, 60, 90, and 120 minutes of the glycemic test.
Adiponectin	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)	0, 30, 60, 90, and 120 minutes of the glycemic test.
Ghrelin	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)	0, 30, 60, 90, and 120 minutes of the glycemic test.
C-Peptide	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)	0, 30, 60, 90, and 120 minutes of the glycemic test.

Collaborators and Investigators

• Sponsor: Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2025
• Primary Completion (Actual): November 14, 2025
• Study Completion (Actual): February 9, 2026

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: meal replacement; glucose regulation
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: STUDY00016899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No