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

NCT06856460 | Completed

• 1 other identifier: STUDY00016899
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity Prevention; Hyperglycemia

Keywords

meal replacement; glucose regulation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Ambulatory glucose profile

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

• Blood glucagon

  0, 30, 60, 90, and 120 minutes of the glycemic test.

• Glucagon like peptide 1

  0, 30, 60, 90, and 120 minutes of the glycemic test.

• Leptin

  0, 30, 60, 90, and 120 minutes of the glycemic test.

• Adiponectin

  0, 30, 60, 90, and 120 minutes of the glycemic test.

Study Arms (2)

Control: Breakfast with 400 kcal of oat cereal with honey

SHAM COMPARATOR

Dietary Supplement: Ceral Breakfast

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

EXPERIMENTAL

Dietary Supplement: powder shake with very low glycemic index

Interventions

Ceral Breakfast DIETARY_SUPPLEMENT

consume of 400kcal of oat-based cereal with honey for breakfast

Control: Breakfast with 400 kcal of oat cereal with honey

powder shake with very low glycemic index DIETARY_SUPPLEMENT

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.

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

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University 850 PBC

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Assistant Dean

Model Details: 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)

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 4, 2025
• Study Start: March 18, 2025
• Primary Completion: November 14, 2025
• Study Completion: February 9, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)