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

Last updated: March 31, 2025
Sponsor: Arizona State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Obesity

Diabetes Mellitus Types I And Ii

Treatment

Ceral Breakfast

powder shake with very low glycemic index

Clinical Study ID

NCT06856460
STUDY00016899
  • Ages 25-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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

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, orHIV

  • Medications of supplements that could affect body weight or appetite (i.e. Ozempic)

  • Participating in another study at the same time

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Ceral Breakfast
Phase:
Study Start date:
March 14, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Arizona State University 850 PBC

    Phoenix, Arizona 85004
    United States

    Active - Recruiting

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