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Completed

NCT Number: NCT06856460

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

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.

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Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Obesity Prevention

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University 850 PBC

Phoenix, Arizona, 85004, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Ceral Breakfast

Dietary Supplement

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

Primary outcomes

  1. Glucose response between two breakfasts

    Time frame: the entire 2 hours of the glycemic test

    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.

  2. Insulin responses between the two breakfasts

    Time frame: The entire 2 hours period

    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.

  3. Glucose réponses during glucose challenge test

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

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

  4. Insulin responses during the glucemic challenge test

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

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

Secondary outcomes

  1. Ambulatory glucose profile

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

    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.

  2. Blood glucagon

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

    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)

  3. Glucagon like peptide 1

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

    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)

  4. Leptin

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

    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)

  5. Adiponectin

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

    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)

  6. Ghrelin

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

    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)

  7. C-Peptide

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

    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)

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Acronym: SHAKE

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 4, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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