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

NCT ID: NCT06856460

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-14

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperglycemia Obesity Prevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control: Breakfast with 400 kcal of oat cereal with honey

Group Type SHAM_COMPARATOR

Ceral Breakfast

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type EXPERIMENTAL

powder shake with very low glycemic index

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

Ceral Breakfast

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Arizona State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stavros Kavouras

Professor and Assistant Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arizona State University 850 PBC

Phoenix, Arizona, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alicia Nguyen

Role: CONTACT

480-447-4811

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00016899

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Metabolic Syndrome and Functional Food
NCT00916175 COMPLETED PHASE2/PHASE3
Glycaemic Response Testing
NCT01536847 COMPLETED NA
The Breakfast Study
NCT00593307 COMPLETED NA
Glycemic Response Testing
NCT01536860 COMPLETED NA