The Impact of a Daily Dietary Supplement on Glycemic Control in Individuals With Overweight or Obesity

September 17, 2026 updated by: Landon Deru, University of South Alabama

This clinical trial will evaluate the efficacy of Metabolic Master Pack over a 90-day intervention period. Sixty adults will be randomized to receive either Metabolic Master Pack or placebo. Participants will wear continuous glucose monitors throughout the study, complete repeated blood collections, undergo DEXA body composition assessments, and complete dietary records. Results will provide high-quality evidence regarding the product's effects on glucose regulation and metabolic health.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will enroll in this randomized, double-blind, placebo-controlled, parallel-group trial in which they will consume the assigned intervention daily, 15 minutes before their largest meal. Continuous glucose monitoring will be used to characterize glucose responses under real-world conditions. Repeated blood draws will quantify changes in metabolic hormones and inflammatory biomarkers during three distinct standardized meal tests. These tests will take place at baseline, 45 days, and 90 days of supplementation. DEXA scans and anthropometric measurements, such as waist circumfrance, will assess body composition changes. Dietary recalls will be collected to evaluate behavioral changes and dietary adherence. Activity monitors will be used to assess physical activity and sleep patterns.

Assessments:

Visit 1 (Baseline) - morning visit

  • Informed consent
  • DEXA scan (fasted)
  • Waist and hip circumference
  • Placement of CGM #1

Visit 2 (Day 2) - morning visit

  • Fasted Standardized meal test
  • Pre-test blood draw, 30 minutes post blood draw, 1 hour post blood draw
  • During the resting/waiting period:
  • Give activity tracker and orient to dietary tracking. Ensure CGM functionality.

Visit 3 (Day 15)

  • Check symptoms and adverse events
  • Replace glucose monitor
  • Dietary tracking and physical activity education

Visit 4 (Day 30)

  • Check symptoms and adverse events
  • Replace glucose monitor
  • Dietary tracking and physical activity education

Visit 5 (Day 45- halfway point)

  • Fasted standardized meal and blood draws
  • Check symptoms and adverse events
  • Replace glucose monitor
  • Dietary tracking and physical activity education

Visit 6 (Day 60)

  • Check symptoms and adverse events
  • Replace glucose monitor
  • Dietary tracking and physical activity education

Visit 7 (Day 75)

  • Check symptoms and adverse events
  • Replace glucose monitor
  • Dietary tracking and physical activity education

Visit 8 (Day 90)

  • Fasted standardized meal and blood draws
  • Waist and hip circumference measurements
  • DEXA scan
  • Collect equipment and supplies back from participant

Visit 9 (Day 91)

• CGM removal (Full 24 hr after intervention)

STATISTICAL ANALYSIS PLAN

Primary Outcome:

Change in acute fasted glucose AUC at baseline, Day 45 and Day 90.

Primary Analysis:

Mixed-effects linear model with:

  • Fixed effects: group, time, group × time
  • Random effect: participant

Secondary Analyses:

  • Repeated-measures mixed models for hormones
  • Repeated-measures mixed models for body composition
  • ANCOVA models controlling for baseline values
  • Sensitivity analyses for dietary intake and adherence
  • Physical Activity data as a covariate with glucose data

Power Analysis:

Assuming an effect size of d=0.60, alpha=0.05, and 80% power, 52 participants are required. Enrollment of 60 participants allows for approximately 15% attrition.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 25-40 kg/m²
  • Ability to provide informed consent

Exclusion Criteria:

  • Taking medications that impact metabolism
  • Report sustained weight loss of >3% in the past 3 months.
  • History of metabolic/bariatric surgery.
  • Females who are pregnant, have been pregnant within the past 6 months, or plan to become pregnant during the study period.
  • Report a current medical condition or treatment for a medical condition that could affect body weight or contradict engagement in any aspect of the outcome measures or interventions.
  • Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction or history of cardiomyopathy, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e., recent or recurrent DVT).
  • Resting systolic blood pressure of >160 mmHg or resting diastolic blood pressure of >100 mmHg. If medicated for blood pressure control, the medication dose needs to be stable for >6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supplement

This group receives the supplement for 90 days
Dietary supplement: natural glycemic control supplement

This trial will test the effectiveness of these unique compounds to improve postprandial glycemic excursion. This includes both long-term and acute control.
Placebo Comparator: Placebo

This group receives the placebo for 90 days
Dietary supplement: Placebo Multivitamin

This group will receive 90 days of a multivitamin placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interstitial Glucose
Time Frame: Continuous glucose monitoring will take place over the course of the 90 day intervention

continuous glucose monitoring
Continuous glucose monitoring will take place over the course of the 90 day intervention
Blood Biomarkers
Time Frame: Baseline (prior to any supplementation), then on day 45 of supplementation and on day 90 of supplementation. Each blood draw will be taken in the morning after an overnight fast and again 30 and 60 minutes after a standardized meal is consumed.

Insulin, Glucagon, GLP-1, Ghrelin, Leptin, and other metabolic biomarkers will be analyzed as part of an acute mixed-meal tolerance test.
Baseline (prior to any supplementation), then on day 45 of supplementation and on day 90 of supplementation. Each blood draw will be taken in the morning after an overnight fast and again 30 and 60 minutes after a standardized meal is consumed.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition
Time Frame: Baseline and at the end of the intervention

Dual-energy X-ray Absorptiometry (DEXA) for assessment of body fat percentage, lean mass, and bone density.
Baseline and at the end of the intervention
Dietary Patterns
Time Frame: 5 dietary recalls over the 90 day intervention.

Random 24-hour dietary recall to assess changes in dietary patterns over the 90-day intervention.
5 dietary recalls over the 90 day intervention.
Participant Height
Time Frame: At the baseline visit

Height to the nearest tenth of a centimeter will be recorded using a standard wall-mounted sadometer
At the baseline visit
Participant mass
Time Frame: Baseline, Day 45 of intervention and day 90 of intervention

Participant mass will be measured using a standard scientific weight scale and recorded to the nearest tenth of a kilogram.
Baseline, Day 45 of intervention and day 90 of intervention
Waist circumfrence
Time Frame: Baseline and at 45 days and 90 days of intervention.

Participants' waist circumferences will be measured using a standard flexible PVC measuring tape around the umbilicus and at the level of the iliac crest.
Baseline and at 45 days and 90 days of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Alabama

Collaborators

HLTH Code, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 9, 2026

First Submitted That Met QC Criteria

September 17, 2026

First Posted (Actual)

September 24, 2026

Study Record Updates

Last Update Posted (Actual)

September 24, 2026

Last Update Submitted That Met QC Criteria

September 17, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TBD-IRB in Progress

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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