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Glycemic ControlNCT07837817

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

A study of Glycemic Control and Appetite Regulation, run by University of South Alabama.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Glycemic Control, Appetite Regulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
No sites listed yet
Study dates
Oct 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Landon Deru, PhD contact

251-341-3849

deru@southalabama.edu

About this study

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.

Read the 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.

Being tested
natural glycemic control supplement, Placebo Multivitamin
Keywords
glycemic control, supplement, postprandial, continuous glucose monitoring, standardized meals

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • natural glycemic control supplementDietary 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 MultivitaminDietary supplement

    This group will receive 90 days of a multivitamin placebo.

Study groups in NCT07837817
Study groupRoleWhat they receive
SupplementExperimentalThis group receives the supplement for 90 days
Receives: Dietary Supplement: natural glycemic control supplement
PlaceboPlacebo comparatorThis group receives the placebo for 90 days
Receives: Dietary Supplement: Placebo Multivitamin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Interstitial Glucose

    continuous glucose monitoring

    Measured: Continuous glucose monitoring will take place over the course of the 90 day intervention

  2. Blood Biomarkers

    Insulin, Glucagon, GLP-1, Ghrelin, Leptin, and other metabolic biomarkers will be analyzed as part of an acute mixed-meal tolerance test.

    Measured: 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 outcomes (5)

  1. Body Composition

    Dual-energy X-ray Absorptiometry (DEXA) for assessment of body fat percentage, lean mass, and bone density.

    Measured: Baseline and at the end of the intervention

  2. Dietary Patterns

    Random 24-hour dietary recall to assess changes in dietary patterns over the 90-day intervention.

    Measured: 5 dietary recalls over the 90 day intervention.

  3. Participant Height

    Height to the nearest tenth of a centimeter will be recorded using a standard wall-mounted sadometer

    Measured: At the baseline visit

  4. Participant mass

    Participant mass will be measured using a standard scientific weight scale and recorded to the nearest tenth of a kilogram.

    Measured: Baseline, Day 45 of intervention and day 90 of intervention

  5. Waist circumfrence

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

    Measured: Baseline and at 45 days and 90 days of intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, double-blind, placebo-controlled clinical trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07837817
Sponsor's protocol ID
TBD-IRB in Progress
Status last verified
Sep 2026
First submitted
9 Sep 2026
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study of Glycemic Control and Appetite Regulation, run by University of South Alabama.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Landon Deru, PhD (251-341-3849, deru@southalabama.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interstitial Glucose (time frame: Continuous glucose monitoring will take place over the course of the 90 day intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07837817.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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