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.
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
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.
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.
- Conditions
- Glycemic Control, Appetite Regulation
- 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 group | Role | What they receive |
|---|---|---|
| Supplement | Experimental | This group receives the supplement for 90 days Receives: Dietary Supplement: natural glycemic control supplement |
| Placebo | Placebo comparator | This 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.
Interstitial Glucose
continuous glucose monitoring
Measured: Continuous glucose monitoring will take place over the course of the 90 day intervention
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)
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
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.
Participant Height
Height to the nearest tenth of a centimeter will be recorded using a standard wall-mounted sadometer
Measured: At the baseline visit
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
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.
- First posted24 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Collaborators
- HLTH Code, LLC
- Responsible party
- Principal investigator, Landon Deru, University of South Alabama
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