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Dietary Supplement
Dietary supplement and intermittent fasting regimen for Healthy Subjects
N/A
Waitlist Available
Led By Dawn Beckman, MD
Research Sponsored by Unicity International, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body mass index (BMI) ≥25.0 to <35.0 kg/m2
Waist circumference >102 cm for men and >88 cm for women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days
Awards & highlights
Study Summary
This trial will test the effect of a nutritional supplement and fasting regimen on blood sugar levels in people at risk for diabetes.
Eligible Conditions
- Healthy Subjects
- Prediabetes
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glycemic variability
Secondary outcome measures
Daytime and Overall Blood Glucose Levels
Daytime glycemic variability
Gastrointestinal symptoms
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2Experimental Treatment1 Intervention
A four-day period during which subjects will take a yerba mate supplement once per day in the morning and a fiber-based supplement twice per day prior to two meals, while also practicing daily intermittent fasting (16 hours fasting, 8 hours eating window).
Group II: Phase 1Experimental Treatment1 Intervention
A four-day period during which subjects will take a yerba mate supplement once per day in the morning and a fiber-based supplement twice per day prior to two meals.
Group III: BaselineActive Control1 Intervention
A baseline period (no supplements or intermittent fasting).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary supplement regimen
2022
N/A
~50
Find a Location
Who is running the clinical trial?
Unicity International, Inc.Lead Sponsor
Biofortis Innovation ServicesUNKNOWN
2 Previous Clinical Trials
144 Total Patients Enrolled
Dawn Beckman, MDPrincipal InvestigatorBiofortis Innovation Services
8 Previous Clinical Trials
435 Total Patients Enrolled
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