An Open Label 100 Person Study Evaluating a Natural Supplement for Weight Loss and Fat Loss.

Active, not recruiting

• Conditions: Overweight and Obesity

• Registration Number: NCT07152470
• Lead Sponsor: Prostasis, LLC, dba Tonum Health

Brief Summary

The goal of this clinical trial is to learn if motus, a natural supplement can support healthy weight loss and fat loss in a real world setting without caloric restrictions or exercise requirements.

The main questions it aims to answer are:

Can a daily dose of motus result in statistically significant weight loss over 3 month and 6 month time points.

Participants will:

Weigh-in at baseline and every week thereafter Take drug motus every day Complete a food tracker app for every meal and drink product consumed daily Complete an exercise tracker for any activities performed daily Complete weekly satisfaction surveys on various topics

Detailed Description

A prospective, observational human study was conducted with 100 participants (ages 25-68, BMI ≥25) over an initial 12-week period, followed by a 12-week extension phase for 40 continuing participants. All subjects received motus (4-capsule daily dose) and were instructed to track food intake and exercise via food tracker app and digital fat measurement scales. No caloric restriction was mandated, and participants could optionally receive nutritional counseling. Weekly weigh-ins and quality of life surveys were completed. No financial compensation was provided. Participants were stratified post hoc into three behavioral groups based on food and activity logs reviewed by registered dietitians: Category 1 (healthy diet + exercise 4+ times per week), Category 2 (average diet + exercise 2-3 times per week), Category 3 (average diet + no exercise) and Category 4 (poor diet + no exercise).

Study Timeline

• Study Start: 2025-01-26
• Primary Completion: 2025-07-26
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-08-26
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-09
• Study Completion: 2025-12-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• BMI >25
• Willing to complete daily diary and weekly weigh-ins
• Willing to take motus daily

Exclusion Criteria

• BMI<25
• Unwilling to complete daily diary and weekly weigh-ins
• Currently taking a prescribed weight loss medication
• Currently or planning to be pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Weight Loss	26 weeks	Total weight loss as a percentage of total body weight
Body Fat Loss	26 weeks	Total body fat loss compared to lean mass loss

Trial Locations

Locations (1)

Tonum Health; 🇺🇸 West Palm Beach, Florida, United States