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

NCT ID: NCT07152470

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-26
• Study Completion Date: 2025-12-26

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).

Conditions

Overweight and Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Diet with Daily Exercise (>4 days per week)

Participants consumed a strict healthy diet and daily exercise (\>30 mins) as determined by nutritionists who were randomly assigned to participants to review their wellness tracker and conduct periodic 1:1 coaching sessions

Diet and Exercise Tracking

Intervention Type: BEHAVIORAL

To determine if diet and/or exercise had any impact on weight loss while taking motus.

Average Diet with Moderate Exercise (2-3 days per week)

Participants consumed an average diet with 2-3 days of exercise per week (\>30 mins) as determined by nutritionists who were randomly assigned to participants to review their wellness tracker and conduct periodic 1:1 coaching sessions

Diet and Exercise Tracking

Intervention Type: BEHAVIORAL

To determine if diet and/or exercise had any impact on weight loss while taking motus.

Average Diet with No Exercise (0 days per week)

Participants consumed an average diet with zero days of exercise per week as determined by nutritionists who were randomly assigned to participants to review their wellness tracker and conduct periodic 1:1 coaching sessions

Diet and Exercise Tracking

Intervention Type: BEHAVIORAL

To determine if diet and/or exercise had any impact on weight loss while taking motus.

Poor Diet with No Exercise (0 days per week)

Participants consumed a poor diet with zero days of exercise per week as determined by nutritionists who were randomly assigned to participants to review their wellness tracker and conduct periodic 1:1 coaching sessions

Diet and Exercise Tracking

Intervention Type: BEHAVIORAL

To determine if diet and/or exercise had any impact on weight loss while taking motus.

Interventions

Diet and Exercise Tracking

To determine if diet and/or exercise had any impact on weight loss while taking motus.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prostasis, LLC, dba Tonum Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tonum Health

West Palm Beach, Florida, United States

Countries

United States

Other Identifiers

Motus1001

Identifier Type: -

Identifier Source: org_study_id