Overweight and ObesityNCT07152470
An Open Label 100 Person Study Evaluating a Natural Supplement for Weight Loss and Fat Loss.
An observational study of Overweight and Obesity, run by Prostasis, LLC, dba Tonum Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Diet and Exercise Tracking
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2025to 26 Dec 2025
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: 100 patients in the United states
Who may be able to join
- BMI >25
- Willing to complete daily diary and weekly weigh-ins
- Willing to take motus daily
Who cannot join
- BMI<25
- Unwilling to complete daily diary and weekly weigh-ins
- Currently taking a prescribed weight loss medication
- Currently or planning to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label 100 Person Study Evaluating a Natural Supplement for Weight Loss and Fat Loss in a Real World Setting.
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
Read the 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
- Being tested
- Diet and Exercise Tracking
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and Exercise TrackingBehavioural
To determine if diet and/or exercise had any impact on weight loss while taking motus.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Diet and Exercise Tracking | |
| 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 Receives: Behavioral: Diet and Exercise Tracking | |
| 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 Receives: Behavioral: Diet and Exercise Tracking | |
| 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 Receives: Behavioral: Diet and Exercise Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Weight Loss
Total weight loss as a percentage of total body weight
Measured: 26 weeks
Body Fat Loss
Total body fat loss compared to lean mass loss
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start26 Jan 2025
- Primary completion26 Jul 2025
- Study completion26 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prostasis, LLC, dba Tonum Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152470
- Sponsor's protocol ID
- Motus1001
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label 100 Person Study Evaluating a Natural Supplement for Weight Loss and Fat Loss in a Real World Setting.
- ClinicalTrials.gov ID
- NCT07152470
- Acronym / sponsor ID
- Motus1001
- Conditions
- Overweight and Obesity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Prostasis, LLC, dba Tonum HealthIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2025 (actual)
- Primary completion
- 26 Jul 2025 (actual)
- Study completion
- 26 Dec 2025 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Diet with Daily Exercise (>4 days per week) | – | Behavioral: Diet and Exercise TrackingParticipants 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 |
| Average Diet with Moderate Exercise (2-3 days per week) | – | Behavioral: Diet and Exercise TrackingParticipants 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 |
| Average Diet with No Exercise (0 days per week) | – | Behavioral: Diet and Exercise TrackingParticipants 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 |
| Poor Diet with No Exercise (0 days per week) | – | Behavioral: Diet and Exercise TrackingParticipants 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 100 patients in the United states
Key inclusion criteria (3 listed)
- BMI >25
- Willing to complete daily diary and weekly weigh-ins
- Willing to take motus daily
Key exclusion criteria (4 listed)
- BMI<25
- Unwilling to complete daily diary and weekly weigh-ins
- Currently taking a prescribed weight loss medication
- Currently or planning to be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet and Exercise TrackingTo determine if diet and/or exercise had any impact on weight loss while taking motus. | Behavioural | Average Diet with Moderate Exercise (2-3 days per week), Average Diet with No Exercise (0 days per week), Healthy Diet with Daily Exercise (>4 days per week), Poor Diet with No Exercise (0 days per week) |
Primary outcome
Total Weight Loss
Time frame: 26 weeks
Total weight loss as a percentage of total body weight
Body Fat Loss
Time frame: 26 weeks
Total body fat loss compared to lean mass loss
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Prostasis, LLC, dba Tonum Health at 1 site in United States.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Weight Loss (time frame: 26 weeks). 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?
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 9 Sep 2025.