Overweight and ObesityPWR-FASTNCT06221696
Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways)
A study testing Active Fiber Supplement Group in people with Overweight and Obesity, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial summary
This randomized, double-blind, placebo-controlled trial titled "Preventing Weight Regain Post-Semaglutide Treatment with Active Fiber Supplement (Soloways)" evaluated the efficacy of an active fiber supplement in preventing weight regain post-Semaglutide treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Active Fiber Supplement Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteRussia
- Study dates
- 12 Jun 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults with a history of obesity or overweight and completed Semaglutide course.
- Age 18-65 years.-
Who cannot join
- Serious chronic illnesses.
- History of bulimia or anorexia.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, 630090
About this study
Official title: Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways): A Randomized, Placebo-Controlled, Double-Blind Clinical Trial
This randomized, double-blind, placebo-controlled trial titled "Preventing Weight Regain Post-Semaglutide Treatment with Active Fiber Supplement (Soloways)" evaluated the efficacy of an active fiber supplement in preventing weight regain post-Semaglutide treatment. Participants were adults aged 18-65, with a history of obesity or overweight, and had completed a Semaglutide course. The study involved 160 participants, equally divided into two groups: one receiving the active fiber supplement (glucomannan, inulin, and psyllium) and the other a placebo, both taken 30 minutes before each main meal for 180 days. Co-primary endpoints were the percentage of weight regain from baseline to day 180 and metabolic health markers (blood glucose levels, HbA1c, lipid profile, blood pressure). Secondary endpoints included changes in BMI, body composition, and appetite assessment using VAS ratings and the Control of Eating Questionnaire (CoEQ). Participants also adhered to a reduced-calorie diet and increased physical activity, with all standard assays performed in a central laboratory. The study's objective was to determine the supplement's effectiveness in enhancing satiety, improving digestive health, and thus better managing weight compared to a placebo
- Conditions
- Overweight and Obesity
- Being tested
- Active Fiber Supplement Group, Placebo Group
- Keywords
- Semaglutide, Dietary Fiber, Weight Loss, Appetite Suppression
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Fiber Supplement GroupDietary supplement
Three daily packets of active fiber supplement (each containing 1g of glucomannan, 1g of inulin, and 3g of psyllium), taken 30 minutes before each main meal. The supplement is provided by S.Lab (Soloways), LLC.
Placebo GroupOther
Three daily packets of placebo powder, taken 30 minutes before each main meal.
| Study group | Role | What they receive |
|---|---|---|
| Active Fiber Supplement Group | Experimental | Not described Receives: Dietary Supplement: Active Fiber Supplement Group |
| Placebo Group | Placebo comparator | Not described Receives: Other: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of weight regain from baseline
Measured: 180 days
Secondary outcomes (12)
blood glucose levels change
Measured: 180 days
blood HbA1c change
Measured: 180 days
blood total cholesterol change
Measured: 180 days
blood LDL change
Measured: 180 days
blood triglycerides change
Measured: 180 days
Systolic and diastolic blood pressure change
Measured: 180 days
BMI changes
Monitoring the changes in Body Mass Index from the baseline
Measured: 180 days
Visceral fat rating change from baseline
Measured: 180 days
fat-free mass changes
Measured: 180 days
visceral fat changes
Measured: 180 days
total body water changes
Measured: 180 days
Effect of glucomannan, inulin, and psyllium on appetite assessed using mean postprandial participant-reported visual analog score (VAS) ratings from 0 to 10 points, where 0 is appetite absence and 10 good appetite, following a standardized breakfast
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start12 Jun 2023
- Primary completion23 Nov 2023
- Study completion1 Dec 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center of New Medical Technologies, Triangel Scientific
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221696
- Sponsor's protocol ID
- SW005
- Acronym
- PWR-FAST
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways): A Randomized, Placebo-Controlled, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06221696
- Acronym / sponsor ID
- PWR-FAST / SW005
- Conditions
- Overweight and Obesity
- Keywords
- Semaglutide, Dietary Fiber, Weight Loss, Appetite Suppression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center of New Medical Technologies, Triangel Scientific
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 24 Jan 2024 (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.
This randomized, double-blind, placebo-controlled trial titled "Preventing Weight Regain Post-Semaglutide Treatment with Active Fiber Supplement (Soloways)" evaluated the efficacy of an active fiber supplement in preventing weight regain post-Semaglutide treatment. Participants were adults aged 18-65, with a history of obesity or overweight, and had completed a Semaglutide course. The study involved 160 participants, equally divided into two groups: one receiving the active fiber supplement (glucomannan, inulin, and psyllium) and the other a placebo, both taken 30 minutes before each main meal for 180 days. Co-primary endpoints were the percentage of weight regain from baseline to day 180 and metabolic health markers (blood glucose levels, HbA1c, lipid profile, blood pressure). Secondary endpoints included changes in BMI, body composition, and appetite assessment using VAS ratings and the Control of Eating Questionnaire (CoEQ). Participants also adhered to a reduced-calorie diet and increased physical activity, with all standard assays performed in a central laboratory. The study's objective was to determine the supplement's effectiveness in enhancing satiety, improving digestive health, and thus better managing weight compared to a placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Fiber Supplement Group | Experimental | Dietary Supplement: Active Fiber Supplement Group |
| Placebo Group | Placebo comparator | Other: Placebo Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with a history of obesity or overweight and completed Semaglutide course.
- Age 18-65 years.-
Key exclusion criteria (3 listed)
- Serious chronic illnesses.
- History of bulimia or anorexia.
- Pregnancy or lactation.
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 |
|---|---|---|
| Active Fiber Supplement GroupThree daily packets of active fiber supplement (each containing 1g of glucomannan, 1g of inulin, and 3g of psyllium), taken 30 minutes before each main meal. The supplement is provided by S.Lab (Soloways), LLC. | Dietary supplement | Active Fiber Supplement Group |
| Placebo GroupThree daily packets of placebo powder, taken 30 minutes before each main meal. | Other | Placebo Group |
Primary outcome
Percentage of weight regain from baseline
Time frame: 180 days
12 secondary outcomes
blood glucose levels change
Time frame: 180 days
blood HbA1c change
Time frame: 180 days
blood total cholesterol change
Time frame: 180 days
blood LDL change
Time frame: 180 days
blood triglycerides change
Time frame: 180 days
Systolic and diastolic blood pressure change
Time frame: 180 days
BMI changes
Time frame: 180 days
Visceral fat rating change from baseline
Time frame: 180 days
fat-free mass changes
Time frame: 180 days
visceral fat changes
Time frame: 180 days
total body water changes
Time frame: 180 days
Effect of glucomannan, inulin, and psyllium on appetite assessed using mean postprandial participant-reported visual analog score (VAS) ratings from 0 to 10 points, where 0 is appetite absence and 10 good appetite, following a standardized breakfast
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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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?
A study testing Active Fiber Supplement Group in people with Overweight and Obesity, run by S.LAB (SOLOWAYS) at 1 site in Russia.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 13 Feb 2024. 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 Russia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of weight regain from baseline (time frame: 180 days). 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 13 Feb 2024.