Overweight and ObesityESSENCENCT06215196
Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity
A study testing Fiber Supplement Group in people with Overweight and Obesity, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial summary
This clinical trial investigated the combined effects of Semaglutide and a fiber supplement (glucomannan, inulin, psyllium) on weight loss in adults with overweight or obesity. Participants, aged 18-65 with a BMI ≥30 or ≥27 with comorbidities, were randomized into two groups: one receiving Semaglutide with active… 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?
- Fiber Supplement Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteRussia
- Study dates
- 14 Apr 2023to 20 Aug 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
- BMI ≥30, or ≥27 with comorbidities.
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: Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial
This clinical trial investigated the combined effects of Semaglutide and a fiber supplement (glucomannan, inulin, psyllium) on weight loss in adults with overweight or obesity. Participants, aged 18-65 with a BMI ≥30 or ≥27 with comorbidities, were randomized into two groups: one receiving Semaglutide with active fiber supplements and the other with Semaglutide and placebo, over a 180-day period. Key endpoints included percentage change in body weight, BMI, body composition, safety, and appetite control, with a focus on evaluating the additive effects of dietary fibers in enhancing Semaglutide's efficacy.
- Conditions
- Overweight and Obesity
- Being tested
- Fiber Supplement Group, placebo
- Keywords
- Semaglutide, Weight Loss, Obesity, 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.
Fiber Supplement GroupDietary supplement
Semaglutide (2.4 mg weekly). 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.
placeboOther
Semaglutide (2.4 mg weekly). Three daily packets of placebo powder, taken 30 minutes before each main meal.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide with Active Fiber Supplement Group | Experimental | Not described Receives: Dietary Supplement: Fiber Supplement Group |
| Placebo group | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight from baseline
Measured: 180 days
Achievement of a reduction in body weight of 5% or more from baseline.
Measured: 180 days
Secondary outcomes (6)
BMI change
Measured: 180 days
fat mass change
fat mass change assessed using bioelectrical impedance analysis
Measured: 180 day
Safety evaluated by recording any adverse events.
Measured: 180 days
fat-free mass change
fat-free mass change assessed using bioelectrical impedance analysis
Measured: 180 days
visceral fat rating change
visceral fat rating change assessed using bioelectrical impedance analysis
Measured: 180 days
total body water change
total body water change assessed using bioelectrical impedance analysis
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 posted22 Jan 2024
- Study start14 Apr 2023
- Primary completion28 Jun 2023
- Study completion20 Aug 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
- 81 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
- NCT06215196
- Sponsor's protocol ID
- SW004
- Acronym
- ESSENCE
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 23 Jan 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 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06215196
- Acronym / sponsor ID
- ESSENCE / SW004
- Conditions
- Overweight and Obesity
- Keywords
- Semaglutide, Weight Loss, Obesity, Appetite Suppression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center of New Medical Technologies, Triangel Scientific
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 22 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 clinical trial investigated the combined effects of Semaglutide and a fiber supplement (glucomannan, inulin, psyllium) on weight loss in adults with overweight or obesity. Participants, aged 18-65 with a BMI ≥30 or ≥27 with comorbidities, were randomized into two groups: one receiving Semaglutide with active fiber supplements and the other with Semaglutide and placebo, over a 180-day period. Key endpoints included percentage change in body weight, BMI, body composition, safety, and appetite control, with a focus on evaluating the additive effects of dietary fibers in enhancing Semaglutide's efficacy.
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 |
|---|---|---|
| Semaglutide with Active Fiber Supplement Group | Experimental | Dietary Supplement: Fiber Supplement Group |
| Placebo group | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI ≥30, or ≥27 with comorbidities.
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 |
|---|---|---|
| Fiber Supplement GroupSemaglutide (2.4 mg weekly). 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. | Dietary supplement | Semaglutide with Active Fiber Supplement Group |
| placeboSemaglutide (2.4 mg weekly). Three daily packets of placebo powder, taken 30 minutes before each main meal. | Other | Placebo group |
Primary outcome
Percentage change in body weight from baseline
Time frame: 180 days
Achievement of a reduction in body weight of 5% or more from baseline.
Time frame: 180 days
6 secondary outcomes
BMI change
Time frame: 180 days
fat mass change
Time frame: 180 day
Safety evaluated by recording any adverse events.
Time frame: 180 days
fat-free mass change
Time frame: 180 days
visceral fat rating change
Time frame: 180 days
total body water change
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 23 Jan 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 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 1 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 23 Jan 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 change in body weight from baseline (time frame: 180 days). 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 23 Jan 2024.