Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity

Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06215196

Acronym

ESSENCE

Enrollment

Registered

2024-01-22

Start date

2023-04-14

Completion date

2023-08-20

Last updated

2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

Semaglutide, Weight Loss, Obesity, Appetite Suppression

Brief 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 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.

Interventions

DIETARY_SUPPLEMENTFiber Supplement Group

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.

OTHERplacebo

Semaglutide (2.4 mg weekly). Three daily packets of placebo powder, taken 30 minutes before each main meal.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* BMI ≥30, or ≥27 with comorbidities.

Exclusion criteria

* Serious chronic illnesses. * History of bulimia or anorexia. * Pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
Percentage change in body weight from baseline	180 days
Achievement of a reduction in body weight of 5% or more from baseline.	180 days

Secondary

Measure	Time frame	Description
Safety evaluated by recording any adverse events.	180 days	—
fat-free mass change	180 days	fat-free mass change assessed using bioelectrical impedance analysis
fat mass change	180 day	fat mass change assessed using bioelectrical impedance analysis
total body water change	180 days	total body water change assessed using bioelectrical impedance analysis
visceral fat rating change	180 days	visceral fat rating change assessed using bioelectrical impedance analysis
BMI change	180 days	—

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026