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Completed

NCT Number: NCT06215196

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

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.

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Key information

Conditions

Overweight and Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI ≥30, or ≥27 with comorbidities.

Exclusion criteria

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

Treatment and study plan

Fiber Supplement Group

Dietary 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.

Placebo

Other

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

Primary outcomes

  1. Percentage change in body weight from baseline

    Time frame: 180 days

  2. Achievement of a reduction in body weight of 5% or more from baseline.

    Time frame: 180 days

Secondary outcomes

  1. BMI change

    Time frame: 180 days

  2. fat mass change

    Time frame: 180 day

    fat mass change assessed using bioelectrical impedance analysis

  3. Safety evaluated by recording any adverse events.

    Time frame: 180 days

  4. fat-free mass change

    Time frame: 180 days

    fat-free mass change assessed using bioelectrical impedance analysis

  5. visceral fat rating change

    Time frame: 180 days

    visceral fat rating change assessed using bioelectrical impedance analysis

  6. total body water change

    Time frame: 180 days

    total body water change assessed using bioelectrical impedance analysis

Sponsors and collaborators

Lead sponsor

S.LAB (SOLOWAYS)

Other

Collaborators

  • Center of New Medical Technologies
  • Triangel Scientific

Registry information

Official study 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

Acronym: ESSENCE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2024
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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