NCT06221696

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
Last Updated

February 13, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 15, 2024

Last Update Submit

February 9, 2024

Conditions

Overweight and Obesity

Keywords

SemaglutideDietary FiberWeight LossAppetite Suppression

Outcome Measures

Primary Outcomes (1)

  • Percentage of weight regain from baseline

    180 days

Secondary Outcomes (12)

  • blood glucose levels change

    180 days

  • blood HbA1c change

    180 days

  • blood total cholesterol change

    180 days

  • blood LDL change

    180 days

  • blood triglycerides change

    180 days

  • +7 more secondary outcomes

Other Outcomes (2)

  • Fasting and mean postprandial changes in visual analog score (VAS) ratings from 0 to 10 points for thirst, nausea, and well-being following a standardized breakfast.

    180 days

  • Participant-reported control of eating evaluated using the Control of Eating Questionnaire (CoEQ) with 20 questions containing 5 oprions where 1 means the best and 5 the worst outcome

    180 days

Study Arms (2)

Active Fiber Supplement Group

EXPERIMENTAL
Dietary Supplement: Active Fiber Supplement Group

Placebo Group

PLACEBO COMPARATOR
Other: Placebo Group

Interventions

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.

Active Fiber Supplement Group
Placebo GroupOTHER

Three daily packets of placebo powder, taken 30 minutes before each main meal.

Placebo Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with a history of obesity or overweight and completed Semaglutide course.
  • Age 18-65 years.-

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Location

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2024

First Posted

January 24, 2024

Study Start

June 12, 2023

Primary Completion

November 23, 2023

Study Completion

December 1, 2023

Last Updated

February 13, 2024

Record last verified: 2024-01

Locations

RU(1)