Probiotic for Weight Management in Overweight and Obese Adults

ConditionObesity

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorWecare Probiotics Co., Ltd.

About this trial

To evaluate the impact of pasteurized Akkermansia muciniphila Akk11 capsules versus placebo on body composition (including body weight, BMI, body fat percentage, waist-to-hip ratio, wrist circumference, visceral fat area, and basal metabolic rate) and serum lipid parameters (TC, LDL-C, HDL-C, and TG) in overweight and obese adults.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body mass index (BMI) ≥ 24 kg/m²;

Able and willing to provide written informed consent;

Willing to comply with the study protocol and required restrictions, including adherence to a low-carbohydrate, energy-restricted diet;

No intention to conceive from 14 days prior to screening until 6 months after study completion, and agreement to use effective contraception during this period

Disqualifiers

Recent use of products with similar functions to the investigational product that may interfere with study outcomes;

History of psychiatric or neurological disorders, celiac disease, lactose intolerance, or known allergies;

Pregnant or breastfeeding women, or those planning to become pregnant during the study period;

Diagnosis of irritable bowel syndrome (IBS), ulcerative colitis, liver cirrhosis, or diabetes mellitus;

Trial design

Design model

Parallel

Treatments tested in this trial

Probiotic
Dietary supplement
The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12)
Placebo
Dietary supplement
The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12)

Treatment groups

76 Participants

are divided into 2 treatment groups

Group A: Probiotic groupExperimental treatment 1 intervention

Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change from baseline in body weight following the intervention

Body weight will be assessed using a calibrated digital scale under standardized conditions

Time frame

Baseline (Week 0) and Weeks 4, 8, and 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wecare Probiotics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: