Research on Probiotics in Improving Obesity

NCT06964919 | Completed

• 1 other identifier: WK20250421
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the effects of Akkermansia muciniphila Akk11 heat - killed bacteria capsules compared to a placebo on body composition indicators (weight, BMI, body fat rate, waist - hip ratio (WC), wrist circumference, visceral fat area, basal metabolic rate) and blood lipid concentrations (total cholesterol (TC), low - density lipoprotein (LDL), high - density lipoprotein (HDL), triglycerides (TG)) in overweight/obese adults.

Conditions

Obesity

Outcome Measures

Primary Outcomes (10)

• Change in body weight before and after intervention

  Measured using a calibrated scale

  Week 0 , Week 4, Week 8, Week 12

• Change in BMI before and after intervention

  Measured using a calibrated scale and stadiometer

  Week 0 , Week 4, Week 8, Week 12

• Change in waist-hip ratio (WC) before and after intervention

  Measured using a non-elastic measuring tape

  Week 0 , Week 4, Week 8, Week 12

• Change in wrist circumference before and after intervention

  Measured using a non-elastic measuring tape

  Week 0 , Week 4, Week 8, Week 12

• Change in visceral fat area before and after intervention.

  Measured using bioelectrical impedance analysis (BIA)

  Week 0 , Week 4, Week 8, Week 12

• Change in basal metabolic rate (BMR) before and after intervention

  Measured using indirect calorimetry

  Week 0 , Week 4, Week 8, Week 12

• Change in serum total cholesterol (TC) concentration before and after intervention

  Detected by enzyme-linked immunosorbent assay (ELISA)

  Week 0 and Week 12

• Change in low-density lipoprotein (LDL) concentration before and after intervention

  Detected by enzyme-linked immunosorbent assay (ELISA)

  Week 0 and Week 12

• Change in high-density lipoprotein (HDL) concentration before and after intervention

  Detected by enzyme-linked immunosorbent assay (ELISA)

  Week 0 and Week 12

• Change in triglyceride (TG) concentration before and after intervention.

  Detected by enzyme-linked immunosorbent assay (ELISA)

  Week 0 and Week 12

Study Arms (2)

Probiotic group

EXPERIMENTAL

Pasteurized Akkermansia muciniphila Akk11 capsule, 10 billion TFU/day

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

Placebo capsule, one capsules/day

Dietary Supplement: Placebo

Interventions

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)

Probiotic group

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)

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A body mass index (BMI) of ≥24 kg/m²;
• Willingness to provide written informed consent to participate in the study;
• Agreement to adhere to the study protocol and restrictions, including a low-carbohydrate, energy-restricted diet;
• No plans for conception from 14 days before screening until 6 months after the trial, with a commitment to using effective contraception.

You may not qualify if:

• Use of products similar to the test product in the near term that may affect the results;
• Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergies;
• Pregnant, breastfeeding, or planning pregnancy;
• Irritable Bowel Syndrome (IBS), Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus;
• Antibiotic use within the past three months;
• Failure to consume the test product as required or attend follow-ups on time, making efficacy assessment impossible;
• Smoking more than 10 cigarettes a day;
• Allergy to probiotic products;
• Other participants deemed unsuitable for the study by the investigator.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

The School of Food and Bioengineering, Henan University of Science and Technolog

Luoyang, Henan, 471000, China

Location

MeSH Terms

Conditions

Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 11, 2025
• Study Start: March 10, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 20, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

CN (1)