Study on the Weight Loss Effects and Mechanisms of Probiotic Preparation Intervention in Weight Cyclers

NCT07031596 | Not Yet Recruiting DMC

• 1 other identifier: K7816
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study Background and Purpose Obesity is a complex chronic disease closely linked to comorbidities such as cardiovascular disease, hypertension, and diabetes. With lifestyle changes, obesity prevalence continues to rise. Current treatments focus on weight loss through dietary control and exercise, but weight regain is common due to metabolic adaptations (e.g., post-caloric restriction). Gut microbiota play a critical role in weight management, and probiotics may reduce weight regain by modulating appetite and metabolism. Studies suggest probiotics enhance satiety and reduce appetite. This study aims to evaluate the potential of probiotics in obesity management, specifically their impact on gut microbiota modulation and hormonal regulation to mitigate weight regain. Ethical approval has been obtained from the Peking Union Medical College Hospital Ethics Committee.
2. 2.Study Design
3. 3.Study Procedure Informed Consent : Required before participation. Screening Phase : Demographic history, medical records, concomitant medications, validated questionnaires, body composition analysis, and blood/urine/stool tests.
4. 4.Study Completion Duration : 84 days. Post-Study : Placebo group receives 1-month free probiotic supply; others return to standard care. A 30-day post-study follow-up (phone/WeChat) will assess safety.
5. 5.Potential Benefits Personalized nutrition counseling and body composition reports. Free clinical evaluations and health coaching. Contribution to novel weight management strategies for weight-cycling populations.
6. 6.Risks and Discomforts Adverse Events : Gastrointestinal symptoms or discomfort. Immediate reporting required for medical management.

Conditions

Obesity and Obesity-related Medical Conditions

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with >5% Body Weight Loss

  Proportion of participants achieving ≥5% reduction in body weight from baseline (D0) to end of intervention (D85).

  From baseline (D0) to end of intervention (D85 ±7 days)

Secondary Outcomes (10)

• Change in Power of Food Scale (PFS) Score

  From baseline (D0) to end of intervention (D85 ±7 days)

• Change in Fasting Insulin Concentration

  From baseline (D0) to end of intervention (D85 ±7 days)

• Change in Body Weight

  From baseline (D0) to end of intervention (D85 ±7 days)

• Change in Triglyceride Concentration

  From baseline (D0) to end of intervention (D85 ±7 days)

• Change in Gut Microbial α-Diversity (Shannon Index)

  From baseline (D0) to end of intervention (D85 ±7 days)

Study Arms (3)

Probiotic Group 1

EXPERIMENTAL

Daily oral administration of Probiotic Formulation 1 (2 bottles, twice daily) for 84 days.

Dietary Supplement: WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100).

Probiotic Group 2

EXPERIMENTAL

Daily oral administration of Probiotic Formulation 2 (2 bottles, twice daily) for 84 days.

Dietary Supplement: WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100) + WONDERLAB Weight Management Probiotic Food.

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100). DIETARY_SUPPLEMENT

Product : WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100). Ingredients : Stachyose, fructooligosaccharides, isomaltooligosaccharides, maltodextrin, Lactiplantibacillus plantarum CECT7527, Lactiplantibacillus plantarum CECT7528, Lactiplantibacillus plantarum CECT7529, Lactobacillus acidophilus GOLDGUT-LA100, and Epigallocatechin gallate (EGCG). Administration : Twice daily (2 bottles per dose) after meals for 12 weeks.

Also known as: Calorie-Restricted Diet

Probiotic Group 1

WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100) + WONDERLAB Weight Management Probiotic Food. DIETARY_SUPPLEMENT

Product : WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100) + WONDERLAB Weight Management Probiotic Food. Ingredients : S100 Components : As above. Weight Management Components : Isomaltooligosaccharides, fructooligosaccharides, maltodextrin, Lactobacillus fermentum K7-Lb1, Lactobacillus fermentum K8-Lb1, Lactobacillus fermentum K11-Lb3, Euglena gracilis, and phosphatidylserine. Administration : Twice daily (2 bottles per dose) after meals for 12 weeks.

Also known as: Calorie-Restricted Diet

Probiotic Group 2

Placebo DIETARY_SUPPLEMENT

Daily oral administration of maltodextrin-based placebo (identical in taste, appearance, and packaging to probiotic products) twice daily (2 bottles per dose) for 12 weeks.

Also known as: Calorie-Restricted Diet

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Obesity : BMI ≥28 kg/m² and \<35 kg/m².
• Weight Cycling History :
• Documented weight loss attempts within the past 2 years (≥3 episodes) with ≥5% body weight fluctuation.
• Age : 18-60 years (inclusive), male or female.
• Comprehension and Voluntariness : Ability to understand the weight loss protocol and willingness to complete the full study.
• Informed Consent : Signed informed consent form.

You may not qualify if:

• Weight-Loss Medications : Current use of medications affecting weight (e.g., orlistat, GLP-1 receptor agonists, metformin).
• Diabetes Mellitus : Diagnosed diabetes or use of antidiabetic medications.
• Severe Metabolic Abnormalities :
• Triglycerides \>2.5× upper limit of normal (ULN) Cholesterol \>2.5× ULN (method-dependent) Fasting whole-blood glucose \>11.1 mmol/L Uric acid \>2× ULN
• Pregnancy/Lactation : Currently pregnant, breastfeeding, or planning pregnancy within 3 months.
• Severe Organ Dysfunction : Advanced cardiovascular, hepatic, pulmonary, renal, or other critical organic diseases.
• Thyroid Disorders : Diagnosed hyperthyroidism or hypothyroidism.
• Gastrointestinal Diseases : History of acute/chronic or active gastrointestinal disorders.
• Antibiotic Use : Oral/intravenous antibiotics within the past month.
• Psychiatric Disorders : Severe mental illness requiring routine psychiatric medication.
• Secondary Obesity : Hypothalamic obesity, Cushing's syndrome, hypogonadism-related obesity, etc.
• Specific Diets : Long-term vegan or restrictive dietary patterns.
• Weight Instability : ≥10% body weight change within the past 3 months.
• Compliance Concerns : Poor compliance or inability to adhere to the weight loss protocol (as judged by the investigator).

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Obesity

Interventions

S100 Proteins; Caloric Restriction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Calcium-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Na Yang, MD

CONTACT

86+13717712591; nayangchn@foxmail.com

Study Design

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

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 22, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)