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Effects of Plant-Based Caloric Restriction Diet (PB-CRD) on Weight Loss and Gut Microbiota in Obese Patients : a Randomized Clinical Trial

Effects of Plant-Based Caloric Restriction Diet (PB-CRD) on Weight Loss and Gut Microbiota in Obese Patients : a Randomized Clinical Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081330
Enrollment
Unknown
Registered
2024-02-28
Start date
2022-11-10
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesity

Interventions

plant-based calorie restriction diet group:Participants in the plant-based calorie diet group will follow a "5+2" pattern, where they will adhere to the meal plan of Miouxian's "Weight Management" mea
calorie restriction group:The calorie-restricted diet involves reducing the total energy intake by 500 to 1000 kcal per day based on the target energy intake, or reducing the total energy intake by 1/

Sponsors

Department of Endocrinology and Metabolism, Shanghai Tenth People's Hospital, School of Medicine, Tongji University, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Male and premenopausal female participants aged 18-45 years old are eligible to sign the informed consent form. 2. Participants diagnosed as obese based on a body mass index (BMI) ranging from 28 to 40 kg/m2.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of type 1 or type 2 diabetes, gestational diabetes, and some specific types of diabetes 2. Taking medications affecting weight or energy intake/energy expenditure in the last 3 months, including weight loss medications, antipsychotic drugs and glucocorticoids. 3. Underwent weight-loss surgery in the last 6 months 4. Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) 5. Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR6.0 as measured at screening) 12. Patients who took antibiotics or probiotics in the past 1 months 13. Patients who abused drugs or alcohol or suffered from severe mental disorder (major depression, schizophrenia, bipolar disorder) 14.Patients who are unwilling or unable to give informed consent

Design outcomes

Primary

MeasureTime frame
weight;

Secondary

MeasureTime frame
Gastrointestinal flora;Biochemical test;

Countries

China

Contacts

Public ContactLe Bu

the Tenth People's Hospital of Tongji University

geyingjun@hotmail.com+86 177 0162 1016

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026