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A randomized double-blind controlled trial of a probiotic pharmacologic food complex formulation to intervene in obesity

A randomized double-blind controlled trial of a probiotic pharmacologic food complex formulation to intervene in obesity

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072303
Enrollment
Unknown
Registered
2023-06-09
Start date
2023-06-10
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Obesity

Interventions

Intervention group:Use of probiotic medicinal food compound food preparation
Control group:placebo

Sponsors

Affiliated Hospital of Hangzhou Normal University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Meet the above Chinese and Western medical diagnostic criteria; (2) Any gender, age 18-60 years old; (3) Not treated with meal replacements, enzymes, diet pills, or other weight loss techniques; (4) Those who can persist in completing the trial, while strictly following the treatment cycle and cooperating with the doctor in clinical treatment and data measurement; (5) Voluntarily participate and sign the consent form.

Exclusion criteria

Exclusion criteria: (1) Do not meet the inclusion criteria; (2) Scarred, allergic individuals; (3) Pregnant as well as lactating women; (4) Have received weight loss treatment within the last few months; (5) Serious life-threatening diseases such as cardiac, coagulation disorders, and psychiatric disorders.

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose;Fasting insulin;Glycosylated hemoglobin;C-peptide;Diet and exercise;Intestinal flora analysis;

Secondary

MeasureTime frame
Liver function;Renal function;Blood lipids;Leptin;Adiponectin;TCM symptoms;Body composition analysis ;

Countries

China

Contacts

Public ContactLi Li

Affiliated Hospital of Hangzhou Normal University

lislucy@163.com+86 135 2680 6000

Outcome results

None listed

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