The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults

TCI

Status: Active, not recruiting

Conditions: Weight Loss

Treatments: Dietary Supplement: Placebo; Dietary Supplement: TCI507 Probiotics; Dietary Supplement: TCI378 Probiotics

Study type: Interventional

Funder types: Industry

Identifiers

NCT04492605

201912029RSA

Details and patient eligibility

About

To assess the evaluation of TCI378 and TCI507 probiotics on weight-lowering efficacy in adults

Full description

This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The person who is evaluated as overweight by the doctor will be invited to participate in this trial. The efficacy assessment items and questionnaires are collected at every visit of the trial.

Enrollment: 96 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject.
2. BMI ≥ 24 or male body fat ≥ 25%, female body fat ≥ 30%.
3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.
4. No history of cardiovascular disease, history of organ transplantation, history of epilepsy or convulsions, liver and kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history).

Exclusion criteria

1. Pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental diseases, alcohol or drug abuse, and other major organic diseases (according to medical history).
2. No person who has undergone major surgery or bariatric surgery (according to medical history).
3. Drugs that affect body fat, waist circumference, or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability, have been used at present or within 3 months before participating in the screening Drugs (according to medical history).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo

TCI378 Probiotics

Experimental group

Description:

TCI378 Probiotics

Treatment:

Dietary Supplement: TCI378 Probiotics

TCI507 Probiotics

Experimental group

Description:

TCI507 Probiotics

Treatment:

Dietary Supplement: TCI507 Probiotics