Clinical trial NCT04492605: The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
Official title: The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Weight Loss
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 96
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: The change of body fat mass
timeFrame: Weeks 0, 4 and 8
measure: The change of Triglyceride
timeFrame: Weeks 0, 4 and 8
measure: The change of Total cholestrol
timeFrame: Weeks 0, 4 and 8
measure: The change of HDL-cholestrol
timeFrame: Weeks 0, 4 and 8
measure: The change of LDL-cholestrol
timeFrame: Weeks 0, 4 and 8
measure: The change of body mass index (BMI)
timeFrame: Weeks 0, 4 and 8
measure: The change of body fat percentage
timeFrame: Weeks 0, 4 and 8
measure: The change of visceral fat
timeFrame: Weeks 0, 4 and 8
Secondary outcomes:
measure: The change of fasting glycemia
timeFrame: Weeks 0, 4 and 8
measure: The change of aspartate aminotransferase
timeFrame: Weeks 0, 4 and 8
measure: The change of alanine aminotransferase
timeFrame: Weeks 0, 4 and 8
measure: The change of albumin
timeFrame: Weeks 0, 4 and 8
measure: The change of creatine
timeFrame: Weeks 0, 4 and 8
measure: The change of uric acid
timeFrame: Weeks 0, 4 and 8
measure: The change of white blood cell
timeFrame: Weeks 0, 4 and 8
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: LIOU JYH-MING
role: PRINCIPAL_INVESTIGATOR
References: