Evaluation of the Body Slimming Effect of TCI904

NCT05805488 | Completed

• 1 other identifier: CMUH110-REC2-070
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy of Lactobacillus delbrueckii ssp. bulgaricus TCI904 on body slimming

Conditions

Body Weight; Metabolic Syndrome

Outcome Measures

Primary Outcomes (3)

• The change of body weight (kg)

  The body weight was assessed by Body Composition Monitor

  Week 0, week 12

• The change of BMI (kg/m^2)

  The BMI was assessed by Body Composition Monitor

  Week 0, week 12

• The change of body fat rate (%)

  The body fat rate was assessed by Body Composition Monitor

  Week 0, week 12

Secondary Outcomes (17)

• The change of total cholesterol

  Week 0, week 12

• The change of triglyceride

  Week 0, week 12

• The change of HDL-C

  Week 0, week 12

• The change of LDL-C

  Week 0, week 12

• The change of blood glucose

  Week 0, week 12

Study Arms (2)

Placebo sachet

PLACEBO COMPARATOR

Dietary Supplement: Placebo sachet

TCI904 sachet

EXPERIMENTAL

Dietary Supplement: TCI904 sachet

Interventions

Placebo sachet DIETARY_SUPPLEMENT

consume 1 sachet per day

Placebo sachet

TCI904 sachet DIETARY_SUPPLEMENT

consume 1 sachet per day

Also known as: Lactobacillus delbrueckii ssp. bulgaricus TCI904

TCI904 sachet

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 20
• BMI ≥ 23 or male body fat ≥ 25%, female body fat ≥ 30%.
• History of Atherosclerotic cardiovascular disease (including cerebrovascular disease, coronary heart disease, peripheral vascular disease) or Type 2 diabetes or have any of the following factors: Age Men ≥ 45 years, Women ≥ 55 years or amenorrhea, hypertension, hyperlipidemia (total cholesterol \> 200 mg/dL or low-density lipoprotein cholesterol LDL-C \> 130 mg/dL or triglyceride TG \> 130 mg/dL), high-density lipoprotein cholesterol HDL-C \< 40 mg/dL.
• If people have routinely taken drugs for lowering blood sugar, blood pressure or blood lipids, there is no significant dose change within three months (variation ≤ 20%).
• Volunteers who are willing to participate in and complete the trial plan after explaining by the researchers, and sign the consent form.

You may not qualify if:

• History of diabetic ketoacidosis.
• Medical records documented cerebrovascular disease, acute myocardial infarction or coronary artery bypass surgery or placement of coronary artery stents or peripheral vascular disease within the last 6 months.
• Known acute infectious illness within the past month with \> 7 days of antibiotics.
• Known short-term use of steroids, NSAIDs, anti-rejection drugs, interferon, immunomodulators or changes in long-term doses due to any factors in the past month.
• Have used any weight loss drugs (including Orlistate, Lorcaserin, liraglutide) within the past three months.
• History of any cancer in the past 5 years or still receiving cancer treatment.
• Patients with abnormal liver function (GOT or GPT greater than 3 times the upper limit of normal) or known cirrhosis.
• Patients with abnormal kidney function (eGFR \< 30 mL/min/1.73 m\^2).
• Patients with a history of alcoholism.
• Have participated in any other interventional clinical research within the last month.
• Pregnant and lactating women.
• Known history of allergy to the test substance.
• Patients who are judged inappropriate by the trial host.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

China Medical University

Taichung, Taiwan

Location

MeSH Terms

Conditions

Body Weight; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Yang-Chang Wu

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 10, 2023
• Study Start: October 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 10, 2023

Record last verified: 2023-03

Locations

TW (1)