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Completed

NCT Number: NCT05805488

Evaluation of the Body Slimming Effect of TCI904

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Placebo sachet

Dietary Supplement

consume 1 sachet per day

TCI904 sachet

Dietary Supplement

consume 1 sachet per day

Other names: Lactobacillus delbrueckii ssp. bulgaricus TCI904

Primary outcomes

  1. The change of body weight (kg)

    Time frame: Week 0, week 12

    The body weight was assessed by Body Composition Monitor

  2. The change of BMI (kg/m^2)

    Time frame: Week 0, week 12

    The BMI was assessed by Body Composition Monitor

  3. The change of body fat rate (%)

    Time frame: Week 0, week 12

    The body fat rate was assessed by Body Composition Monitor

Secondary outcomes

  1. The change of total cholesterol

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of total cholesterol

  2. The change of triglyceride

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of triglyceride

  3. The change of HDL-C

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of HDL-C

  4. The change of LDL-C

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of LDL-C

  5. The change of blood glucose

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of glucose

  6. The change of C-reactive protein

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of C-reactive protein

  7. The change of insulin

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of insulin

  8. The change of HbA1c

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of HbA1c

  9. The change of TNF-alpha

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of TNF-alpha

  10. The change of Hypoxia-inducible factor 1-alpha (HIF-1alpha)

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of HIF-1alpha

  11. The change of cyclooxygenase-2 (COX-2)

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of COX-2

  12. The change of Matrix metalloproteinase (MMP)

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of MMP

  13. The change of aspartate aminotransferase

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of aspartate aminotransferase

  14. The change of alanine aminotransferase

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of alanine aminotransferase

  15. The change of albumin

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of albumin

  16. The change of creatine

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of creatine

  17. The change of blood urea nitrogen (BUN)

    Time frame: Week 0, week 12

    Fasting venous blood was sampled to measure concentrations of BUN

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Official study title

Evaluation of the Body Slimming Effect of Lactobacillus Delbrueckii Ssp. Bulgaricus TCI904

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 10, 2023
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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