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Completed

NCT Number: NCT04501601

The Effect of Consuming on Body Composition and Blood Biochemistry Index

To assess the effect of consuming on body composition and blood biochemistry index

Completed

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Key information

Conditions

Gut Microbiota

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Pingtung University of Science and Technology

Pingtung City, Neipu Township, 91201, Taiwan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female aged between 20 and 60 years old
  • Body mass index (BMI) ≥ 24 (kg/m^2) or body fat mass: male > 25%, female > 30%
  • Prohibitions on other nutritional supplements (probiotics and prebiotics) before two weeks of the study
  • Abidance by the similar diet and exercise habits over the study.

Exclusion criteria

  • Pregnant or breastfeeding woman
  • Menopausal woman
  • Diabetes mellitus
  • Implementation in weight loss programs before a half year of this study
  • Metabolic disorders
  • Kidney diseases
  • Liver diseases
  • Cardiovascular diseases
  • Nervous system diseases
  • Gastrointestinal diseases
  • Heavy drinking or constant drug use.

Treatment and study plan

Fruit and vegetable solid drink

Dietary Supplement

weight loss program supplement

Primary outcomes

  1. The change of body fat mass

    Time frame: Change from Baseline body fat mass at 2 months

    The body fat mass (kg) was assessed by InBody770.

  2. The change of Triglyceride

    Time frame: Change from Baseline triglyceride at 2 months

    Venous blood was sampled to measure concentrations of Triglyceride

  3. The change of Total cholesterol

    Time frame: Change from Baseline total cholesterol at 2 months

    Venous blood was sampled to measure concentrations of Total cholestrol

  4. The change of HDL-cholesterol

    Time frame: Change from Baseline HDL-cholesterol at 2 months

    Venous blood was sampled to measure concentrations of HDL-cholestrol

  5. The change of LDL-cholesterol

    Time frame: Change from Baseline LDL-cholesterol at 2 months

    Venous blood was sampled to measure concentrations of LDL-cholestrol

  6. Fecal microbiome analysis

    Time frame: Change from Baseline Fecal microbiome at 2 months

    Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR.

  7. The change of body mass index (BMI)

    Time frame: Change from Baseline body mass index at 2 months

    BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m^2) and body mass (kg) were assessed by InBody770.

  8. The change of body fat percentage

    Time frame: Change from Baseline body fat percentage at 2 months

    The body fat percentage (%) was assessed by InBody770

  9. The change of visceral fat

    Time frame: Change from Baseline visceral fat at 2 months

    The visceral fat (10 cm^2) was assessed by InBody770.

Secondary outcomes

  1. The change of fasting glycemia

    Time frame: Change from Baseline fasting glycemia at 2 months

    Venous blood was sampled to measure concentrations of fasting glycemia

  2. The change of aspartate aminotransferase

    Time frame: Change from Baseline aspartate aminotransferase at 2 months

    Venous blood was sampled to measure concentrations of aspartate aminotransferase

  3. The change of alanine aminotransferase

    Time frame: Change from Baseline alanine aminotransferase at 2 months

    Venous blood was sampled to measure concentrations of alanine aminotransferase

  4. The change of albumin

    Time frame: Change from Baseline albumin at 2 months

    Venous blood was sampled to measure concentrations of albumin

  5. The change of creatinine

    Time frame: Change from Baseline creatinine at 2 months

    Venous blood was sampled to measure concentrations of creatine

  6. The change of uric acid

    Time frame: Change from Baseline uric acid at 2 months

    Venous blood was sampled to measure concentrations of uric acid

  7. The change of white blood cell

    Time frame: Change from Baseline white blood cell at 2 months

    Venous blood was sampled to measure concentrations of white blood cell

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2020
Registry last updated
Jan 15, 2021

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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