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Completed

NCT Number: NCT04303481

The Effect of Consuming Enzymes and Prebiotics on Body Composition and Blood Biochemical Index

To assess the effects of consuming enzymes and prebiotics on improvement of weight loss and biochemical parameters

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Key information

Conditions

Gut Microbiota

Age range

20 year–50 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 50 years old
  • Body mass index (BMI) ≥ 22 (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

Normal Diet

Other

Control

weight loss program kit

Other

Subjects should adhere to the eating plan, which contained the following kit components : four flavors of collagen drinks [i.e., Caviar Collagen Enzyme Drink, Collagen Enzyme Drinks (Peach Taste), Collagen Enzyme Drinks (Grape Fruit Taste), Saussurea involucrata Enzyme Drink (Litchi Taste)], six flavors of mike shakes (i.e., Corn Soup Mike Shake, Strawberry Mike Shake, Chocolate Mike Shake, Vanilla Mike Shake, Banana Mike Shakes, Matcha Mike Shakes), Fruit and Vegitable Congee, and Botanical Liquid Sachet.

weight loss program kit with A. muciniphila prebiotics

Other

Subjects should adhere to the eating plan, which contained the following kit components : four flavors of collagen drinks [i.e., Caviar Collagen Enzyme Drink, Collagen Enzyme Drinks (Peach Taste), Collagen Enzyme Drinks (Grape Fruit Taste), Saussurea involucrata Enzyme Drink (Litchi Taste)], six flavors of mike shakes (i.e., Corn Soup Mike Shake, Strawberry Mike Shake, Chocolate Mike Shake, Vanilla Mike Shake, Banana Mike Shakes, Matcha Mike Shakes), Fruit and Vegitable Congee, Botanical Liquid Sachet, and Probiotics Liquid Sachet

Primary outcomes

  1. The change of body fat mass

    Time frame: Months 0, 1 and 2

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

  2. The change of Triglyceride

    Time frame: Months 0, 1 and 2

    Venous blood was sampled to measure concentrations of Triglyceride

  3. The change of Total cholestrol

    Time frame: Months 0, 1 and 2

    Venous blood was sampled to measure concentrations of Total cholestrol

  4. The change of HDL-cholestrol

    Time frame: Months 0, 1 and 2

    Venous blood was sampled to measure concentrations of HDL-cholestrol

  5. The change of LDL-cholestrol

    Time frame: Months 0, 1 and 2

    Venous blood was sampled to measure concentrations of LDL-cholestrol

  6. Fecal microbiome analysis

    Time frame: Months 0, 1 and 2

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

  7. The change of body mass index (BMI)

    Time frame: Months 0, 1 and 2

    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: Months 0, 1 and 2

    The body fat percentage (%) was assessed by InBody770.

  9. The change of visceral fat

    Time frame: Months 0, 1 and 2

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

Secondary outcomes

  1. The change of fasting glycemia

    Time frame: Months 0, 1 and 2

    Venous blood was sampled to measure concentrations of fasting glycemia

  2. The change of aspartate aminotransferase

    Time frame: Months 0, 1 and 2

    Venous blood was sampled to measure concentrations of aspartate aminotransferase

  3. The change of alanine aminotransferase

    Time frame: Months 0, 1 and 2

    Venous blood was sampled to measure concentrations of alanine aminotransferase

  4. The change of albumin

    Time frame: Months 0, 1 and 2

    Venous blood was sampled to measure concentrations of albumin

  5. The change of creatine

    Time frame: Months 0, 1 and 2

    Venous blood was sampled to measure concentrations of creatine

  6. The change of uric acid

    Time frame: Months 0, 1 and 2

    Venous blood was sampled to measure concentrations of uric acid

  7. The change of white blood cell

    Time frame: Months 0, 1 and 2

    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
2019
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2020
Registry last updated
Mar 11, 2020

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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