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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04303481
Enrollment
88
Registered
2020-03-11
Start date
2019-08-10
Completion date
2019-12-31
Last updated
2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiota

Keywords

Anthropometric index, Biochemical items

Brief summary

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

Interventions

OTHERnormal diet

Control

OTHERweight loss program kit

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.

OTHERweight loss program kit with A. muciniphila prebiotics

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

Sponsors

TCI Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The change of visceral fatMonths 0, 1 and 2The visceral fat (10 cm\^2) was assessed by InBody770.
The change of TriglycerideMonths 0, 1 and 2Venous blood was sampled to measure concentrations of Triglyceride
The change of Total cholestrolMonths 0, 1 and 2Venous blood was sampled to measure concentrations of Total cholestrol
The change of HDL-cholestrolMonths 0, 1 and 2Venous blood was sampled to measure concentrations of HDL-cholestrol
The change of LDL-cholestrolMonths 0, 1 and 2Venous blood was sampled to measure concentrations of LDL-cholestrol
Fecal microbiome analysisMonths 0, 1 and 2Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR.
The change of body mass index (BMI)Months 0, 1 and 2BMI 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.
The change of body fat percentageMonths 0, 1 and 2The body fat percentage (%) was assessed by InBody770.
The change of body fat massMonths 0, 1 and 2The body fat mass (kg) was assessed by InBody770.

Secondary

MeasureTime frameDescription
The change of aspartate aminotransferaseMonths 0, 1 and 2Venous blood was sampled to measure concentrations of aspartate aminotransferase
The change of alanine aminotransferaseMonths 0, 1 and 2Venous blood was sampled to measure concentrations of alanine aminotransferase
The change of albuminMonths 0, 1 and 2Venous blood was sampled to measure concentrations of albumin
The change of creatineMonths 0, 1 and 2Venous blood was sampled to measure concentrations of creatine
The change of uric acidMonths 0, 1 and 2Venous blood was sampled to measure concentrations of uric acid
The change of white blood cellMonths 0, 1 and 2Venous blood was sampled to measure concentrations of white blood cell
The change of fasting glycemiaMonths 0, 1 and 2Venous blood was sampled to measure concentrations of fasting glycemia

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026