NCT04501601

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

August 2, 2020

Last Update Submit

January 13, 2021

Conditions

Gut Microbiota

Keywords

Anthropometric indexBiochemical items

Outcome Measures

Primary Outcomes (9)

  • The change of body fat mass

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

    Change from Baseline body fat mass at 2 months

  • The change of Triglyceride

    Venous blood was sampled to measure concentrations of Triglyceride

    Change from Baseline triglyceride at 2 months

  • The change of Total cholesterol

    Venous blood was sampled to measure concentrations of Total cholestrol

    Change from Baseline total cholesterol at 2 months

  • The change of HDL-cholesterol

    Venous blood was sampled to measure concentrations of HDL-cholestrol

    Change from Baseline HDL-cholesterol at 2 months

  • The change of LDL-cholesterol

    Venous blood was sampled to measure concentrations of LDL-cholestrol

    Change from Baseline LDL-cholesterol at 2 months

  • Fecal microbiome analysis

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

    Change from Baseline Fecal microbiome at 2 months

  • The change of body mass index (BMI)

    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.

    Change from Baseline body mass index at 2 months

  • The change of body fat percentage

    The body fat percentage (%) was assessed by InBody770

    Change from Baseline body fat percentage at 2 months

  • The change of visceral fat

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

    Change from Baseline visceral fat at 2 months

Secondary Outcomes (7)

  • The change of fasting glycemia

    Change from Baseline fasting glycemia at 2 months

  • The change of aspartate aminotransferase

    Change from Baseline aspartate aminotransferase at 2 months

  • The change of alanine aminotransferase

    Change from Baseline alanine aminotransferase at 2 months

  • The change of albumin

    Change from Baseline albumin at 2 months

  • The change of creatinine

    Change from Baseline creatinine at 2 months

  • +2 more secondary outcomes

Study Arms (1)

Experimental: weight loss program kit

EXPERIMENTAL

weight loss program kit

Dietary Supplement: Fruit and vegetable solid drink

Interventions

Fruit and vegetable solid drinkDIETARY_SUPPLEMENT

weight loss program supplement

Experimental: weight loss program kit

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Pingtung University of Science and Technology

Pingtung City, Neipu Township, 91201, Taiwan

Location

MeSH Terms

Interventions

Fruit

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Bo-Han Wu

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2020

First Posted

August 6, 2020

Study Start

August 1, 2020

Primary Completion

October 1, 2020

Study Completion

December 31, 2020

Last Updated

January 15, 2021

Record last verified: 2021-01

Locations

TW(1)