NCT05607524

Brief Summary

The purpose of this study was to evaluate the efficacy of 2 capsules (500 mg per capsule, 1000 mg per day) of Grape King Probiotic Capsules per day in promoting fat excretion in obese patients by clinical human food test.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

September 29, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2023

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

3 months

First QC Date

October 28, 2022

Last Update Submit

November 1, 2022

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline fecel lipid weight at week 4

    Compared the difference of fecel lipid weight level between the week 4 and 0

    Week0, Week4

Study Arms (2)

Probiotics

EXPERIMENTAL

Probiotic capsules, 500 mg each, two daily for a total of 1000 mg for 4 weeks

Dietary Supplement: probiotics

Placebo

PLACEBO COMPARATOR

The placebo capsules had the same composition as the experimental capsules, except that they did not contain probiotics, and should be used for 4 weeks.

Dietary Supplement: placebo

Interventions

probioticsDIETARY_SUPPLEMENT

Eat a capsule for once, and twice a day

Probiotics
placeboDIETARY_SUPPLEMENT

Eat a capsule for once, and twice a day

Placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male or female participants
  • aged 20-40 years old
  • body mass index in 25-27 kg/m2
  • body fat \> 25% for men and \> 30% for women

You may not qualify if:

  • cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity
  • having systemic infections
  • using probiotics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, South, 402, Taiwan

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Yu-Jou Chien, PhD student

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

  • Xin-Bei Lin, MS student

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin-Lin Hsu, Professor

CONTACT

04-24730022clhsu@csmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2022

First Posted

November 7, 2022

Study Start

September 29, 2022

Primary Completion

December 29, 2022

Study Completion

January 16, 2023

Last Updated

November 7, 2022

Record last verified: 2022-11

Locations

TW(1)