NCT06554314

Brief Summary

The purpose of this study was to evaluate the efficacy of 1 capsules (300 mg per capsule) of Nutrarex Probiotic Capsules per day in regulating gut health and blood lipid in adults by clinical trial.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

August 12, 2024

Last Update Submit

August 12, 2024

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline serum lipids at week 4

    Compared the difference of serum lipids level between the week 4 and 0

    Week0, Week4

Study Arms (2)

Probiotics

EXPERIMENTAL

Probiotic capsules, 300 mg each, one daily for a total of 300 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: probiotics

Interventions

probioticsDIETARY_SUPPLEMENT

Eat a capsule for once, and once a day

PlaceboProbiotics

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female participants
  • aged 20-65 years old
  • body mass index in 25-27 kg/m2 or 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

  • Yin-Chin Liu, 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
SPONSOR

Study Record Dates

First Submitted

August 12, 2024

First Posted

August 15, 2024

Study Start

May 17, 2024

Primary Completion

December 31, 2024

Study Completion

May 31, 2025

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations

TW(1)