NCT06203834

Brief Summary

The aim of this study is to investigate the effects of I-Fiber Pearl on Body Weight and Body Fat in Obese Adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2024

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

January 3, 2024

Last Update Submit

December 25, 2024

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

  • Change from baseline body weight at week 12

    Compared the difference of body weight between the week 12 and 0.

    Week 0, Week 12

  • Change from baseline body fat at week 12

    Compared the difference of body fat between the week 12 and 0.

    Week 0, Week 12

Study Arms (2)

placebo

PLACEBO COMPARATOR

Placebo 200g, without any ingredients of inulin fiber. Eat 200g for once, and once a day.

Dietary Supplement: placebo

I-Fiber Pearl

EXPERIMENTAL

I-Fiber Pearl 200g, with inulin fiber. Eat 200g for once, and once a day.

Dietary Supplement: I-Fiber Pearl

Interventions

I-Fiber PearlDIETARY_SUPPLEMENT

Eat 200g for once, and once a day.

I-Fiber Pearl
placeboDIETARY_SUPPLEMENT

Eat 200g for once, and once a day.

placebo

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female
  • aged 20-50 years old
  • body mass index is greater than or equal to 27 kg/m2
  • waist greater than or equal to 80 cm

You may not qualify if:

  • Subjects diagnosed with cancer and on curative care.
  • Subjects diagnosed with heart disease and on curative care.
  • Subjects who use other drugs whose pharmacological effects may affect the experiment or may aggravate the effects of the drug.
  • Subjects with systemic infection requiring antibiotics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, South, 402, Taiwan

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Chin-Lin Hsu, Ph.D.

    Chung Shan Medical University

    STUDY CHAIR

  • Chin-Lin Hsu, Ph.D.

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

  • Shiuan-Chih Chen, Dr.

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

  • Hung-Hsuan Kuo, Master

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

  • Chun-Tse Tsai, Master

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 12, 2024

Study Start

November 1, 2023

Primary Completion

September 18, 2024

Study Completion

September 30, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations

TW(1)