NCT04692792

Brief Summary

To assess the Dai Dai flower extract on body weight control

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 Jan 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

August 4, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

December 29, 2020

Last Update Submit

August 3, 2021

Conditions

Gastroenterology

Keywords

ObesityWeight controlDai Dai flower

Outcome Measures

Primary Outcomes (2)

  • The change of body weight

    The body weight (kg) was assessed by InBody.

    Change from Baseline body weight at 8 weeks

  • The change of BMI

    The BMI was assessed by InBody.

    Change from Baseline BMI at 8 weeks

Secondary Outcomes (19)

  • The change of body fat mass

    Change from Baseline body fat mass at 8 weeks

  • The change of visceral fat mass

    Change from Baseline visceral fat mass at 8 weeks

  • The change of waist-hip ratio

    Change from Baseline waist-hip ratio at 8 weeks

  • The change of basal metabolic rate

    Change from Baseline basal metabolic rate at 8 weeks

  • The change of AST

    Change from Baseline AST at 8 weeks

  • +14 more secondary outcomes

Study Arms (2)

Placebo drink

PLACEBO COMPARATOR
Dietary Supplement: Placebo drink

Dai Dai flower drink

EXPERIMENTAL
Dietary Supplement: Dai Dai flower drink

Interventions

Placebo drinkDIETARY_SUPPLEMENT

consume 1 bottle (50 mL) per day for 8 weeks

Placebo drink
Dai Dai flower drinkDIETARY_SUPPLEMENT

consume 1 bottle (50 mL) per day for 8 weeks

Dai Dai flower drink

Eligibility Criteria

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

You may qualify if:

  • Healthy male or female aged between 20 and 60 years old
  • Body mass index (BMI) ≥ 24 (kg/m\^2) or body fat mass ≥ 25%

You may not qualify if:

  • Pregnant or breastfeeding woman
  • Implementation in weight loss programs, consumption drugs or supplements for weight control before 3 months of this study
  • Participate weight control or fat loss human studies before 3 months of this study
  • History of cardiovascular disease, liver disease, kidney disease, endocrine disease, or other major organic diseases (according to subjects reporting).
  • Person who has received major surgery or bariatric surgery (according to medical history).
  • Person who has received constant drug use.
  • People with mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hsiu-Mei Chiang, Prof.

    China Medical University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2020

First Posted

January 5, 2021

Study Start

January 4, 2021

Primary Completion

March 6, 2021

Study Completion

June 15, 2021

Last Updated

August 4, 2021

Record last verified: 2021-08

Locations

TW(1)