NCT00880646

Brief Summary

This study aims to investigate the effect of supplement containing L-arabinose and indigestible dextrin on body mass index, body fat mass, abdominal circumference, visceral fat mass, and serum biochemical parameters in overweight subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable obesity

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

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 29, 2009

Status Verified

October 1, 2009

First QC Date

April 13, 2009

Last Update Submit

October 28, 2009

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Body mass index

    20 weeks

Secondary Outcomes (7)

  • Body fat mass

    Every 4 weeks (Overall 20 weeks)

  • Abdominal circumference

    Every 4 weeks (Overall 20 weeks)

  • Visceral fat area by CT scan

    Week 0, Week 12

  • Serum lipid profile

    Every 4 weeks (Overall 20 weeks)

  • Serum adiponectin and leptin levels

    Week 0, Week 12

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: Oolong tea containing L-arabinose and indigestible dextrin

2

PLACEBO COMPARATOR
Dietary Supplement: Oolong tea (Placebo)

Interventions

Oolong tea containing L-arabinose and indigestible dextrinDIETARY_SUPPLEMENT
1
Oolong tea (Placebo)DIETARY_SUPPLEMENT
2

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy as based on medical history and physical examination
  • BMI between 25 and 30 kg/m2
  • Willing not to serve as blood donor during the study
  • Informed consent signed

You may not qualify if:

  • Female subjects who are pregnant or nursing a child
  • Participation in any clinical trial up to 90 days before Day 01 of this study
  • Renal or hepatic dysfunction
  • Heart disease
  • Under medication
  • Subjects who are taking functional food designed for weight loss or serum lipid reduction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University

Hiroshima, Hiroshima, 734-8551, Japan

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 14, 2009

Study Start

March 1, 2009

Study Completion

October 1, 2009

Last Updated

October 29, 2009

Record last verified: 2009-10

Locations

JP(1)