Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/12/2010
Date assigned
21/01/2011
Last edited
21/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr I-Shiung Cheng

ORCID ID

Contact details

140
Ming Sheng Road
Taichung City
403
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRB951222

Study information

Scientific title

Oral hydroxycitric acid (HCA) supplementation enhances glycogen synthesis in exercised human skeletal 1 muscle: a randomised placebo-controlled cross-over trial

Acronym

HCA, GLUT4,FAT/CD36

Study hypothesis

In this study, we tested the hypothesis that oral hydroxycitric acid (HCA) supplementation might increase muscle glycogen stores and increase insulin sensitivity after exercise in humans, based on the evidence from mice studies.

Ethics approval

National Taiwan Sport University Ethics Committee approved on the 12th December 2006

Study design

Randomised placebo controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Glycogen synthesis in human skeletal muscle

Intervention

Since we aimed to determine the HCA effect on recovery, HCA and placebo meals were provided to the subjects immediately after exercise. HCA trial provided a meal containing 70% carbohydrate content with 500 mg HCA in half litre of drinking water for a 3-hour recovery, whereas the placebo trial (placebo, eight comparisons) provided a diet containing 70% carbohydrate content plus same volume of drinking water. In particular, carbohydrate meal contained 2 g carbohydrate per kilogram of body weight. The decision for HCA dosage was based on previous human report which demonstrated positive ergogenic effect on endurance performance.

Subjects performed a 60-mins cycling at 75% VO2max. Muscle biopsy samples, blood samples and gaseous samples were obtained immediately after exercise and during 3 hours after exercise.

Intervention type

Drug

Phase

Not Applicable

Drug names

Hydroxycitric acid

Primary outcome measures

Glycogen assay. Approximately 25 mg of skeletal muscle from the deep portion of the vastus lateralis was dissolved in 1 N KOH at 75°C for 30 minutes. Dissolved homogenate was neutralised by glacial acetic acid and incubated overnight in acetate buffer (0.3 M sodium acetate, pH to 4.8) containing amyloglucosidase (Boehringer Mannheim, Indianapolis, IN). The reaction mixture was neutralised with 1 N NaOH. Samples were then analysed by measuring glucosyl units by the Trinder reaction (Sigma, St. Louis, MO).

Secondary outcome measures

Molecular expressions of GLUT4, FAT/CD36, measured with reverse transcription-polymerase chain reaction (RT-PCR) and western blotting

Overall trial start date

01/08/2006

Overall trial end date

30/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy male volunteers
2. Aged 22.0 +/- 0.3 years
3. Height 171.3 +/- 0.7 cm
4. Weight 73.7 +/- 1.1 kg
5. Body mass index (BMI) 25.2 +/- 0.5 kg/m2
6. Ventilatory equivalent for oxygen (VEO2) 108
7. Peak 45.7 +/- 1.5 ml/kg/min

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

n = 8

Participant exclusion criteria

Male volunteer's VO2max less than 30 ml/kg/min

Recruitment start date

01/08/2006

Recruitment end date

30/04/2007

Locations

Countries of recruitment

Taiwan

Trial participating centre

140, Ming Sheng Road
Taichung City
403
Taiwan

Sponsor information

Organisation

National Science Council (Taiwan)

Sponsor details

106
Ho-Pei East Road
Taipei City
10622
Taiwan

Sponsor type

Government

Website

http://web1.nsc.gov.tw

Funders

Funder type

Government

Funder name

National Science Council (Taiwan) (ref: NSC 97-2140-H-166-007-MY2)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes