The effect of oral capsinoids supplementation on exercise-induced fatigue and molecular biomarkers involved in skeletal muscle fuel recovery in humans

ISRCTN ISRCTN13356971
DOI https://doi.org/10.1186/ISRCTN13356971
Secondary identifying numbers CCH IRB No. : 131233
Submission date
31/07/2019
Registration date
07/08/2019
Last edited
16/08/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Capsinoids (CSN), the novel non-pungent capsaicin analogs reported to promote metabolic health and exercise tolerance. Previous literature revealed that capsinoids administration could enhance fat oxidation, as well as suppress the body fat accumulation in humans. However, the vital molecular mechanism remains under investigation, as CSN considering as an ergogenic aid to enhance fat oxidation and energy restore. This study investigated the effect of post-exercise CSN supplementation on energy reliance, muscle glycogen resynthesis and changes in GLUT4 and p-Akt/Akt protein expressions in the skeletal muscle of young adults, during recovery.

Who can participate?
Nine healthy adult male volunteers (aged 21.4±0.2 years, height 171.8±1.8 cm, weight 64.9±4.3 kg, BMI 21.9±1.3 kg / m2, VO2max 47.1±1.8 ml/kg/min) of the Department of Physical Education, National Taichung University of Education participated in this study.

What does the study involve?
All subjects performed a crossover study and randomized to capsinoids and placebo trials. Participants undergo a cycling exercise challenge, muscle biopsied, blood and gaseous samples collect for analysis of metabolism, with a maximum interval from the beginning to the end of tests of two days.

What are the possible benefits and risks of participating?
The benefits for participants are to understand their own data related exercise physiology measurements and improve individual currently existing knowledge in the field of sports physiology. However, there were no possible risks existing in this experimental process because previous results have been published in SCI Journals using similar study design and experimental process.

Where is the study run from?
National Taichung University of Education.

When is the study starting and how long is it expected to run for?
August 2016 to January 2017

Who is funding the study?
Ministry of Science and Technology in Taiwan.

Who is the main contact?
Professor I-Shiung Cheng
ischeng1965@mail.ntcu.edu.tw

Contact information

Prof I-Shiung Cheng
Scientific

Department of Physical Education
National Taichung University of Education
No 140 Minsheng Road
West Dist
Taichung
40306
Taiwan

ORCiD logoORCID ID 0000-0002-0532-0367
Phone +886422183413
Email ischeng1965@mail.ntcu.edu.tw

Study information

Study designRandomised cross-over trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)School
Study typeTreatment
Participant information sheet ISRCTN13356971_PIS_v1_5Aug19.pdf
Scientific titleFffect of acute post-exercise capsinoids supplementation on energy substrate utilization in young adults
Study acronymN/A
Study objectivesWe hypothesized that oral CSN supplementation immediately after exercise may increase the fat oxidation and whole-body insulin sensitivity resulting as to replenish the muscle glycogen levels during post-exercise recovery. Therefore, we measured the glycogen concentration, GLUT4 expression, glucose/insulin, and gaseous exchange data to explore the evidence that post-exercise CSN supplementation could alter energy reliance and enhance glycogen content in skeletal muscle of young men.
Ethics approval(s)Approved 04/03/2016, the Ethics Committee and Institutional Review Board (IRB) of Changhua Christian Hospital (50006 No. 20 Jianbao Street, Changhua City, Taiwan; d9065@cch.org.tw; +886-4-7238595), ref: CCH IRB No.131233.
Health condition(s) or problem(s) studiedAll participants in this study were non-alcoholics and non-smokers with a stable medical condition. To avoid the influence of other factors on results, participants were instructed to have a balanced diet and healthy lifestyle. In addition, the consumption of caffeine, tea, and tobacco was strictly prohibited during the experimental period.
InterventionParticipants in this crossover designed study were randomly assigned into two trials, including placebo and CSN (capsinoids).

All participants performed a 60-min cycling exercise on an ergometer at 70% VO2max. While performing the exercise and during recovery, participants had free access to drinking water. Then, immediately after a 60-min exercise, subjects ingested with CSN or placebo capsules (12 mg) and a high-carbohydrate meal within 10-min. Each meal consisted of 80% carbohydrate (2 g/kg body weight), 8% fat, 12% protein, and overall GI was 76·6 with an average weight of 184±7 g. The items in carbohydrate meal include corn flakes (Kellogg’s Ltd, Manchester, UK), skimmed milk, white bread, strawberry jam, glucose water, and water.

Muscle biopsies were performed immediately (0h) and 3h after exercise, and collected vastus lateralis muscle samples were stored at -80°C for further analyses. Simultaneously, blood and gaseous samples were collected before, immediately after exercise (0h) and during the 3h post-exercise recovery period.

We choose the dose of 12 mg of CSN as an oral supplement, which is also a similar dosage to the human study of Josse and colleagues. The CSN capsules were purchased from the Ajinomoto Co Inc (Ajinomoto, Tokyo, Japan).

The same trial was repeated following the 2-week washout interval with the same dose of CSN and placebo capsules.
Intervention typeSupplement
Primary outcome measure1. Glycogen levels in biopsied skeletal muscles are measured using an aseptic technique, an incision (10 mm length and depth) was made in the skin and muscle fascia at about 20 cm above the knee of the right leg at 0-h (immediately after exercise) and 3-h after exercise.
2. Fat oxidation rate in a gaseous sample is measured using MetaMax3B indirect calorimetry (Cortex Biophysik, Nonnenstrasse, Leipzing, Germany) to collect individual’s gaseous samples at every 60-min during 3h post-exercise recovery i.e., at 60, 120 and 180-min after exercise for both trials.
Secondary outcome measures1. p-Akt/Akt ratio is measured using Western blot in muscle biopsied samples at 0-h and 3-h after exercise.
2. GLUT4 expression using Western blot in muscle samples at 0-h and 3-h after exercise.
3. Blood glucose is measured using an automated glucose analyzer supplied by YSI Life Sciences (Yellow Springs, OH, USA) at every 30-min during 3h post-exercise recovery.
4. Insulin is measured using commercially available kits (Randox, Antrim, UK) on an automated analyzer (Hitachi 7020, Tokyo, Japan). at every 30-min during 3h post-exercise recovery.
5. NEFA is measured using commercially available kits (Randox, Antrim, UK) on an automated analyzer (Hitachi 7020, Tokyo, Japan). at every 30-min during 3h post-exercise recovery.
6. Glycerol concentrations are measured using commercially available kits (Randox, Antrim, UK) on an automated analyzer (Hitachi 7020, Tokyo, Japan). at every 30-min during 3h post-exercise recovery.
Overall study start date31/12/2015
Completion date16/04/2017

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexMale
Target number of participants9
Key inclusion criteria1. Healthy male college student.
2. Non-alcoholic.
3. Non-smoker.
4. Stable medical condition.
Key exclusion criteria1. Can’t follow the suggestions of a balanced diet 3 days before the experimental process.
2. Consume caffeine, tea, and tobacco and can’t be strictly prohibited during the experimental period.
3. Can’t tolerance the cycling exercise challenge including VO2max test and completed a 60-min cycling exercise at 70% VO2max.
Date of first enrolment15/04/2016
Date of final enrolment15/05/2016

Locations

Countries of recruitment

  • Taiwan

Study participating centre

National Taichung University of Education
No 140 Minsheng Road, West Dist, Taichung City, Taiwan
Taichung
40306
Taiwan

Sponsor information

Ministry of Science and Technology
Government

No. 106, Section 2
Heping East Road
Taipei
10622
Taiwan

Phone +886227737992
Email jenywu@most.gov.tw
Website http//www.most.gov.tw
ROR logo "ROR" https://ror.org/02kv4zf79

Funders

Funder type

Government

Ministry of Science and Technology, Taiwan
Government organisation / National government
Alternative name(s)
Ministry of Science and Technology, R.O.C. (Taiwan), Ministry of Science and Technology of Taiwan, MOST
Location
Taiwan

Results and Publications

Intention to publish date30/08/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in the PLOS ONE Journal.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version v1 05/08/2019 16/08/2019 No Yes

Additional files

ISRCTN13356971_PIS_v1_5Aug19.pdf
Uploaded 16/08/2019

Editorial Notes

16/08/2019: The participant information sheet was uploaded.
05/08/2019: Trial's existence confirmed by the Ethics Committee and Institutional Review Board of Changhua Christian Hospital.