Physiological and Molecular Influences of Astaxanthin Supplementation on Heat Strain in Humans

Body Temperature Regulation Clinical Trial

— Astaxanthin  

Official title:

Physiological and Molecular Influences of Astaxanthin Supplementation on Heat Strain in Humans

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02088242
• Other study ID #: SHEBA-13-0471-BA-CTIL
• Secondary ID: IDF-1295-2013
• Status: Not yet recruiting
• Phase: N/A
• First received: March 3, 2014
• Last updated: March 12, 2014
• Start date: May 2014
• Est. completion date: August 2015

Study information

• Verified date: March 2014
• Source: Sheba Medical Center
• Contact: Ofir Frenkel, M.D
• Phone: +972529243399
• Email: Ofir.Frenkel[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

Exposure to heat stress can compromise the physiological and cognitive function and be life threatening, particularly in a military setting. Various strategies of precondition to heat stress that have been explored in the past proved to be inapplicable. We aim to examine the influences of Astaxanthin supplementation as a preconditioning strategy to heat stress in a human model using a heat tolerance test. This will be achieved by a double-blind, placebo controlled supplementation trial, exposing human subjects, before and after consuming Astaxanthin or a placebo, to a controlled heat strain environment, while performing moderate exercise in a heated chamber.

Description:

34 young, healthy civilian volunteers will participate in this study. After reading and signing an informed consent form, all subjects will undergo medical examination and an interview with a nutritionist to assess their dietary intake of Astaxanthin. They will then undergo 3 days of training on the cognitive testing software.

During the first stage, while consuming an Astaxanthin free diet, the subjects will participate in the physiological tests:heat tolerance test (HTT), thermo-neutral test (TTT) and maximal oxygen consumption test (VO2max) on 3 separate days.

During the second stage, the subjects will be randomly and blindly assigned to either the placebo or the Astaxanthin supplementation arms, and undergo 35-40 days of supplementation.

Physiological testing of the second stage will take place between the 31st and 35th (up to 40th - optional) days of supplementation and will include HTT, TTT and VO2max on 3 separate days.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• Healthy civilian volunteers.

• Aged 20-30 years.

• Without known medical illness or medication use.

Exclusion Criteria:

• The existence or suspicion of existing cardiac or respiratory disease.

• Hypertension.

• Diabetes.

• Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.

• Infectious disease 3 days prior to the experiment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Body Temperature Regulation

Intervention

Drug:
• Astaxanthin
Oral supplementation with the food supplement Astaxanthin. Subjects receiving Astaxanthin will be asked to ingest 3 capsules containing 4mg of Astaxanthin each (a daily dose of 12mg).
• Placebo
3 capsules identical in shape, colour and size to the Astaxanthin capsules, which contain only the inactive ingredients of the same formulation.

Locations

Country	Name	City	State
Israel	Sheba medical center	Tel-Hashomer, Ramat- Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological strain	The physiological strain will be determined by monitoring body core temperature and heart rate of the subjects during a heat tolerance test (HTT) and a thermo-neutral test (TTT).The test is performed in a climatic chamber. During the test, the subject walks on a treadmill at a speed of 5 km/hr at a 2% grade for 2h. Body core temperature and heart rate are continuously monitored, and sweat rate is computed from body weight prior to and after the test, corrected for fluid intake.	2 months for each participant	Yes
Primary	Aerobic capacity	The aerobic capacity of the subjects will be determined by performing a maximal oxygen consumption test (VO2max). Volunteer's oxygen consumption (VO2) will be monitored continuously with a metabolic chart (ZAN- the name of the metabolic system), while running for 10 min on a treadmill under comfortable environmental conditions.	2 months for each participant	Yes
Secondary	Rectal temperature	The rectal temperature will be monitored by a rectal thermistor during each heat tolerance test (HTT) and thermo-neutral test (TTT) and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system (Biopac is the company in which the monitoring system was made).	2 months for each participant	Yes
Secondary	Skin temperature	The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg) and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.	2 months for each participant	No
Secondary	Heart rate	The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).	2 months for each participant	Yes
Secondary	Sweat rate	Sweat rate will be calculated from the patients' body weight and fluid balance.	2 months for each participant	No
Secondary	Cognitive function	Cognitive function will be assessed using a cognitive testing software on laptop computers before and after performing the physiological tests.	2 months for each participant	No