Status:
COMPLETED
A Nutrient Cocktail to Protect Against Physical Inactivity
Lead Sponsor:
Centre National d'Etudes Spatiales
Conditions:
Metabolic Disturbance
Glucose Intolerance
Eligibility:
MALE
20-45 years
Phase:
NA
Brief Summary
This experiment consists on a 20-day reduction in daily step in free-living active individuals to induce physical inactivity. This will be used to test the efficacy of the anti-oxidant cocktail we aim...
Eligibility Criteria
Inclusion
- Healthy male subjects,
- Aged 20-45 years,
- No obesity or excessive thinness with BMI (weight Kg / height m2) between 22 and 27,
- Height (cm) between 158 and 190 cm,
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination): in particular, free from any chronic disease or any acute infectious disease or ENT, neurological, orthopaedic, musculoskeletal and cardiovascular disorders,
- In the active range of population (10000 to 15000 steps/day)
- No contraindication to lidocaïne,
- No allergy to peanuts or soya,
- Non smokers or smoking less than 5 cigarettes/day,
- No alcohol, no drug dependence and no medical treatment,
- Regulations
- Having given written informed consent prior to any procedure related to the study,
- Covered by Health Insurance System,
- Not under any administrative or legal supervision,
- Not under guardianship or trusteeship.
Exclusion
- Any history or presence of clinically relevant cardiovascular, neurological or ENT, any chronic disease; any acute infectious disease,
- Obesity or excessive thinness,
- Not in the active range of population (\<10000 steps/day),
- Ongoing medical treatment,
- Poor tolerance to blood sampling,
- Having given blood (more than 8ml/kg) in a period of 8 weeks or less before the start of the experiment,
- Subject with contraindication to lidocaïne,
- Special food diet, vegetarian or vegan or food supplementation,
- History of food allergy, especially allergy to peanuts or soya,
- A significant history of allergy,
- Positive reaction to any of the following tests: HVA IgM (hepatitis A), HBs antigen (hepatitis B), anti-HVC antibodies (hepatitis C), anti-HIV1+2 antibodies,
- History or presence of drug or alcohol abuse (alcohol consumption \> 40 grams/day).
- General conditions
- Subject who, in the judgment of the Investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development,
- Subject in the exclusion period of a previous study according to applicable regulations,
- Subject who has received more than 4500 Euros within 12 months for being a research subject,
- Subject who cannot be contacted in case of emergency,
- Incarcerated persons,
- Subject under guardianship or trusteeship.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03313869
Start Date
June 1 2015
End Date
December 1 2015
Last Update
October 18 2017
Active Locations (1)
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1
Medes-Imps
Toulouse, France, 31405