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Completed

NCT Number: NCT03313869

A Nutrient Cocktail to Protect Against Physical Inactivity

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 to test as a new countermeasure in 2016 during the 60-d bed rest planed by ESA/CNES.

The objective of this study is to investigate whether the cocktail of natural antioxidants XXS-2A comprising vitamin E and coupled with omega-3 helps to prevent and / or reduce the glucose intolerance and improve oxidative defenses induced by 20 days of physical inactivity through daily step reduction

Although physical inactivity is reported to affect glucose tolerance within days of inactivity, we selected a period of 20 days for the effect of the cocktail to take place and assess secondary molecular mechanisms. The effect of this short period of inactivity on metabolism will moreover be boosted during the last 10 days by taking fructose, a sugar found in abundance in fruits, honey and juices, which is known to quickly trigger metabolic deregulation.

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Key information

Conditions

Metabolic Disturbance Behavior Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Oxidative Stress Physical Inactivity Sedentary Behavior

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medes-Imps

Toulouse, 31405, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

XXS-2A + Omega-3 + Vitamin E + Selenium

Dietary Supplement

Micronutrient cocktail supplementation with 560,7 mg/ day of polyphenols (3 pills/day), 2,1 g/day of omega-3 fatty-acids (3 pills/day), 168 mg/day of vitamin E and 80µg/day of selenium (1 pill/day)

control diet

Dietary Supplement

habitual diet to be followed

Primary outcomes

  1. Change in Lipid oxidation

    Time frame: 20 days

    change in lipid oxidation as measured by indirect calorimetry during a 4h-OGTT

Secondary outcomes

  1. Change in glucose concentration

    Time frame: 20 days

    Change in plasma glucose concentration during a 4h-OGTT

  2. Change in insulin concentration

    Time frame: 20 days

    Change in plasma insulin concentration during a 4h-OGTT

  3. Change in NEFA

    Time frame: 20 days

    Change in fasting plasma NEFA

  4. Change in triglycerides

    Time frame: 20 days

    Change in fasting plasma triglycerides

  5. de novo lipogenesis

    Time frame: 20 days

    incorporation of labelled fructose in VLDL-TG

  6. Change in fructose oxidation

    Time frame: 20 days

    Change in 13C recovery in breath samples from ingested 1-13C fructose

  7. Change in oxidative stress

    Time frame: 20 days

    Change in fasting reduced and oxidized glutathione

  8. Change in fat-free mass

    Time frame: 20 days

    Change in fat-free mass as measured by DXA

  9. muscle pathways involved in intertwined protein synthesis / insulin sensitivity

    Time frame: 4h for each day of test. 12h for all the protocol

    western blots with Vastes lateralis samples obtained from muscle biopsy

Sponsors and collaborators

Lead sponsor

Centre National d'Etudes Spatiales

Other Gov

Registry information

Official study title

Effects of a Cocktail XXS-2A/Omega-3 on Insulin Sensitivity and Oxidative Stress During a 20-day Period of Physical Inactivity: a Controlled, Randomized Pilot Study on 20 Healthy Men

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 18, 2017
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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