Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    12055349 [PUBMED-IDS]
Previous Study | Return to List | Next Study

A Nutrient Cocktail to Protect Against Physical Inactivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03313869
Recruitment Status : Completed
First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Centre National d'Etudes Spatiales

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 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.


Condition or disease Intervention/treatment Phase
Metabolic Disturbance Glucose Intolerance Physical Inactivity Glucose Metabolism Disorders Lipid Metabolism Disorders Oxidative Stress Dietary Supplement: XXS-2A + Omega-3 + Vitamin E + Selenium Dietary Supplement: control diet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : June 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control

Intervention: Reduction in daily steps up to 2000-3000 steps per day and no structured physical activity + High dose ingestion of fructose (3g/kg/day) glucose (0,5g/kg/day)in the last 10 days of the protocol No cocktail during the protocol

Healthy male volunteers in the active range of population (10000 to 15000 steps per day) aged 20-45 years, 22 BMI 27 158 cm height 190 cm, Certified as healthy by a comprehensive clinical assessment.

Dietary Supplement: control diet
habitual diet to be followed

Experimental: Cocktail intervention

Intervention: Reduction in daily steps up to 2000-3000 steps per day and no structured physical activity + High dose ingestion of fructose (3g/kg/day) glucose (0,5g/kg/day)in the last 10 days of the protocol + 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)

Healthy male volunteers in the active range of population (10000 to 15000 steps per day) aged 20-45 years, 22 BMI 27 158 cm height 190 cm, Certified as healthy by a comprehensive clinical assessment.

Dietary Supplement: XXS-2A + Omega-3 + Vitamin E + Selenium
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)




Primary Outcome Measures :
  1. Change in Lipid oxidation [ Time Frame: 20 days ]
    change in lipid oxidation as measured by indirect calorimetry during a 4h-OGTT


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313869


Locations
Layout table for location information
France
Medes-Imps
Toulouse, France, 31405
Sponsors and Collaborators
Centre National d'Etudes Spatiales

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Centre National d'Etudes Spatiales
ClinicalTrials.gov Identifier: NCT03313869     History of Changes
Other Study ID Numbers: CNES
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre National d'Etudes Spatiales:
Metabolism
Lipid oxidation
micronutrient cocktail supplementation
physical inactivity
glucose intolerance
oxidative stress
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Diseases
Glucose Metabolism Disorders
Glucose Intolerance
Lipid Metabolism Disorders
Disease
Pathologic Processes
Hyperglycemia
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Selenium
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents