A Nutrient Cocktail to Protect Against Physical Inactivity

October 13, 2017 updated by: Centre National d'Etudes Spatiales

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31405
        • Medes-Imps

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lipid oxidation
Time Frame: 20 days
change in lipid oxidation as measured by indirect calorimetry during a 4h-OGTT
20 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glucose concentration
Time Frame: 20 days
Change in plasma glucose concentration during a 4h-OGTT
20 days
Change in insulin concentration
Time Frame: 20 days
Change in plasma insulin concentration during a 4h-OGTT
20 days
Change in NEFA
Time Frame: 20 days
Change in fasting plasma NEFA
20 days
Change in triglycerides
Time Frame: 20 days
Change in fasting plasma triglycerides
20 days
de novo lipogenesis
Time Frame: 20 days
incorporation of labelled fructose in VLDL-TG
20 days
Change in fructose oxidation
Time Frame: 20 days
Change in 13C recovery in breath samples from ingested 1-13C fructose
20 days
Change in oxidative stress
Time Frame: 20 days
Change in fasting reduced and oxidized glutathione
20 days
Change in fat-free mass
Time Frame: 20 days
Change in fat-free mass as measured by DXA
20 days
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
4h for each day of test. 12h for all the protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre National d'Etudes Spatiales

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 7, 2017

First Submitted That Met QC Criteria

October 13, 2017

First Posted (Actual)

October 18, 2017

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 13, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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