A Nutrient Cocktail to Protect Against Physical Inactivity

Oxidative Stress Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313869
• Other study ID #: CNES
• Status: Completed
• Phase: N/A
• First received: October 7, 2017
• Last updated: October 13, 2017
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: October 2017
• Source: Centre National d'Etudes Spatiales
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Glucose Intolerance
• Glucose Metabolism Disorders
• Lipid Metabolism Disorders
• Metabolic Diseases
• Metabolic Disturbance
• Oxidative Stress
• Physical Inactivity

Intervention

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)
• control diet
habitual diet to be followed

Locations

Country	Name	City	State
France	Medes-Imps	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre National d'Etudes Spatiales

Country where clinical trial is conducted

France, 

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* Note: There are 65 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Lipid oxidation	change in lipid oxidation as measured by indirect calorimetry during a 4h-OGTT	20 days
Secondary	Change in glucose concentration	Change in plasma glucose concentration during a 4h-OGTT	20 days
Secondary	Change in insulin concentration	Change in plasma insulin concentration during a 4h-OGTT	20 days
Secondary	Change in NEFA	Change in fasting plasma NEFA	20 days
Secondary	Change in triglycerides	Change in fasting plasma triglycerides	20 days
Secondary	de novo lipogenesis	incorporation of labelled fructose in VLDL-TG	20 days
Secondary	Change in fructose oxidation	Change in 13C recovery in breath samples from ingested 1-13C fructose	20 days
Secondary	Change in oxidative stress	Change in fasting reduced and oxidized glutathione	20 days
Secondary	Change in fat-free mass	Change in fat-free mass as measured by DXA	20 days
Secondary	muscle pathways involved in intertwined protein synthesis / insulin sensitivity	western blots with Vastes lateralis samples obtained from muscle biopsy	4h for each day of test. 12h for all the protocol