A Nutrient Cocktail to Protect Against Physical Inactivity

Not Applicable

Completed

• Conditions: Physical Inactivity; Glucose Intolerance; Lipid Metabolism Disorders; Metabolic Disturbance; Glucose Metabolism Disorders; Oxidative Stress
• Interventions: Dietary Supplement: control diet; Dietary Supplement: XXS-2A + Omega-3 + Vitamin E + Selenium

• Registration Number: NCT03313869
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-10
• Study First Submitted: 2017-10-07
• Study First Submitted QC: 2017-10-13
• Last Update Submitted: 2017-10-13
• Study First Posted: 2017-10-18
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	control diet	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.
Cocktail intervention	XXS-2A + Omega-3 + Vitamin E + Selenium	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.

Primary Outcome Measures

Name	Time	Method
Change in Lipid oxidation	20 days	change in lipid oxidation as measured by indirect calorimetry during a 4h-OGTT

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medes-Imps; 🇫🇷 Toulouse, France