A Nutrient Cocktail to Protect Against Physical Inactivity

Sponsor

Centre National d'Etudes Spatiales (Other)

Overall Status

Completed

CT.gov ID

NCT03313869

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Jun 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Change in Lipid oxidation [20 days]
change in lipid oxidation as measured by indirect calorimetry during a 4h-OGTT

Secondary Outcome Measures

Change in glucose concentration [20 days]
Change in plasma glucose concentration during a 4h-OGTT
Change in insulin concentration [20 days]
Change in plasma insulin concentration during a 4h-OGTT
Change in NEFA [20 days]
Change in fasting plasma NEFA
Change in triglycerides [20 days]
Change in fasting plasma triglycerides
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 oxidative stress [20 days]
Change in fasting reduced and oxidized glutathione
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.