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A Nutrient Cocktail to Protect Against Physical Inactivity

Primary Purpose

Metabolic Disturbance, Glucose Intolerance, Physical Inactivity

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

XXS-2A + Omega-3 + Vitamin E + Selenium

control diet

About this trial

This is an interventional basic science trial for Metabolic Disturbance focused on measuring Metabolism, Lipid oxidation, micronutrient cocktail supplementation, physical inactivity, glucose intolerance, oxidative stress

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Medes-Imps

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Control

Cocktail intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Lipid oxidation

change in lipid oxidation as measured by indirect calorimetry during a 4h-OGTT

Secondary Outcome Measures

Change in glucose concentration

Change in plasma glucose concentration during a 4h-OGTT

Change in insulin concentration

Change in plasma insulin concentration during a 4h-OGTT

Change in NEFA

Change in fasting plasma NEFA

Change in triglycerides

Change in fasting plasma triglycerides

de novo lipogenesis

incorporation of labelled fructose in VLDL-TG

Change in fructose oxidation

Change in 13C recovery in breath samples from ingested 1-13C fructose

Change in oxidative stress

Change in fasting reduced and oxidized glutathione

Change in fat-free mass

Change in fat-free mass as measured by DXA

muscle pathways involved in intertwined protein synthesis / insulin sensitivity

western blots with Vastes lateralis samples obtained from muscle biopsy

Full Information

NCT ID

NCT03313869

First Posted

October 7, 2017

Last Updated

October 13, 2017

Sponsor

Centre National d'Etudes Spatiales

1. Study Identification

Unique Protocol Identification Number

NCT03313869

Brief Title

A Nutrient Cocktail to Protect Against Physical Inactivity

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

June 2015 (Actual)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre National d'Etudes Spatiales

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Disturbance, Glucose Intolerance, Physical Inactivity, Glucose Metabolism Disorders, Lipid Metabolism Disorders, Oxidative Stress

Keywords

Metabolism, Lipid oxidation, micronutrient cocktail supplementation, physical inactivity, glucose intolerance, oxidative stress

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Experimental

Arm Description

Arm Title

Cocktail intervention

Arm Type

Experimental

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

XXS-2A + Omega-3 + Vitamin E + Selenium

Intervention Description

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)

Intervention Type

Dietary Supplement

Intervention Name(s)

control diet

Intervention Description

habitual diet to be followed

Primary Outcome Measure Information:

Title

Change in Lipid oxidation

Description

change in lipid oxidation as measured by indirect calorimetry during a 4h-OGTT

Time Frame

20 days

Secondary Outcome Measure Information:

Title

Change in glucose concentration

Description

Change in plasma glucose concentration during a 4h-OGTT

Time Frame

20 days

Title

Change in insulin concentration

Description

Change in plasma insulin concentration during a 4h-OGTT

Time Frame

20 days

Title

Change in NEFA

Description

Change in fasting plasma NEFA

Time Frame

20 days

Title

Change in triglycerides

Description

Change in fasting plasma triglycerides

Time Frame

20 days

Title

de novo lipogenesis

Description

incorporation of labelled fructose in VLDL-TG

Time Frame

20 days

Title

Change in fructose oxidation

Description

Change in 13C recovery in breath samples from ingested 1-13C fructose

Time Frame

20 days

Title

Change in oxidative stress

Description

Change in fasting reduced and oxidized glutathione

Time Frame

20 days

Title

Change in fat-free mass

Description

Change in fat-free mass as measured by DXA

Time Frame

20 days

Title

muscle pathways involved in intertwined protein synthesis / insulin sensitivity

Description

western blots with Vastes lateralis samples obtained from muscle biopsy

Time Frame

4h for each day of test. 12h for all the protocol

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Medes-Imps

City

Toulouse

ZIP/Postal Code

31405

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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A Nutrient Cocktail to Protect Against Physical Inactivity

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