A New Nutritional Countermeasure to Prevent the Deconditioning Induced by 60 Days of Antiorthostatic Bed Rest

NCT ID: NCT03594799

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2020-12-31

Brief Summary

The objective of this study is to investigate whether the cocktail of natural antioxidants XXS-2A-BR2 comprising vitamin E and coupled with omega-3 helps to prevent and / or reduce the deleterious effects induced by long term physical inactivity through antiorthostatic bedrest. During a randomized 60 day bed rest study in 20 healthy male adults the two following aims will be undertaken:

• Sixteen scientific protocols will assess the changes in the cardiovascular, metabolism, muscle, bone, neuro sensorial, hematological and immunology systems.
• In the above mentioned systems, the potential beneficial effects of the countermeasure protocol will also be investigated.

Detailed Description

Space flights have shown the possibilities and limitations of human adaptation to space. For the last 50 years, results showed that the space environment and microgravity in particular, cause changes that may affect the performance of astronauts. These physiological changes particularly challenge the cardiovascular, metabolic, muscle and bone functions. Space agencies regularly conduct simulations on the ground on healthy volunteers to mimic the effects of weightlessness (head down bed rest model) to better understand the mechanisms of adaptations of the organism to space, and develop ways to prevent and / or reduce the negative biological effects of microgravity on astronauts. These protocols are called countermeasures. Since the beginning of space missions, various countermeasures have been tested on the ground and in-flight, including different exercise protocols. To date, however, none has been entirely satisfactory and space agencies continue to conduct simulation studies to evaluate new countermeasures. Nowadays, the human spaceflight program has entered the next phase of space exploration towards the Moon and Mars and there are clearly inherent medical challenges with such a goal, among which, countermeasure developments are a clear priority.

Based on recent evidences, the next countermeasure to be tested during a 60-day bed rest includes a nutritional countermeasure composed of an anti-oxidant and anti-inflammatory dietary mix.

Conditions

Weightlessness; Weightlessness; Adverse Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Bed Rest Control Group

60 days of strict head-down tilt bed rest

Group Type: EXPERIMENTAL

Bed Rest Control Group

Intervention Type: OTHER

Subjects are in strict head down tilt bed rest at all time (including for taking showers etc.) for 60 days.

Cocktail intervention

60 days of strict head-down tilt bed rest along with a Cocktail supplementation composed of natural antioxidants XXS-2A-BR2 comprising vitamin E, Selenium and coupled with omega-3

Group Type: EXPERIMENTAL

Cocktail intervention

Intervention Type: DIETARY_SUPPLEMENT

Subjects are in strict head down tilt bed rest at all time (including for taking showers etc.) for 60 days. In addition subjects are receiving a daily supplementation of a Cocktail. The daily dose of Cocktail consists of 6 pills per day: 2 at breakfast, 2 at lunch and 2 at diner. This will be equivalent to a daily dose of around 741 mg of bioactive polyphenols associated with Omega-3, Selenium and Vitamine E.

Interventions

Bed Rest Control Group

Subjects are in strict head down tilt bed rest at all time (including for taking showers etc.) for 60 days.

Intervention Type: OTHER

Cocktail intervention

Subjects are in strict head down tilt bed rest at all time (including for taking showers etc.) for 60 days. In addition subjects are receiving a daily supplementation of a Cocktail. The daily dose of Cocktail consists of 6 pills per day: 2 at breakfast, 2 at lunch and 2 at diner. This will be equivalent to a daily dose of around 741 mg of bioactive polyphenols associated with Omega-3, Selenium and Vitamine E.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Healthy male volunteer (see below the description of medical tests and laboratory analysis performed at the selection visit),
• Age 20 to 45,
• No overweight nor excessive thinness with BMI (weight Kg/ height m2) between 22 and 27,
• Height between 158 and 190 cm,
• No personal nor family past record of chronic or acute disease or psychological disturbances which could affect the physiological data and/or create a risk for the subject during the experiment,
• Fitness level assessment:

• if age < 35 years: 35 ml/min./kg < VO2max < 60ml/min./kg,
• if age > 35 years: 30 ml/min./kg < VO2max < 60ml/min./kg
• Active and free from any orthopedic, musculoskeletal and cardiovascular disorders,
• Non smokers,
• No alcohol, no drug dependence and no medical treatment,
• No shift work or travel across more than one time zone in previous 2 months,
• Covered by a Social Security system,
• Have signed the information consent,
• Free of any engagement during the three hospitalization planned periods.

Exclusion Criteria

• - Past record of orthostatic intolerance,
• Cardiac rhythm disorders,
• Chronic back pains,
• History of hiatus hernia or gastro-esophageal reflux,
• History of thyroid dysfunction, renal stones, diabetes, migraines,
• Past records of thrombophlebitis, family history of thrombosis or positive response in thrombosis screening procedure,
• Allergy including xylocaine allergy
• Abnormal result for lower limbs echo-doppler,
• History or active claustrophobia,
• History of genetic muscle and bone diseases of any kind,
• History of sleep disorders, no shift work or travel across more than one time zone in previous two months
• Vestibular disorders,
• Audition problem,
• Vision corrected no more than 20/30, color-blindness
• Bone mineral density: T-score ≤ -1.5,
• Osteosynthesis material, presence of metallic implants,
• History of knee problems or joint surgery/broken leg
• 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,
• Special food diet, vegetarian or vegan, food allergy especially allergic to peanut or soya.
• 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,
• Subject already participating or in the exclusion period of a clinical research,
• Refusal to give permission to contact his general practitioner,
• Incarcerated persons,
• 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 who has received more than 4500 Euros within 12 months for being a research subject.
• Subject under guardianship or trusteeship.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

European Space Agency

OTHER

Sponsor Role: collaborator

Centre National d'Etudes Spatiales

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnaud BECK, MD

Role: PRINCIPAL_INVESTIGATOR

MEDES - IMPS

Locations

Medes-Imps

Toulouse, , France

Countries

France

References

Trim WV, Walhin JP, Koumanov F, Turner JE, Shur NF, Simpson EJ, Macdonald IA, Greenhaff PL, Thompson D. The impact of physical inactivity on glucose homeostasis when diet is adjusted to maintain energy balance in healthy, young males. Clin Nutr. 2023 Apr;42(4):532-540. doi: 10.1016/j.clnu.2023.02.006. Epub 2023 Feb 16.

Reference Type: DERIVED

PMID: 36857962 (View on PubMed)

Stratis D, Trudel G, Rocheleau L, Pelchat M, Laneuville O. The Characteristic Response of the Human Leukocyte Transcriptome to 60 Days of Bed Rest and to Reambulation. Med Sci Sports Exerc. 2023 Mar 1;55(3):365-375. doi: 10.1249/MSS.0000000000003071. Epub 2022 Oct 15.

Reference Type: DERIVED

PMID: 36251376 (View on PubMed)

Trim WV, Walhin JP, Koumanov F, Bouloumie A, Lindsay MA, Travers RL, Turner JE, Thompson D. The Impact of Long-term Physical Inactivity on Adipose Tissue Immunometabolism. J Clin Endocrinol Metab. 2022 Jan 1;107(1):177-191. doi: 10.1210/clinem/dgab647.

Reference Type: DERIVED

PMID: 34480570 (View on PubMed)

Austermann K, Baecker N, Zwart SR, Fimmers R, Frippiat JP, Stehle P, Smith SM, Heer M. Antioxidant Supplementation Does Not Affect Bone Turnover Markers During 60 Days of 6 degrees Head-Down Tilt Bed Rest: Results from an Exploratory Randomized Controlled Trial. J Nutr. 2021 Jun 1;151(6):1527-1538. doi: 10.1093/jn/nxab036.

Reference Type: DERIVED

PMID: 33831949 (View on PubMed)

Liu T, Melkus G, Ramsay T, Sheikh A, Laneuville O, Trudel G. Bone Marrow Reconversion With Reambulation: A Prospective Clinical Trial. Invest Radiol. 2021 Apr 1;56(4):215-223. doi: 10.1097/RLI.0000000000000730.

Reference Type: DERIVED

PMID: 33038096 (View on PubMed)

Other Identifiers

14-981

Identifier Type: -

Identifier Source: org_study_id