NCT03594799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

4.3 years

First QC Date

November 24, 2017

Last Update Submit

January 25, 2021

Conditions

WeightlessnessWeightlessness; Adverse Effect

Keywords

Simulated MicrogravityWeightlessnessCountermeasureBedrest

Outcome Measures

Primary Outcomes (1)

  • Change in fasting plasma triglycerides concentration

    Plasma triglycerides concentration will be analyzed by enzymatic colorimetric method (reagent kit) after ultracentrifugation to isolate chylomicrons and Very Low Density Lipoproteins

    60 days

Secondary Outcomes (19)

  • Change in vertebral bone marrow fat fraction.

    60 days

  • Change in B lymphopoiesis

    60 days

  • Changes in myokines.

    60 days

  • Change in cardio-postural stability

    60 days

  • Change in insulin sensitivity

    60 days

  • +14 more secondary outcomes

Study Arms (2)

Bed Rest Control Group

EXPERIMENTAL

60 days of strict head-down tilt bed rest

Other: Bed Rest Control Group

Cocktail intervention

EXPERIMENTAL

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

Dietary Supplement: Cocktail intervention

Interventions

Bed Rest Control GroupOTHER

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

Bed Rest Control Group
Cocktail interventionDIETARY_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.

Cocktail intervention

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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,
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medes-Imps

Toulouse, 31400, France

Location

Related Publications (5)

  • 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.

    PMID: 36857962DERIVED

  • 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.

    PMID: 36251376DERIVED

  • 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.

    PMID: 34480570DERIVED

  • 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.

    PMID: 33831949DERIVED

  • 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.

    PMID: 33038096DERIVED

Study Officials

  • Arnaud BECK, MD

    MEDES - IMPS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2017

First Posted

July 20, 2018

Study Start

September 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)