Metabolic DisturbanceNCT03313869
A Nutrient Cocktail to Protect Against Physical Inactivity
A study testing XXS-2A + Omega-3 + Vitamin E + Selenium in people with Metabolic Disturbance and Glucose Intolerance, run by Centre National d'Etudes Spatiales at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disturbance, Glucose Intolerance, Physical Inactivity
- What is being tested?
- XXS-2A + Omega-3 + Vitamin E + Selenium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 15Show fewer
- 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.
Who cannot join
- 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,
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Metabolic Disturbance, Glucose Intolerance, Physical Inactivity, Glucose Metabolism Disorders, Lipid Metabolism Disorders, Oxidative Stress
- Being tested
- XXS-2A + Omega-3 + Vitamin E + Selenium, control diet
- Keywords
- Metabolism, Lipid oxidation, micronutrient cocktail supplementation, physical inactivity, glucose intolerance, oxidative stress
- Medical subject headings
- Glucose Intolerance, Sedentary Behavior, Glucose Metabolism Disorders, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XXS-2A + Omega-3 + Vitamin E + SeleniumDietary supplement
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)
control dietDietary supplement
habitual diet to be followed
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | 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. Receives: Dietary Supplement: control diet |
| Cocktail intervention | Experimental | 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. Receives: Dietary Supplement: XXS-2A + Omega-3 + Vitamin E + Selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lipid oxidation
change in lipid oxidation as measured by indirect calorimetry during a 4h-OGTT
Measured: 20 days
Secondary outcomes (9)
Change in glucose concentration
Change in plasma glucose concentration during a 4h-OGTT
Measured: 20 days
Change in insulin concentration
Change in plasma insulin concentration during a 4h-OGTT
Measured: 20 days
Change in NEFA
Change in fasting plasma NEFA
Measured: 20 days
Change in triglycerides
Change in fasting plasma triglycerides
Measured: 20 days
de novo lipogenesis
incorporation of labelled fructose in VLDL-TG
Measured: 20 days
Change in fructose oxidation
Change in 13C recovery in breath samples from ingested 1-13C fructose
Measured: 20 days
Change in oxidative stress
Change in fasting reduced and oxidized glutathione
Measured: 20 days
Change in fat-free mass
Change in fat-free mass as measured by DXA
Measured: 20 days
muscle pathways involved in intertwined protein synthesis / insulin sensitivity
western blots with Vastes lateralis samples obtained from muscle biopsy
Measured: 4h for each day of test. 12h for all the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (66)Papers the sponsor has linked to this study.
- Other trials for Metabolic DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre National d'Etudes Spatiales
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313869
- Sponsor's protocol ID
- CNES
- Status last verified
- Oct 2017
- First submitted
- 7 Oct 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Adams GR, Caiozzo VJ, Baldwin KM. Skeletal muscle unweighting: spaceflight and ground-based models. J Appl Physiol (1985). 2003 Dec;95(6):2185-201. doi: 10.1152/japplphysiol.00346.2003.
PubMed 14600160Alibegovic AC, Hojbjerre L, Sonne MP, van Hall G, Stallknecht B, Dela F, Vaag A. Impact of 9 days of bed rest on hepatic and peripheral insulin action, insulin secretion, and whole-body lipolysis in healthy young male offspring of patients with type 2 diabetes. Diabetes. 2009 Dec;58(12):2749-56. doi: 10.2337/db09-0369. Epub 2009 Aug 31.
PubMed 19720789Alibegovic AC, Sonne MP, Hojbjerre L, Bork-Jensen J, Jacobsen S, Nilsson E, Faerch K, Hiscock N, Mortensen B, Friedrichsen M, Stallknecht B, Dela F, Vaag A. Insulin resistance induced by physical inactivity is associated with multiple transcriptional changes in skeletal muscle in young men. Am J Physiol Endocrinol Metab. 2010 Nov;299(5):E752-63. doi: 10.1152/ajpendo.00590.2009. Epub 2010 Aug 24.
PubMed 20739510Bakker GC, van Erk MJ, Pellis L, Wopereis S, Rubingh CM, Cnubben NH, Kooistra T, van Ommen B, Hendriks HF. An antiinflammatory dietary mix modulates inflammation and oxidative and metabolic stress in overweight men: a nutrigenomics approach. Am J Clin Nutr. 2010 Apr;91(4):1044-59. doi: 10.3945/ajcn.2009.28822. Epub 2010 Feb 24.
PubMed 20181810Bergouignan A, Momken I, Lefai E, Antoun E, Schoeller DA, Platat C, Chery I, Zahariev A, Vidal H, Gabert L, Normand S, Freyssenet D, Laville M, Simon C, Blanc S. Activity energy expenditure is a major determinant of dietary fat oxidation and trafficking, but the deleterious effect of detraining is more marked than the beneficial effect of training at current recommendations. Am J Clin Nutr. 2013 Sep;98(3):648-58. doi: 10.3945/ajcn.112.057075. Epub 2013 Jul 31.
PubMed 23902784Bergouignan A, Momken I, Schoeller DA, Normand S, Zahariev A, Lescure B, Simon C, Blanc S. Regulation of energy balance during long-term physical inactivity induced by bed rest with and without exercise training. J Clin Endocrinol Metab. 2010 Mar;95(3):1045-53. doi: 10.1210/jc.2009-1005. Epub 2010 Jan 8.
PubMed 20061436Bergouignan A, Rudwill F, Simon C, Blanc S. Physical inactivity as the culprit of metabolic inflexibility: evidence from bed-rest studies. J Appl Physiol (1985). 2011 Oct;111(4):1201-10. doi: 10.1152/japplphysiol.00698.2011. Epub 2011 Aug 11.
PubMed 21836047Bergouignan A, Trudel G, Simon C, Chopard A, Schoeller DA, Momken I, Votruba SB, Desage M, Burdge GC, Gauquelin-Koch G, Normand S, Blanc S. Physical inactivity differentially alters dietary oleate and palmitate trafficking. Diabetes. 2009 Feb;58(2):367-76. doi: 10.2337/db08-0263. Epub 2008 Nov 18.
PubMed 19017764Bienso RS, Ringholm S, Kiilerich K, Aachmann-Andersen NJ, Krogh-Madsen R, Guerra B, Plomgaard P, van Hall G, Treebak JT, Saltin B, Lundby C, Calbet JA, Pilegaard H, Wojtaszewski JF. GLUT4 and glycogen synthase are key players in bed rest-induced insulin resistance. Diabetes. 2012 May;61(5):1090-9. doi: 10.2337/db11-0884. Epub 2012 Mar 8.
PubMed 22403297Biolo G, Agostini F, Simunic B, Sturma M, Torelli L, Preiser JC, Deby-Dupont G, Magni P, Strollo F, di Prampero P, Guarnieri G, Mekjavic IB, Pisot R, Narici MV. Positive energy balance is associated with accelerated muscle atrophy and increased erythrocyte glutathione turnover during 5 wk of bed rest. Am J Clin Nutr. 2008 Oct;88(4):950-8. doi: 10.1093/ajcn/88.4.950.
PubMed 18842781Blanc S, Normand S, Ritz P, Pachiaudi C, Vico L, Gharib C, Gauquelin-Koch G. Energy and water metabolism, body composition, and hormonal changes induced by 42 days of enforced inactivity and simulated weightlessness. J Clin Endocrinol Metab. 1998 Dec;83(12):4289-97. doi: 10.1210/jcem.83.12.5340.
PubMed 9851766Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, Atherton PJ, Phillips SM. Two weeks of reduced activity decreases leg lean mass and induces "anabolic resistance" of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013 Jun;98(6):2604-12. doi: 10.1210/jc.2013-1502. Epub 2013 Apr 15.
PubMed 23589526Buehlmeier J, Frings-Meuthen P, Remer T, Maser-Gluth C, Stehle P, Biolo G, Heer M. Alkaline salts to counteract bone resorption and protein wasting induced by high salt intake: results of a randomized controlled trial. J Clin Endocrinol Metab. 2012 Dec;97(12):4789-97. doi: 10.1210/jc.2012-2857. Epub 2012 Oct 1.
PubMed 23027921Cavanagh PR, Licata AA, Rice AJ; New Collective Author. Exercise and pharmacological countermeasures for bone loss during long-duration space flight. Gravit Space Biol Bull. 2005 Jun;18(2):39-58.
PubMed 16038092Chavez JA, Knotts TA, Wang LP, Li G, Dobrowsky RT, Florant GL, Summers SA. A role for ceramide, but not diacylglycerol, in the antagonism of insulin signal transduction by saturated fatty acids. J Biol Chem. 2003 Mar 21;278(12):10297-303. doi: 10.1074/jbc.M212307200. Epub 2003 Jan 13.
PubMed 12525490
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03313869
- Acronym / sponsor ID
- CNES
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre National d'Etudes SpatialesOther government
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Dietary Supplement: control dietIntervention: 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 | Experimental | Dietary Supplement: XXS-2A + Omega-3 + Vitamin E + SeleniumIntervention: 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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,
Key exclusion criteria (19 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XXS-2A + Omega-3 + Vitamin E + SeleniumMicronutrient 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) | Dietary supplement | Cocktail intervention |
| control diethabitual diet to be followed | Dietary supplement | Control |
Primary outcome
Change in Lipid oxidation
Time frame: 20 days
change in lipid oxidation as measured by indirect calorimetry during a 4h-OGTT
9 secondary outcomes
Change in glucose concentration
Time frame: 20 days
Change in insulin concentration
Time frame: 20 days
Change in NEFA
Time frame: 20 days
Change in triglycerides
Time frame: 20 days
de novo lipogenesis
Time frame: 20 days
Change in fructose oxidation
Time frame: 20 days
Change in oxidative stress
Time frame: 20 days
Change in fat-free mass
Time frame: 20 days
muscle pathways involved in intertwined protein synthesis / insulin sensitivity
Time frame: 4h for each day of test. 12h for all the protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Background: PubMed 14600160Adams GR, Caiozzo VJ, Baldwin KM. Skeletal muscle unweighting: spaceflight and ground-based models. J Appl Physiol (1985). 2003 Dec;95(6):2185-201. doi: 10.1152/japplphysiol.00346.2003.
- Background: PubMed 19720789Alibegovic AC, Hojbjerre L, Sonne MP, van Hall G, Stallknecht B, Dela F, Vaag A. Impact of 9 days of bed rest on hepatic and peripheral insulin action, insulin secretion, and whole-body lipolysis in healthy young male offspring of patients with type 2 diabetes. Diabetes. 2009 Dec;58(12):2749-56. doi: 10.2337/db09-0369. Epub 2009 Aug 31.
- Background: PubMed 20739510Alibegovic AC, Sonne MP, Hojbjerre L, Bork-Jensen J, Jacobsen S, Nilsson E, Faerch K, Hiscock N, Mortensen B, Friedrichsen M, Stallknecht B, Dela F, Vaag A. Insulin resistance induced by physical inactivity is associated with multiple transcriptional changes in skeletal muscle in young men. Am J Physiol Endocrinol Metab. 2010 Nov;299(5):E752-63. doi: 10.1152/ajpendo.00590.2009. Epub 2010 Aug 24.
- Background: PubMed 20181810Bakker GC, van Erk MJ, Pellis L, Wopereis S, Rubingh CM, Cnubben NH, Kooistra T, van Ommen B, Hendriks HF. An antiinflammatory dietary mix modulates inflammation and oxidative and metabolic stress in overweight men: a nutrigenomics approach. Am J Clin Nutr. 2010 Apr;91(4):1044-59. doi: 10.3945/ajcn.2009.28822. Epub 2010 Feb 24.
- Background: PubMed 23902784Bergouignan A, Momken I, Lefai E, Antoun E, Schoeller DA, Platat C, Chery I, Zahariev A, Vidal H, Gabert L, Normand S, Freyssenet D, Laville M, Simon C, Blanc S. Activity energy expenditure is a major determinant of dietary fat oxidation and trafficking, but the deleterious effect of detraining is more marked than the beneficial effect of training at current recommendations. Am J Clin Nutr. 2013 Sep;98(3):648-58. doi: 10.3945/ajcn.112.057075. Epub 2013 Jul 31.
- Background: PubMed 20061436Bergouignan A, Momken I, Schoeller DA, Normand S, Zahariev A, Lescure B, Simon C, Blanc S. Regulation of energy balance during long-term physical inactivity induced by bed rest with and without exercise training. J Clin Endocrinol Metab. 2010 Mar;95(3):1045-53. doi: 10.1210/jc.2009-1005. Epub 2010 Jan 8.
- Background: PubMed 21836047Bergouignan A, Rudwill F, Simon C, Blanc S. Physical inactivity as the culprit of metabolic inflexibility: evidence from bed-rest studies. J Appl Physiol (1985). 2011 Oct;111(4):1201-10. doi: 10.1152/japplphysiol.00698.2011. Epub 2011 Aug 11.
- Background: PubMed 19017764Bergouignan A, Trudel G, Simon C, Chopard A, Schoeller DA, Momken I, Votruba SB, Desage M, Burdge GC, Gauquelin-Koch G, Normand S, Blanc S. Physical inactivity differentially alters dietary oleate and palmitate trafficking. Diabetes. 2009 Feb;58(2):367-76. doi: 10.2337/db08-0263. Epub 2008 Nov 18.
- Background: PubMed 22403297Bienso RS, Ringholm S, Kiilerich K, Aachmann-Andersen NJ, Krogh-Madsen R, Guerra B, Plomgaard P, van Hall G, Treebak JT, Saltin B, Lundby C, Calbet JA, Pilegaard H, Wojtaszewski JF. GLUT4 and glycogen synthase are key players in bed rest-induced insulin resistance. Diabetes. 2012 May;61(5):1090-9. doi: 10.2337/db11-0884. Epub 2012 Mar 8.
- Background: PubMed 18842781Biolo G, Agostini F, Simunic B, Sturma M, Torelli L, Preiser JC, Deby-Dupont G, Magni P, Strollo F, di Prampero P, Guarnieri G, Mekjavic IB, Pisot R, Narici MV. Positive energy balance is associated with accelerated muscle atrophy and increased erythrocyte glutathione turnover during 5 wk of bed rest. Am J Clin Nutr. 2008 Oct;88(4):950-8. doi: 10.1093/ajcn/88.4.950.
- Background: PubMed 9851766Blanc S, Normand S, Ritz P, Pachiaudi C, Vico L, Gharib C, Gauquelin-Koch G. Energy and water metabolism, body composition, and hormonal changes induced by 42 days of enforced inactivity and simulated weightlessness. J Clin Endocrinol Metab. 1998 Dec;83(12):4289-97. doi: 10.1210/jcem.83.12.5340.
- Background: PubMed 23589526Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, Atherton PJ, Phillips SM. Two weeks of reduced activity decreases leg lean mass and induces "anabolic resistance" of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013 Jun;98(6):2604-12. doi: 10.1210/jc.2013-1502. Epub 2013 Apr 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XXS-2A + Omega-3 + Vitamin E + Selenium in people with Metabolic Disturbance and Glucose Intolerance, run by Centre National d'Etudes Spatiales at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lipid oxidation (time frame: 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03313869, which also lists 66 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2017.