An interventional study of FLEXMEAL : post-prandial blood sampling in Frailty and Sarcopenia, sponsored by Hospices Civils de Lyon. Not yet recruiting at 1 site in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Screening
Fibroblast Growth Factor 19 (FGF-19) is an intestinal hormone secreted in the post-prandial state, whose primary role is to inhibit bile acid synthesis in the liver. It is expressed by the FXR (Farnesoid X receptor) nuclear receptor in the enterocytes of the ileum, which is activated by specific bile acids metabolized in the gut microbiota. It was demonstrated that treatment with FGF-19 induces myofiber hypertrophy in vitro and increases muscle strength and mass in mice model of sarcopenia. Sarcopenia and the commonly associated physical frailty, are age-related syndromes associated with adverse events (such as falls and fractures, mobility disability) and increased mortality. Currently, there is no drug treatment that has been proven effective to counteract those syndromes and standard care consists in non-pharmacological interventions (exercise and nutrition) whose implementation remains complex due to several barriers. Moreover, the anabolic resistance underlying sarcopenia hampers the exercise-induced response on muscle mass and the level of evidence for this outcome remains poor-to-moderate. Thus, FGF-19 could be considered as a new regulator of skeletal muscle in elderly living with sarcopenia/frailty but there are, to date, only few data available in the literature. First and foremost, it is crucial to understand the relationship between postprandial FGF-19 and muscle which has not been characterized yet. Preliminary data suggest an inverse relationship between FGF-19 and physical function (OR= 0.33 [0.15;0.7] for the highest tertile of FGF-19) that persisted only in the cluster of frail individuals (OR= 0.19 [0.05;0.65]. Mechanistically, this suggests a positive feedback loop of the bile acids-gut-microbiota-FGF-19 in the presence of frailty/sarcopenia hence indicating that FGF-19 may be a novel biomarker of this condition.
1,229 studies on the registry are indexed under Frailty; 433 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 704 interventional studies indexed under Frailty.
Browse Frailty studies →Hospices Civils de Lyon is the lead sponsor of 1,856 studies on the registry; 442 are open to participants now.
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Exclusion Criteria:
Older adult (\>70 years) with a Short Physical Performance Battery (SPPB) score ≤8, confirmed frailty (≥ 3 criteria in the Fried's appendix of frailty) and a sarcopenia at least probable (regarding the revised European Working Group of Sarcopenia in Older People cut-offs ie. Low muscle strength either in the handgrip \<27kg in men and \<16kg in women or in the 5-repetitions chair stand test \>15s)
Biological: FLEXMEAL : post-prandial blood sampling
Older adult (\>70 years) with a SPPB score \>8, no frailty (no criterion in the Fried's appendix of frailty) and no sarcopenia (normal muscle strength regarding the European Working Group of Sarcopenia in Older People cut-offs).
Biological: FLEXMEAL : post-prandial blood sampling
Following inclusion, participants will be summoned within 30 days maximum. They will be asked to fast from 8 pm the night before and will receive specific instructions for their last meal. Prior to blood sampling, they will be seen by a doctor who will rule-out any contraindications to the test. If conditions are met, a trained nurse will insert a venous catheter and the intravenous infusion required for blood sampling. An initial sample will be taken in the fasting state. Then, participants will have to eat a standardized meal consisting of a vegetable soup enriched with cream, palm and rapeseed oil, together with a vanilla cream enriched with glucose. The meal will provide a total of 921 kcal with 20.1g of protein, 59.6 of fat and 75g of carbohydrates in total. Following meal, blood will be collected each hour during 4 hours. Participant will remain under constant medical supervision. After sampling, doctor will ensure that participant does not show any negative clinical signs.
Area Under Curve (AUC) of plasmatic post-prandial FGF-19 level
Blood samples will be stocked at -80 degrees in the laboratory and will be analyzed by ELISA kits at the end of the inclusion period.
Time frame: 0 min, 60 min, 120min, 180min, 240min
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2028, 16 months later.
Of 477 non-industry interventional studies with no phase under Frailty, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's planned 16 months is below that.
Counting every sponsor, half of 484 studies reached it within 21 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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