PROfiles of FGF-19 Post-prandial Secretion in Older Adults With Frailty and Without Frailty

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

70 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

30 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Age ≥70 years
• Give his/her informed consent
• For the FRAIL group: SPPB ≤8, confirmed frailty (≥ 3 criteria in the Fried's appendix of frailty) and a at least a probable sarcopenia (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)
• For the ROBUST group: SPPB \>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).

Exclusion Criteria:

• Individuals who have undergone cholecystectomy, colectomy, or small bowel resection
• Individuals with diabetes undergoing oral treatment with metformin
• Body mass index \>35 kg/m2
• Persons admitted to a health or social care facility for purposes other than research
• Persons not affiliated with a social security system or beneficiaries of a similar system
• Failure to comply with the exclusion period from another study specified in the national volunteer registry
• Adults subject to legal protection measures (guardian, curator)
• Persons deprived of their liberty by judicial or administrative decision
• Persons who have exceeded the annual compensation amount for participation in research protocols
• Persons with a chronic progressive or advanced disease detectable by clinical examination and laboratory tests that may interfere with the study's evaluation criteria, the judgment of which is left to the discretion of the research team
• Persons with hemiplegia or another form of partial/total paralysis
• Contraindications to metabolic testing: severe coagulation disorder, anemia, difficult and painful venous access in the investigator's judgment
• Chronic constipation or diarrhea
• Taking antibiotics within 15 days prior to the investigations and in the absence of induced digestive disorders (for so-called common antibiotics of the beta-lactam family) or within the month prior to the investigations, at the investigator's discretion (for Augmentin).
• Polypharmacy, including drugs known to affect the microbiota and intestinal transit

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not randomized

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Hospices Civils de Lyon

Study start

Nov 19, 2026 Estimated

Primary completion

Mar 19, 2028 Estimated

Study completion

Mar 19, 2028 Estimated

First posted

Oct 26, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts