Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07354620
Eligibility Criteria:
Inclusion Criteria:
* Subjects will be healthy and of any sex, any ethnicity, and any age from 50 to 80
* "Healthy" subjects will be defined as a real-world cohort of individuals likely to utilize such an intervention
* May be on other medications if they do not conflict with rapamycin.
* All medical conditions need to be stable and well controlled.
* Willing and able to provide informed consent
Exclusion Criteria:
* Severe illnesses, for which rapamycin may cause harm. This would not be limited to but include active neoplastic or auto-immune disease. If patients have a previous history of cancer or auto-immune disease, the risks and benefits and possible adverse reactions will be discussed at time of consent
* History of organ transplant
* Any unstable medical condition that would interfere with the study
* Hepatic impairment. Note: Patients with elevated liver enzymes and low albumin, will be further screened for hepatic impairment. Elevated liver enzymes \< 2x upper limit of normal will not be considered hepatic impairment.
* Renal impairment, indicated by a serum creatinine \> 1.4 mg/dL
* Anemia indicated by a hemoglobin \< 12 g/dL
* Platelets \< 80,000/cumm,
* ANC \< 1,000 / cumm
* Total WBC \< 3,000/cumm
* Pregnancy or breastfeeding or woman of childbearing potential with inadequate contraception
* Unstable mental illness
* A condition where rapamycin may interfere deleteriously with a medication that is taken by a potential subject
* Currently prescribed with high dose CYP3A4 pathway medications such as verapamil \> 240 mg; simvastatin \>40 mg, lovastatin \> 40 mg or atorvastatin \> 40 mg daily. Poor GI motility as demonstrated by delayed gastric emptying on a radionucleotide isotope scan.
* Intercurrent severe infection at initiation of study drug
* Any and all other reasons that the investigator may determine that the participant is not suitable for study enrollment.
* History of or active eating disorders as deemed by PI.
* BMI lower than 18.5
* Any medication that may dangerously lower glucose while on the FMD. This will include insulin, sulfonylureas (glyburide; glipizide); Thiazolidenediones ( eg piogltazone; rosiglitazone); GLP1 drugs (semaglutide; tirzepatide);; DPP-4 inhibitors (eg sitagliptin; saxagliptin); Alpha -glucosidase inhibitors (acarbose; miglitol). Patients on SGLT2 inhibitors (empagliflozin; canagliflozin) and Metformin (glucophage) may be included in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT07354620
Study Brief:
Protocol Section:
NCT07354620