RightFit
Not yet recruitingPhase 1 / Phase 2

A Nutritional and Pharmacological Intervention for Body, Brain, and Longevity Effects (NIBBLE)

A Nutritional and Pharmacological Intervention for Body, Brain, and Longevity Effects (NIBBLE) - A Randomized Open-label Intervention of the Fasting-mimicking Diet (FMD) and Rapamycin (NIBBLE)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks, 5 days
  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants randomly assigned to the rapamycin and placebo groups will take 1 mg of rapamycin or a matched placebo pill daily for approximately 8 weeks."
  • "Participants assigned to the FMD arm will adhere to the diet for 5 days over three cycles for a period of 8 weeks."
  • "Participants randomized to the rapamycin group will receive 1 mg rapamycin daily for 8 weeks and those in the placebo arm will take one matched placebo pill daily for 8 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a diet that mimics fasting and a low daily dose of rapamycin against a placebo pill with no active drug. It checks safety, how well people can follow treatment, and early signs of benefit over about 8 weeks. It is for adults ages 45–65 who carry the APOE e4 gene variant, which raises the risk of Alzheimer's disease.

The study aims to evaluate the safety, feasibility, and preliminary efficacy of the fasting-mimicking diet (FMD) or low-dose daily rapamycin treatment relative to a matched placebo control group when administered over 8 weeks in middle-aged adults at elevated risk for Alzheimer's disease due to the apolipoprotein (APOE) ε4 allele. Participants randomly assigned to the FMD intervention will adhere to FMD for 5-days over three cycles for a period of approximately 8 weeks. Participants randomly assigned to the rapamycin and placebo groups will take 1 mg of rapamycin or a matched placebo pill daily for approximately 8 weeks.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign and date a form agreeing to join the study.
  • Be willing to follow all study steps and stay available for the whole study.
  • Be 45–65 years old at screening.
  • Have at least one copy of the APOE e4 gene variant.
  • Have a body mass index (BMI), a measure of weight compared with height, of 20–39.
  • Have taken the same medicines on a stable schedule for at least 3 months.
  • For women: have gone through menopause or use highly effective birth control.

Who can't join

  • A health condition that study staff believe makes joining unsafe or may affect study results; liver, kidney, heart, or lung disease; active cancer or cancer within the past year, except non-melanoma skin cancer.
  • Significant depression or anxiety; a serious mental health condition, such as schizophrenia, bipolar disorder, or an eating disorder; a major brain or nerve condition, such as multiple sclerosis, epilepsy, Parkinson's disease, or major stroke.
  • Mild cognitive impairment (memory or thinking problems), dementia, use of an approved Alzheimer's drug, or a MoCA thinking-test score below 23; inability to have an MRI scan, such as due to fear of tight spaces or a heart pacemaker.
  • A special diet now or within the past 3 months, such as keto, paleo, fasting, raw food, or vegan; food allergies or special food needs that prevent eating study foods; animal allergies or asthma triggered by animals.
  • Diabetes with HbA1c above 6.5% or use of diabetes drugs; past gastric bypass surgery, inflammatory bowel disease, or removal of part of the bowel; recent weight loss over 5%, weight-loss drugs, or a weight-loss program within 3 months.
  • Use of drugs that weaken the immune system, affect the liver enzyme CYP3A4, or change blood flow in the brain; untreated blood fats called triglycerides above 300 mg/dL; blood pressure above 160 for the top number or 100 for the bottom number.
  • Pregnant, breastfeeding, trying to become pregnant, or using hormone replacement therapy.
  • Alcohol dependence, defined here as more than 2 drinks daily for women or 3 for men; smoking now or tobacco use within the past 3 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 45-65 years at screening 4. Carrier of at least one copy of the APOE e4 allele 5. BMI 20-39kg/m2 (inclusive) at screening 6. On a stable medication regimen for at least 3 months. 7. For females: Post-menopausal status or use of highly effective contraception. Exclusion Criteria: * Has any medical disease or condition that, in the opinion of the principal investigator (PI) or appropriate study personnel, precludes study participation\* (\*Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial); * Significant depression (PHQ-9\>9) or generalized anxiety (GAD-7\>9) * Diagnosis of a significant neurological condition such as multiple sclerosis, epilepsy, Parkinson's disease, major stroke * Contraindications to MRI such as claustrophobia, cardiac pacemaker, etc. * Current adherence or adherence within the past 3 months to a specialized diet (e.g. ketogenic, paleo, intermittent fasting, raw food, vegan) * Food allergies (e.g. dairy, eggs, fish/shellfish, peanuts, tree nuts, soy, wheat, sesame, corn) * Diagnosis of mild cognitive impairment or dementia; use of an FDA-approved medication for Alzheimer's disease; MoCA\<23 * Diabetes (hbA1c \>6.5%) or anti-diabetic medications * History of gastric bypass; * Inflammatory bowel disease * Small or large bowel resection * Subjects with recent weight loss (\>5%), use of weight loss medication, participated in a weight loss program in the past 3 months * Use of immune suppression drugs; * Contraindication for study foods (special food needs and allergy); * Women who are pregnant, lactating, or trying to conceive * Women who are on hormone replacement therapy * Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men) * Current smoker or tobacco use within 3 months. * Active malignant cancer or history of malignancy within the last 1 yea1s (except non-melanoma skin cancer) * Serious psychiatric disorders such as schizophrenia, bipolar disorder, eating disorders * Persons with allergy to animal dander or animal-instigated asthma * Required use of drugs that affect cytochrome P450 3A4 or alter cerebral blood flow (see Appendix 1 for tables of excluded medications) * Current or chronic liver, kidney, cardiac, or pulmonary diseases * Untreated hypertriglyceridemia (fasting triglycerides \> 300 mg/dl) * Poorly controlled blood pressure (systolic BP \> 160 or diastolic BP \> 100 mmHg

Study sites (1)

CA