A Nutritional Intervention for Body, Brain, and Longevity Effects (NIBBLE) - A Randomized Open-label Intervention of the Fasting-mimicking Diet (FMD)
概览
- 阶段
- 不适用
- 干预措施
- FMD1 (LNT22-017-1)
- 疾病 / 适应症
- Cerebral Blood Flow
- 发起方
- Cedars-Sinai Medical Center
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluate the safety of a six-month FMD intervention
- 状态
- 尚未招募
- 最后更新
- 2个月前
概览
简要总结
The study aims to evaluate the safety, feasibility, and preliminary efficacy of six-month fasting-mimicking (FMD) relative to Dietary Guidance intervention 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 consume a FMD for 5-days each month over a period of 6-months.
详细描述
Participants assigned to the FMD arm will adhere to the diet for 5 days a month over a period of 6-months. The FMD diet is produced by L-Nutra and provides 1100 kcals on the day 1 and 800 kcals on days 2-5. The diet consists of ingredients which are Generally Regarded As Safe (GRAS) selected for their fasting mimicking properties. The Dietary Guidance Group will receive recommendations based on the Harvard Healthy Eating Plate. The overarching hypothesis of the study is that FMD relative to dietary guidance will be safe and well-tolerated. It is also hypothesized that FMD will be associated with increases in cerebral blood flow. . This is a phase 2 single-site trial with a randomized, open label, parallel assignment design. To minimize bias, individuals evaluating the cognitive, research lab, and MRI outcomes will be blinded to the assigned intervention group. The study will enroll 40 participants who will be randomized 1:1 to the fasting-mimicking diet (FMD) intervention versus the Dietary Guidance group with stratification for age and sex. The intervention period is 6-months. Study visits 2-7 occur the day after the participant completes five days of FMD for that cycle if assigned to the FMD group. Visits 2, 3, 5, and 6 will be completed via phone or secure video platform. The intervention period is followed by a 3-month observational follow-up period for both groups. The study design will enable preliminary investigations of the efficacy of FMD relative to the Dietary Guidance group for cognition, ADRD blood biomarkers, epigenetic clock, and brain structure in function in middle-aged adults at elevated risk for Alzheimer's disease due to the APOE e4 genotype. As diet requires volitional activity, the study participants cannot be blinded. To minimize bias, the investigators evaluating cognitive, research labs, and MRI outcomes will be blinded to group assignments.
研究者
Mitzi Gonzales
Principal Investigator
Cedars-Sinai Medical Center
入排标准
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 45-65 years at screening
- •Carrier of at least one copy of the APOE e4 allele
- •BMI 20-39kg/m2 (inclusive) at screening
- •On a stable medication regimen for at least 3 months.
排除标准
- •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
研究组 & 干预措施
FMD - Intervention
Participants in the FMD group will be asked to refrain from consuming any calorie-containing foods or drinks other than the provided study foods/drinks during the designated intervention days each month.
干预措施: FMD1 (LNT22-017-1)
Dietary Guidance
The Dietary Guidance Group will receive nutrition recommendations based on the Harvard Healthy Eating Plate.
干预措施: Dietary Guidance
结局指标
主要结局
Evaluate the safety of a six-month FMD intervention
时间窗: From pre- to post-treatment (Day 165 +/-8 days)
Endpoint: Number of adverse events in the intervention group relative to the Dietary Guidance group
次要结局
- Investigate the impact of the FMD intervention on cerebral blood flow relative to the Dietary Guidance Group(From pre- to post-treatment (Day 165 +/-8 days))
- Investigate the impact of the FMD intervention on cognition relative to the Dietary Guidance group.(From pre- to post-treatment (Day 165 +/-8 days))