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Behavioural Intervention

Fasting-Mimicking Diet for Apolipoprotein E4

N/A

Recruiting

Led By Mitzi Gonzales, PhD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Carrier of at least one copy of the APOE e4 allele

Male or female, aged 45-65 years at screening

Must not have

History of gastric bypass

Inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to end of study (day 251 +/-7 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a specific diet, designed to mimic the effects of fasting, is safe and effective for middle-aged adults at risk for Alzheimer's disease. Participants will follow the diet for 5

Who is the study for?

This trial is for middle-aged adults who are at higher risk of Alzheimer's because they carry the APOE ε4 gene. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can join.

What is being tested?

The NIBBLE study tests a fasting-mimicking diet (FMD) called FMD1 (LNT22-017-1), which participants follow for 5 days each month over six months. The goal is to see if this diet can improve body and brain health and potentially increase lifespan in those at risk for Alzheimer's.

What are the potential side effects?

Potential side effects were not detailed, but fasting-mimicking diets may cause temporary hunger, fatigue, dizziness, or irritability due to calorie restriction. Long-term effects are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I carry the APOE e4 gene variant.

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I am between 45 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a gastric bypass surgery.

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I have inflammatory bowel disease.

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I have been diagnosed with a significant neurological condition.

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I have had surgery to remove part of my small or large intestine.

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I am currently taking drugs that suppress my immune system.

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I am not pregnant, breastfeeding, or trying to get pregnant.

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I have diabetes or take medication for it.

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I have lost more than 5% of my weight recently, used weight loss medication, or joined a weight loss program in the last 3 months.

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I have smoked or used tobacco in the last 3 months.

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I have not had cancer, except for non-melanoma skin cancer, in the last year.

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I have been diagnosed with mild cognitive impairment or dementia and am on Alzheimer's medication. My MoCA score is below 23.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to end of study (day 251 +/-7 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to end of study (day 251 +/-7 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to end of study (day 251 +/-7 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Investigate the impact of the FMD intervention on cerebral blood flow relative to normal diet

Secondary study objectives

Evaluate the safety of a six-month FMD intervention

Investigate the impact of the FMD intervention on cognition relative to normal diet

Other study objectives

Evaluate the efficacy of FMD relative to normal diet for modulating autophagic flux

Evaluate the efficacy of FMD relative to normal diet for modulating metabolic parameters

Examine the impact of FMD on systemic markers of inflammation through physiological paramaters.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FMD - InterventionExperimental Treatment1 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.

Group II: Normal Diet - ControlActive Control1 Intervention

Participants in the normal diet group will be asked to consume their regular diet.

0 / 13Eligibility criteria met