Mild Cognitive Impairment study: Dietary Intervention
Official title Time Restricted Eating in Alzheimer's Disease
ClinicalTrials.gov ID: NCT06429124
What this study is testing
- What it's testing
- This study checks if a specific eating schedule is safe and doable for people with mild memory problems. It also looks at how this diet affects thinking skills and health markers in the blood.
- Who it's for
- Adults who have been diagnosed with mild cognitive impairment, which is a stage of memory loss between normal aging and dementia.
- What's involved
- Participants will follow a diet where they fast for 16 hours and eat only during an 8-hour window, five days a week. They will also take memory tests, have blood drawn, and fill out questionnaires about their well-being.
- Time commitment
- The study lasts 3 months and requires visits at the start and at the end to complete tests and assessments.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 89
You may be able to join if
- Male or Female outpatients 55-89 years of age.
- Meet Mayo Clinic Criteria for MCI.
- If taking medications that may affect one or more study outcome measures(such as donepezil and memantine),the participant must be on a stable dose...
- A body mass index ≥18.5 and \<40.0 kg/m2.
- Access to the internet through computer or smartphone.
You likely can't join if
- Diabetes mellitus that requires insulin treatment or is not well managed.
- An eating disorder.
- A contraindication to time-restricted eating.
- Daily eating window \<11 hours/day on ≥3 days/week.
- MMSE score ≤9 or patients diagnosed with severe dementia by a clinician.
- In the opinion of the investigator, participation would not be in the best interest of the subject.
See the full eligibility criteria
- Male or Female outpatients 55-89 years of age.
- Meet Mayo Clinic Criteria for MCI.
- If taking medications that may affect one or more study outcome measures(such as donepezil and memantine),the participant must be on a stable dose for at least the preceding 3 months.
- A body mass index ≥18.5 and \<40.0 kg/m2.
- Access to the internet through computer or smartphone.
- Must have a collateral informant/study partner(e.g. spouse or adult child) who has significant direct contact with the patient and who is willing to accompany the patient to specified clinic visits and be available for...
- An education level \> 8 years.
- A proficiency in speaking and reading English or having a family member who is proficient in reading and speaking English and is willing to serve as a translator.
- Vision and hearing must be sufficient to comply with study procedures.
- Diabetes mellitus that requires insulin treatment or is not well managed.
- An eating disorder.
- A contraindication to time-restricted eating.
- Daily eating window \<11 hours/day on ≥3 days/week.
- MMSE score ≤9 or patients diagnosed with severe dementia by a clinician.
- In the opinion of the investigator, participation would not be in the best interest of the subject.
- Taking prescription medications twice a day that need to be taken with food.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.