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Calorie Restriction and Brain Function in Mild Cognitive Impairment

NCT03872375 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-03-31

No results posted yet for this study

Summary

Problems with blood sugar metabolism (i.e., metabolic dysfunction) progressively develop through old age, which is primarily due to obesity and lack of physical activity. Metabolic dysfunction increases the risk for Alzheimer's disease (AD) and negatively impacts memory and related brain function. There is intense interest in developing interventions, particularly non-drug therapies, to combat AD. Recent clinical trials have found that intranasal insulin, which facilitates glucose metabolism in the brain, is able to maintain memory in participants with Mild Cognitive Impairment (MCI), the precursor to AD. While intranasal insulin is a useful, proof-of-concept intervention, it does not affect visceral fat mass and therefore metabolic dysfunction will persist in a given person.

The investigators wish to engage participants with MCI in intermittent calorie restriction (CR), to reduce metabolic dysfunction and improve glucose metabolism. Intermittent calorie restriction in this case refers to eating whatever one wants for 5 days, followed by 2 consecutive days of consuming 530 calories via one protein shake with sufficient nutrients to sustain the person. This results in reliable weight loss, which itself improves glucose metabolism in the body and has a wealth of other benefits. (It should be mentioned here that weight maintenance has been shown in studies when participants restrict to 1 day/week).

Conditions

Interventions

DIETARY_SUPPLEMENT

Meal-Replacement Therapy

The meal replacement shake, consumed once per day on two consecutive days, will over a given week lead to negative energy balance and induce weight loss.

BEHAVIORAL

Dietary Counseling

A Registered Dietitian of Nutrition will provide consultation on how to induce moderate weight loss.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Iowa State University

    lead OTHER

Principal Investigators

  • Auriel A Willette · Iowa State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-08
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03872375 on ClinicalTrials.gov