MedTrace Logo

Intermittent Calorie Restriction, Insulin Resistance, and Biomarkers of Brain Function

NCT02460783 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2024-04-02

Study results available
· View outcomes & findings →

Summary

Background:

\- Insulin removes sugar from the blood to use for energy. Insulin resistance means that cells may not respond to insulin normally. It can lead to serious diseases. Researchers want to see how diet affects insulin resistance, weight, and brain chemicals related to Alzheimer s disease.

Objectives:

\- To compare two forms of diet and their effects on insulin resistance and the brain.

Eligibility:

\- Women ages 55 70 with insulin resistance.

Design:

* This study requires 6 clinic visits over 9 12 weeks. Participants must fast before visits.
* Visit 1, screening:
* Medical history, physical exam, and blood and urine tests.
* Participants will get a wrist device to wear for 4 days.
* Visit 2:
* Weight and waist measurement.
* Blood drawn.
* Questionnaires and thinking tests.
* Lumbar puncture. Skin will be numbed and a needle inserted between bones in the back will remove \<TAB\>fluid.
* Participants will drink a nutrition shake. Blood will be taken 12 times over 4 \<TAB\>hours through a thin tube in \<TAB\>the arm.
* Brain MRI. Participants will lie on a table that slides in and out of a cylinder in a strong magnetic field. \<TAB\>They will have a coil on their head and may do tasks.
* Participants will get advice about healthy eating and be randomly put in one of 2 groups. One group will get \<TAB\>nutrition shakes to drink.
* Visits 3 5:
* Weight and waist measurements, vital signs, blood draw, and questionnaires.
* Between visits, participants will get a call or email to check how they are doing.
* Visit 6: Repeat of visit 1.
* Participants will wear the wrist device for 4 more days, have a follow-up contact, then the study is finished.

Conditions

Interventions

OTHER

Boost (R) 5-2 diet

Regular diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days/week. Supplement providing 240 Kcal per shake. Participant takes 2 shakes per calorie restriction day.

OTHER

Healthy Living Diet

Counseling and educational material on diet portion, consistency

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    lead NIH

Principal Investigators

  • Dimitrios I Kapogiannis, M.D. · National Institute on Aging (NIA)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-22
Primary Completion
2022-01-14
Completion
2022-12-23

Countries

  • United States

Study Locations

More Related Trials

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 NCT02460783 on ClinicalTrials.gov