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NCT02460783 · ClinicalTrials.gov registry record · NA
Intermittent Calorie Restriction, Insulin Resistance, and Biomarkers of Brain Function
A NA study, sponsored by National Institute on Aging (NIA).
- Completed
- Registry status
- NA
- Development phase
- 129
- Enrollment target
NCT02460783: Completed NA study, sponsored by National Institute on Aging (NIA).
NCT02460783 is a NA study that has completed, run by National Institute on Aging (NIA). The registered enrollment target is 129 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02460783, a NA study, has completed, sponsored by National Institute on Aging (NIA).
- COMPLETED
- Registry status
- NA
- Development phase
- 129 participants
- Enrollment target
Study 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.
Primary Outcome
IRS-1 is an intracellular adaptor molecule that is being recruited and activated by the binding of insulin and insulin-like growth factor to their respective receptors and in insulin resistance (IR) it shows aberrant phosphorylation in serine residues resulting in impaired downstream signal propagation. pS312-IRS-1 is considered an index of brain insulin resistance and a therapeutic response biomarker for interventions targeting brain IR. A decrease in its levels indicates target engagement with
Interventions
- OTHER Boost (R) 5-2 diet
- OTHER Healthy Living Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2015-06-22 |
| Est. Completion | 2022-12-23 |
| Phase | NA |
What the finished NCT02460783 record still lists
NCT02460783 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Boost (R) 5-2 diet is the first listed.
NCT02460783 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02460783 about?
NCT02460783 is a clinical study titled "Intermittent Calorie Restriction, Insulin Resistance, and Biomarkers of Brain Function". 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. ...
What is the current status of trial NCT02460783?
This trial is currently completed. It is a NA study. The enrollment target is 129 participants. The study started on 2015-06-22. Estimated completion is 2022-12-23.
What interventions are being tested in trial NCT02460783?
The interventions under investigation include: Boost (R) 5-2 diet (OTHER), Healthy Living Diet (OTHER).
Who is sponsoring clinical trial NCT02460783?
This trial is sponsored by National Institute on Aging (NIA), which has 131 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02460783's enrollment target sits among peer trials
129 744th of 2000 higher than 1,257 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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