Intermittent Calorie Restriction, Insulin Resistance, and Biomarkers of Brain Function
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02460783|
Recruitment Status : Recruiting
First Posted : June 2, 2015
Last Update Posted : December 31, 2018
- 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.
- To compare two forms of diet and their effects on insulin resistance and the brain.
- Women ages 55 70 with insulin resistance.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Obesity Diabetes Mellitus||Dietary Supplement: Boost A Behavioral: Healthy Living Diet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intermittent Calorie Restriction, Insulin Resistance, and Biomarkers of Brain Function|
|Study Start Date :||May 30, 2015|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||July 1, 2019|
Experimental: 5-2 CR
Healthy living diet for 5 days/week;
Dietary Supplement: Boost A
Supplement providing 530 Kcal/Bottle
Active Comparator: Healthy Living
Healthy living diet for 7 days/week
Behavioral: Healthy Living Diet
Counseling and educational material on diet portion, consistency
- Exosomal p-S312-IRS-1/p-panY-IRS-1 ratio (index of brain insulin resistance) [ Time Frame: 0, 8 weeks ]
- Hormones (GLP-1, insulin) during a mixed [ Time Frame: 0, 8 weeks ]
- Anthropometric measures (weight, waist) [ Time Frame: 0, 2, 4, 6, 8 weeks ]
- Measure: CSF, plasma BDNF [ Time Frame: 0, 8 weeks ]
- Cognitive performance (Examiner, Memory) [ Time Frame: 0, 8 weeks ]
- Mood, energy, concentration, etc. symptom [ Time Frame: 0, 2, 4, 6, 8 weeks ]
- Si and HOMA-IR (indices of peripheral insulin resistance) [ Time Frame: 0, 8 weeks ]
- Lipid panel, uric acid [ Time Frame: 0, 8 weeks ]
- MRS metabolites [ Time Frame: 0, 8 weeks ]
- fMRI activation to food preference task [ Time Frame: 0, 8 weeks ]
- fMRI activation to Stroop [ Time Frame: 0, 8 weeks ]
- CSF, plasma AD biomarkers (A(SqrRoot) <=42,p181Tau) [ Time Frame: 0, 8 weeks ]
- Cytokines: IL-6, IL-8, IL-12, IL-23 [ Time Frame: 0, 8 weeks ]
- Physical activity (Accelerometry) [ Time Frame: 0, 8 weeks ]
- DNA methylation [ Time Frame: 0, 2, 4, 6, 8 weeks ]
- Measure: Exosomal proteins and mRNA [ Time Frame: 0, 8 weeks ]
- ROS, AGES [ Time Frame: 0, 8 weeks ]
- Resting fMRI [ Time Frame: 0, 8 weeks ]
- Gene expression [ Time Frame: 0, 2, 4, 6, 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460783
|Contact: Kristy L Kessler, R.N.||(410) firstname.lastname@example.org|
|Contact: Dimitrios I Kapogiannis, M.D.||(410) email@example.com|
|United States, Maryland|
|National Institute of Aging, Clinical Research Unit||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Dimitrios I Kapogiannis, M.D.||National Institute on Aging (NIA)|