Ignite Creation Date:
2024-05-06 @ 7:04 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02460783
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2015-05-30
Brief Title:
Intermittent Calorie Restriction Insulin Resistance and Biomarkers of Brain Function
Sponsor:
National Institute on Aging NIA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Intermittent Calorie Restriction Insulin Resistance and Biomarkers of Brain Function
Status:
COMPLETED
Status Verified Date:
2023-11-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 TABfluid
Participants will drink a nutrition shake Blood will be taken 12 times over 4 TABhours through a thin tube in TABthe arm
Brain MRI Participants will lie on a table that slides in and out of a cylinder in a strong magnetic field TABThey 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 TABnutrition 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
- 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 TABfluid
Participants will drink a nutrition shake Blood will be taken 12 times over 4 TABhours through a thin tube in TABthe arm
Brain MRI Participants will lie on a table that slides in and out of a cylinder in a strong magnetic field TABThey 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 TABnutrition 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
Detailed Description:
Being overweight or obese can cause insulin resistance IR which is defined as reduced responsiveness to insulin by the cells of various tissues or organs IR at midlife increases the risk of developing Alzheimer s disease AD We recently discovered novel biomarkers of brain IR altered Tyr and Ser phosphorylated forms of insulin receptor substrate 1 IRS-1 in plasma exosomes enriched for neuronal origin Moreover IR is associated with AD biomarkers including deficits in resting state brain activity and cognitive performance Calorie restriction is defined as consuming fewer calories than what is considered normal without a lack of nutrients A certain type of calorie restriction in which one consumes 500-600 calories a day for two consecutive days followed by non-restricted eating for 5 days 5-2 CR has been shown to lower peripheral insulin resistance effectively Effects of CR and lowering peripheral IR on brain IR and cognition are unknown The goal of this exploratory pilot study is to provide proof-of-concept that 5-2 CR at midlife can reverse brain IR lower peripheral IR improve cognitive performance and increase brain activation at rest and during tasks Specifically we will study the effects of 8 weeks of 5-2 CR versus a control dietary intervention on brain and peripheral IR memory and executive function resting state default mode network activity brain metabolism and AD biomarkers Forty overweight to obese women and men between 55 and 70 years of age will be randomized 11 into 5-2 CR and control groups In the 5-2 CR group participants will be offered healthy living dietary counseling at baseline which they will be instructed to implement for five daysweek For each of the other two consecutive daysweek they will consume two shakes Boost CWI Medical providing a total of 480 Kcalday In the control group participants will be offered healthy living dietary counseling at baseline which they will be asked to implement for every day of the week Participants will undergo screening including a history and physical examination calculation of Body Mass Index BMI which must be greater than or equal to 27 and a blood draw for insulin and glucose to determine whether they have insulin resistance If participants meet eligibility criteria they will continue with a baseline visit involving anthropometric measures questionnaires tests of cognitive function brain MRI blood draws for plasma and peripheral blood mononuclear cells and lumbar puncture for cerebrospinal fluid biomarkers of AD After 8 weeks we will collect the same measures To assess and reinforce compliance with their respective diet participants will come into the clinic every 2 weeks to discuss compliance measure their body weight and perform blood draws for measurement of ketones to objectively confirm energy restriction for the 5-2 CR group We will also contact participants every week to further ensure compliance To assess the effects of the diets on physical activity participants will be asked to wear an accelerometer for 96 hours before and after they are on the diet
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15-AG-0123 | None | None | None |