Back to resultsCardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period (CRISP)
Primary Purpose
Sleep Deprivation
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time restricted eating (TRE)
Sponsored by
About this trial
This is an interventional basic science trial for Sleep Deprivation focused on measuring eating duration, short sleep duration, time-restricted eating, blood pressure, insulin resistance
Eligibility Criteria
Inclusion Criteria: Age: 18-45 years BMI: 25-35 kg/m2 Habitual sleep duration: ≤6.5 h/night Habitual eating period: >14h/day Absence of chronic health conditions including hypertension (defined as systolic clinical BP of >140 or diastolic BP of >90 mmHg or use of BP lowering drugs), dyslipidemia (defined as LDL >190mg/dL or Triglycerides >400 mg/dL or use of lipid lowering medications), diabetes (defined as fasting glucose >126 mg/dL and /or HbA1C >6.5%, or use of glucose lowering medication), and cardiovascular disease. However, individuals with prehypertension, and/or prediabetes will be allowed to participate. Individuals with seasonal allergies will also be included. Women of child-bearing age will be allowed to participate if they agree to use acceptable birth control during the study period. Must be able to provide written informed consent. Ability to follow the prescribed eating duration and maintain habitual diet, sleep and physical activity. Use of certain mediations will be allowed including birth control, second generation antihistamines, antacids, acne-related ointments etc. Exclusion Criteria: Irregular sleep habits / night shift / rotating shift work in past 1 month. Frequent travel related jet lag. Pregnant/ breast-feeding/ history of irregular menstrual cycles. Sleep disorders such as insomnia (defined as Insomnia Severity Index score ≥15), and sleep apnea (overnight oximetry defined oxygen desaturation index of >10 events/h of sleep). Presence of excessive daytime sleepiness (defined as Epworth Sleepiness Scale score >10). Recent changes in body weight (≥5%) within 3 months. Uncontrolled depression and /or anxiety, history of psychosis or bipolar disorder. Uncontrolled depression and/or depression is defined as PHQ-9 score of ≥15 or a positive response for suicidal thoughts (Q9 of the PHQ-9 - any response other than not at all). Any medication or condition that, in the opinion of the medical investigator, could interfere with the study outcomes or put the subject at risk by participating in the study. Blood or plasma donation during the past 2 months.
Sites / Locations
- Recruiting core Pennington
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Time restricted eating (TRE)
Habitual eating duration
Arm Description
Subjects randomized to this arm will be asked to follow an 8h eating duration/day for 4 weeks.
Subjects randomized to this arm will be asked to continue habitual eating duration of >14h/day for 4 weeks.
Outcomes
Primary Outcome Measures
Change in 24h mean arterial blood pressure (MAP)
Change in 24h MAP from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.
Change in insulin resistance
Change in insulin resistance from pre-intervention to end-intervention. Insulin resistance will be determined by standard 3h mixed meal tolerance test and calculated as ratio of incremental area under the curve values for insulin and glucose. Difference between habitual eating period and TRE will be evaluated.
Secondary Outcome Measures
Change in 24h systolic blood pressure (SBP)
Change in 24h SBP from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.
Change in postprandial glycemic excursion
Change in postprandial glycemic excursion from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.
Full Information
NCT ID
NCT06070194
First Posted
September 30, 2023
Last Updated
October 5, 2023
Sponsor
Pennington Biomedical Research Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT06070194
Brief Title
Cardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period
Acronym
CRISP
Official Title
Cardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 4, 2023 (Anticipated)
Primary Completion Date
June 30, 2028 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Short sleep duration confers high cardiovascular and metabolic risk, but lifestyle factors and molecular mechanisms that contribute to increased blood pressure and poor glucose control during short sleep are not completely understood. Habitual short sleepers are constantly eating, the proposed studies will evaluate if this behavior contributes to heightened cardiovascular and metabolic risk. The study will evaluate if restricted eating duration (8 hours/day) could improve cardiovascular and metabolic health in habitual short sleepers.
Detailed Description
Short sleep duration is associated with increased cardiovascular and metabolic risk with consequent increased cardiovascular mortality. Increasing sleep duration mitigates the metabolic impairment, but alternate strategies to reduce cardiometabolic risk in habitual short sleepers are lacking. This is especially important when increasing sleep duration is unsuccessful. Unfortunately, the underlying mechanisms through which shortened sleep contributes to metabolic detriments are not completely understood. This hinders the development of alternate strategies for cardiovascular prevention in short sleepers. However, a widespread factor potentially underlying metabolic dysfunction in short sleepers seems to be circadian misalignment (decreased and delayed melatonin secretion) partly resulting from mistimed eating. Importantly, eating behavior may be targeted to improve metabolism in short sleepers. Specifically, limiting the daily eating period as shown by the many recent interventions of time restricted eating (TRE) may potentiate circadian alignment (melatonin rhythms) and improve metabolism in habitual short sleepers.
The goal of the study is to examine the metabolic and circadian effects of eating duration in habitual short sleepers. The investigators propose a two-group, parallel arm study during which participants will be randomized to either continue with habitual >14h/day (extended) or restricted 8h/day (TRE) eating duration. The overarching hypothesis is that extended eating duration contributes to high blood pressure (BP), insulin resistance (IR), and a decreased and delayed melatonin secretion in habitual short sleepers. Therefore, TRE will reduce BP, IR along with an increased and earlier onset of melatonin secretion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
eating duration, short sleep duration, time-restricted eating, blood pressure, insulin resistance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Time restricted eating (TRE)
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will be asked to follow an 8h eating duration/day for 4 weeks.
Arm Title
Habitual eating duration
Arm Type
No Intervention
Arm Description
Subjects randomized to this arm will be asked to continue habitual eating duration of >14h/day for 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Time restricted eating (TRE)
Intervention Description
Subjects randomized to this arm will be asked to follow an 8h eating duration/day for 4 weeks. Participants will be asked to continue habitual sleep patterns.
Primary Outcome Measure Information:
Title
Change in 24h mean arterial blood pressure (MAP)
Description
Change in 24h MAP from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.
Time Frame
Baseline to 4 weeks
Title
Change in insulin resistance
Description
Change in insulin resistance from pre-intervention to end-intervention. Insulin resistance will be determined by standard 3h mixed meal tolerance test and calculated as ratio of incremental area under the curve values for insulin and glucose. Difference between habitual eating period and TRE will be evaluated.
Time Frame
Baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Change in 24h systolic blood pressure (SBP)
Description
Change in 24h SBP from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.
Time Frame
Baseline to 4 weeks
Title
Change in postprandial glycemic excursion
Description
Change in postprandial glycemic excursion from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.
Time Frame
Baseline to 4 weeks
Other Pre-specified Outcome Measures:
Title
Change in clock time for dim light melatonin onset
Description
Change in clock time for dim light melatonin onset from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.
Time Frame
Baseline to 4 weeks
Title
Change in clock time for dim light melatonin offset
Description
Change in clock time for dim light melatonin offset from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.
Time Frame
Baseline to 4 weeks
Title
Change in melatonin area under the curve (AUC)
Description
Change in AUC from melatonin onset to offset from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.
Time Frame
Baseline to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: 18-45 years
BMI: 25-35 kg/m2
Habitual sleep duration: ≤6.5 h/night
Habitual eating period: >14h/day
Absence of chronic health conditions including hypertension (defined as systolic clinical BP of >140 or diastolic BP of >90 mmHg or use of BP lowering drugs), dyslipidemia (defined as LDL >190mg/dL or Triglycerides >400 mg/dL or use of lipid lowering medications), diabetes (defined as fasting glucose >126 mg/dL and /or HbA1C >6.5%, or use of glucose lowering medication), and cardiovascular disease. However, individuals with prehypertension, and/or prediabetes will be allowed to participate.
Individuals with seasonal allergies will also be included.
Women of child-bearing age will be allowed to participate if they agree to use acceptable birth control during the study period.
Must be able to provide written informed consent.
Ability to follow the prescribed eating duration and maintain habitual diet, sleep and physical activity.
Use of certain mediations will be allowed including birth control, second generation antihistamines, antacids, acne-related ointments etc.
Exclusion Criteria:
Irregular sleep habits / night shift / rotating shift work in past 1 month.
Frequent travel related jet lag.
Pregnant/ breast-feeding/ history of irregular menstrual cycles.
Sleep disorders such as insomnia (defined as Insomnia Severity Index score ≥15), and sleep apnea (overnight oximetry defined oxygen desaturation index of >10 events/h of sleep).
Presence of excessive daytime sleepiness (defined as Epworth Sleepiness Scale score >10).
Recent changes in body weight (≥5%) within 3 months.
Uncontrolled depression and /or anxiety, history of psychosis or bipolar disorder.
Uncontrolled depression and/or depression is defined as PHQ-9 score of ≥15 or a positive response for suicidal thoughts (Q9 of the PHQ-9 - any response other than not at all).
Any medication or condition that, in the opinion of the medical investigator, could interfere with the study outcomes or put the subject at risk by participating in the study.
Blood or plasma donation during the past 2 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prachi Singh, PhD
Phone
225-762-3151
Email
prachi.singh@pbrc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prachi Singh, PhD
Organizational Affiliation
Pennington Biomedical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Recruiting core Pennington
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period
We'll reach out to this number within 24 hrs