Recruiting core Pennington
Baton Rouge, Louisiana, 70808, United States
Location status: Recruiting
NCT Number: NCT06070194
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
Baton Rouge, Louisiana, 70808, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline to 4 weeks
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
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
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
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
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
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
Change in AUC from melatonin onset to offset from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.
Contact information is provided by the study sponsor or research team.
Pennington Biomedical Research Center
Other
Acronym: CRISP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06180837
Behavior, Behavior, Animal
Salt Lake City, Utah, United States
View Trial DetailsNCT00721019
Diabetes Mellitus, Diabetes Mellitus, Type 2
Chicago, Illinois, United States
View Trial DetailsNCT00724087
Diabetes Mellitus, Diabetes Mellitus, Type 2
Chicago, Illinois, United States
View Trial DetailsNCT06075914
Dyssomnias, Mental Disorders
Columbus, Ohio, United States
View Trial Details