Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06070194

Cardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Pennington Biomedical Research Center · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTime restricted eating (TRE)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.

Timeline

Start date
2023-12-05
Primary completion
2028-06-30
Completion
2028-06-30
First posted
2023-10-06
Last updated
2026-02-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06070194. Inclusion in this directory is not an endorsement.