Health TrialsbyHealthPanel

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

ConditionSleep Deprivation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorPennington Biomedical Research Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 18-45 years

BMI: 25-35 kg/m2

Habitual sleep duration: ≤6.5 h/night

Habitual eating period: >14h/day

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Time restricted eating (TRE)

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Time restricted eating (TRE)Experimental treatment 1 intervention
Group B: Habitual eating durationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 4 weeks
2

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.

Time frame
Baseline to 4 weeks

Secondary outcomes

1

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.

Time frame
Baseline to 4 weeks
2

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.

Time frame
Baseline to 4 weeks

Other outcomes

1

Change in clock time for dim light melatonin onset

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
2

Change in clock time for dim light melatonin offset

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
3

Change in melatonin area under the curve (AUC)

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pennington Biomedical Research Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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