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Trials / Completed

CompletedNCT04144426

Meal Schedule Effects on Circadian Energy Balance in Adults

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
Vanderbilt University · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Accepted

Summary

This study will test will how eating on a particular daily schedule may effect energy, weight gain or loss, and body temperature.

Detailed description

Although there have been a large number of studies in humans on the effects of food intake at night, very few studies directly address the hypothesis that inappropriately phased eating or snacking (i.e., at night) in humans disrupts metabolism and respiratory quotient (RQ) patterns and there are no studies that we are aware of that directly measure circadian clock phase relative to timing of food intake while evaluating metabolism. This may be critical, because it is well established that the timing of food intake can also modulate circadian clock phase. Hypothesis: Food consumption in the subjective night (e.g., 20:00 - 02:00) will result in a different circadian metabolic profile measured by RQ) than food consumed in the subjective day. Aim 1: To determine if there are daily rhythms of switching between lipid and carbohydrate metabolism in humans that are altered by the timing of food intake. Aim 2: To determine if timing of food intake results in "internal desynchronization" between the metabolic rhythms (RQ) and the rhythm in core body temperature (a marker of central circadian phase). Aim 3: To determine if body composition has measurable impact on the circadian regulation of metabolism. In this study we will test human subjects in a specially designed whole-room indirect calorimeter where energy expenditure and RQ will be monitored by indirect calorimetry continuously over 56 hours. Circadian phase and amplitude will be assessed by continuously recording the core body temperature rhythm using the Vital Sense Integrated Physiological Monitoring System in which subjects swallow a telemetry capsule that transmits core body temperature to a data acquisition module. In consultation with a nutritionist at Vanderbilt, we will use a cross-over design in which daily diets have the same caloric and nutritional value but in which the subjects consume the calories that would normally be breakfast as snacks consumed in the late-evening.

Conditions

Interventions

TypeNameDescription
BEHAVIORALNormal dietParticipants will receive either a 2000 calorie or a 2500 calorie diet at normal meal times
BEHAVIORALModified dietParticipants will receive either a 2000 calorie or a 2500 calorie diet with a single meal shift, breakfast is moved to an hour before bedtime.

Timeline

Start date
2015-10-08
Primary completion
2017-05-26
Completion
2017-05-26
First posted
2019-10-30
Last updated
2019-10-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04144426. Inclusion in this directory is not an endorsement.