Meal Schedule Effects on Circadian Energy Balance in Adults

Not Applicable

Completed

• Conditions: Metabolism; Circadian Rhythms
• Interventions: Behavioral: Normal diet; Behavioral: Modified diet

• Registration Number: NCT04144426
• Lead Sponsor: Vanderbilt University

Brief 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.

Study Timeline

• Study Start: 2015-10-08
• Primary Completion: 2017-05-26
• Study Completion: 2017-05-26
• Status Verified: 2019-10
• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-28
• Last Update Submitted: 2019-10-28
• Study First Posted: 2019-10-30
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Be able to understand the study, provide written informed consent (in English), and be able to fill out the questionnaire
• Be male or female older than 18 years of age;
• Have a normal BMI (20-25) or be obese (BMI more than 30);
• Have a normal basal glucose level (70-100 mg/dL)
• If female of childbearing potential, have a negative pregnancy test on study day;

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Exclusion Criteria

• Be pregnant or lactating;
• Have known sleep, metabolic (e.g., diabetes), or gastro-intestinal disorders except obesity;
• Had alcohol less than 24 hours before admission;
• Require assistance with activities of daily living;
• Have difficulty swallowing
• Be unable to complete a food and sleep diary
• Be smokers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Modified diet then normal diet.	Normal diet	Participates in the modified diet skipped breakfast, had lunch at 12:30 PM, dinner at 5:45 PM, and a breakfast equivalent snack at 10:00 PM.Participates in the normal diet will receive 3 meals each day, breakfast at 8:00 AM,lunch at 12:30 PM and dinner at 5:45 PM.
Normal diet then modified diet	Normal diet	Participates in the normal diet will receive 3 meals each day, breakfast at 8:00 AM,lunch at 12:30 PM and dinner at 5:45 PM. Participates in the modified diet skipped breakfast, had lunch at 12:30 PM, dinner at 5:45 PM, and a breakfast equivalent snack at 10:00 PM.
Normal diet then modified diet	Modified diet	Participates in the normal diet will receive 3 meals each day, breakfast at 8:00 AM,lunch at 12:30 PM and dinner at 5:45 PM. Participates in the modified diet skipped breakfast, had lunch at 12:30 PM, dinner at 5:45 PM, and a breakfast equivalent snack at 10:00 PM.
Modified diet then normal diet.	Modified diet	Participates in the modified diet skipped breakfast, had lunch at 12:30 PM, dinner at 5:45 PM, and a breakfast equivalent snack at 10:00 PM.Participates in the normal diet will receive 3 meals each day, breakfast at 8:00 AM,lunch at 12:30 PM and dinner at 5:45 PM.

Primary Outcome Measures

Name	Time	Method
Oxygen intake	56 hours	Subjects were housed in a whole room calorimeter and oxygen consumption was monitored minute by minute
Carbon dioxide exhaled	56 hours	Subjects were housed in a whole room calorimeter and carbon dioxide was monitored minute by minute
Core body temperature	56 hours	The subjects' circadian phase and amplitude will be assessed by continuously recording the core body temperature rhythm with an ingestible Vital Sense monitor.
Locomotor activity	56 hours	The subject's activity will be assessed throughout the experiment using a Actigraph (GT3X) triaxial monitor attached to the subject's wrist, waist, and ankle.

Secondary Outcome Measures

Name	Time	Method
Determination of Body Mass Index (BMI)	Baseline just prior to entry in the metabolic chamber	A dual-energy X-ray absorptiometry (DXA) scan will be performed to assess subject's percentage body fat after check-in and before the first night in the metabolic chamber. Fat content will be used to accurately determine the subject's Body Mass Index.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States