Meal Schedule Effects on Circadian Energy Balance in Adults

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

Study Overview

• Status: Completed
• Conditions: Circadian Rhythms; Metabolism
• Intervention / Treatment: Behavioral: Normal diet; Behavioral: Modified diet

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal diet then 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.	Behavioral: Normal diet; Participants will receive either a 2000 calorie or a 2500 calorie diet at normal meal times; Behavioral: Modified diet; Participants will receive either a 2000 calorie or a 2500 calorie diet with a single meal shift, breakfast is moved to an hour before bedtime.
Experimental: Modified diet then 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.	Behavioral: Normal diet; Participants will receive either a 2000 calorie or a 2500 calorie diet at normal meal times; Behavioral: Modified diet; Participants will receive either a 2000 calorie or a 2500 calorie diet with a single meal shift, breakfast is moved to an hour before bedtime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen intake	Subjects were housed in a whole room calorimeter and oxygen consumption was monitored minute by minute	56 hours
Carbon dioxide exhaled	Subjects were housed in a whole room calorimeter and carbon dioxide was monitored minute by minute	56 hours
Core body temperature	The subjects' circadian phase and amplitude will be assessed by continuously recording the core body temperature rhythm with an ingestible Vital Sense monitor.	56 hours
Locomotor activity	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.	56 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of Body Mass Index (BMI)	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.	Baseline just prior to entry in the metabolic chamber

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Terry L Page, PhD, Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2015
• Primary Completion (Actual): May 26, 2017
• Study Completion (Actual): May 26, 2017

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 140536

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No