NCT04144426

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

1.6 years

First QC Date

October 22, 2019

Last Update Submit

October 28, 2019

Conditions

MetabolismCircadian Rhythms

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Determination of Body Mass Index (BMI)

    Baseline just prior to entry in the metabolic chamber

Study Arms (2)

Normal diet then modified diet

EXPERIMENTAL

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 dietBehavioral: Modified diet

Modified diet then normal diet.

EXPERIMENTAL

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 dietBehavioral: Modified diet

Interventions

Normal dietBEHAVIORAL

Participants will receive either a 2000 calorie or a 2500 calorie diet at normal meal times

Modified diet then normal diet.Normal diet then modified diet
Modified dietBEHAVIORAL

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.

Modified diet then normal diet.Normal diet then modified diet

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Study Officials

  • Terry L Page, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emeritus of Biological Sciences

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 30, 2019

Study Start

October 8, 2015

Primary Completion

May 26, 2017

Study Completion

May 26, 2017

Last Updated

October 30, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)