MetabolismNCT04144426
Meal Schedule Effects on Circadian Energy Balance in Adults
A study testing Normal diet and Modified diet in people with Metabolism and Circadian Rhythms, run by Vanderbilt University at 1 site in United States.
Trial summary
This study will test will how eating on a particular daily schedule may effect energy, weight gain or loss, and body temperature. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolism, Circadian Rhythms
- What is being tested?
- Normal diet and Modified diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2015to 26 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
This study will test will how eating on a particular daily schedule may effect energy, weight gain or loss, and body temperature.
Read the 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
- Metabolism, Circadian Rhythms
- Being tested
- Normal diet, Modified diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal dietBehavioural
Participants will receive either a 2000 calorie or a 2500 calorie diet at normal meal times
Modified dietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Normal diet; Behavioral: 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. Receives: Behavioral: Normal diet; Behavioral: Modified diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen intake
Subjects were housed in a whole room calorimeter and oxygen consumption was monitored minute by minute
Measured: 56 hours
Carbon dioxide exhaled
Subjects were housed in a whole room calorimeter and carbon dioxide was monitored minute by minute
Measured: 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.
Measured: 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.
Measured: 56 hours
Secondary outcomes (1)
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.
Measured: Baseline just prior to entry in the metabolic chamber
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start8 Oct 2015
- Primary completion26 May 2017
- Study completion26 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terry Page, Vanderbilt University
- Investigators
- Terry L Page, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144426
- Sponsor's protocol ID
- 140536
- Status last verified
- Oct 2019
- First submitted
- 22 Oct 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meal Schedule Effects on Circadian Energy Balance in Adults
- ClinicalTrials.gov ID
- NCT04144426
- Acronym / sponsor ID
- 140536
- Conditions
- Metabolism, Circadian Rhythms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 8 Oct 2015 (actual)
- Primary completion
- 26 May 2017 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal diet then modified diet | Experimental | Behavioral: Normal diet, Behavioral: Modified dietParticipates 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. | Experimental | Behavioral: Normal diet, Behavioral: Modified dietParticipates 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal dietParticipants will receive either a 2000 calorie or a 2500 calorie diet at normal meal times | Behavioural | Modified diet then normal diet., Normal diet then modified diet |
| Modified 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. | Behavioural | Modified diet then normal diet., Normal diet then modified diet |
Primary outcome
Oxygen intake
Time frame: 56 hours
Subjects were housed in a whole room calorimeter and oxygen consumption was monitored minute by minute
Carbon dioxide exhaled
Time frame: 56 hours
Subjects were housed in a whole room calorimeter and carbon dioxide was monitored minute by minute
Core body temperature
Time frame: 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
Time frame: 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.
1 secondary outcome
Determination of Body Mass Index (BMI)
Time frame: Baseline just prior to entry in the metabolic chamber
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry L Page, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal diet and Modified diet in people with Metabolism and Circadian Rhythms, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen intake (time frame: 56 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.