HealthyMAGSNCT02548026
Meals and Grazing Study
A study testing High Eating Frequency (High EF) and Low Eating Frequency (Low EF) in people with Healthy, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
The purpose of this study was to determine the effects of low vs. high eating frequency (EF) on biomarkers of health and subjective appetite. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High Eating Frequency (High EF) and Low Eating Frequency (Low EF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jun 2012
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be overweight and obese (BMI 25 and over) males and females ages 18-50 years.
- Participants must be willing to report to FHCRC on 5 occasions (initial screening appointment + 4 testing sessions)
- Participants must be willing to provide a 7-day food record for analysis prior to Phase 1 and Phase 2 of the study
- Participants must be willing to follow diet protocol during Phase 1 of the study
- Participants must be willing to undergo 4 blood draws
Who cannot join
- Non-diabetic (self-report)
- Non-smokers (self-report)
- Not following a diet to gain or lose weight (self-report)
- Normal cholesterol (self-report)
- Normal blood pressure (self-report)
- Not currently taking any medication (self-report)
- Not pregnant or nursing (self-report and verification by DEXA)
- Not athletes in training (self-report)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
The purpose of this study was to determine the effects of low vs. high eating frequency (EF) on biomarkers of health and subjective appetite.
Read the detailed description
Observational studies have demonstrated an inverse relationship between eating frequency (EF), obesity, and other markers for disease risk. It has been suggested that consumption of several small, frequent meals may influence physiological mechanisms, reducing the risk for disease and lowering appetite. Participants in this randomized crossover study completed two intervention phases lasting three weeks each: one of low eating frequency ("low-EF"; 3 eating occasions/day) and one of high eating frequency ("high-EF"; 8 eating occasions/day). Fasting C-reactive protein, insulin-like growth factor, and leptin were measured at baseline and endpoint of each phase and an optional subjective appetite testing session lasting four hours was offered at the endpoint of each phase. During appetite testing sessions, participants consumed an amount of food equal in total energy and macronutrient content at either one occasion at 8:00 am ("low-EF" condition) or spread evenly over two smaller eating occasions at 8:00 am and 10:30 am ("high-EF" condition). Ratings of hunger, desire to eat, fullness, thirst, and nausea were made every 30 minutes using paper-and-pencil semi-anchored 100-mm Visual Analog Scales. A composite appetite score was calculated as the mean of hunger, desire to eat, and 100-fullness. The generalized estimating equation modification of linear regression was used to compare fasting plasma biomarkers and mean ratings of subjective appetite.
- Conditions
- Healthy
- Being tested
- High Eating Frequency (High EF), Low Eating Frequency (Low EF)
- Keywords
- meal frequency, eating frequency, ingestive frequency, positive energy balance, satiety, appetite, hunger
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Eating Frequency (High EF)Behavioural
Free-living participants complete a 21-day high eating frequency (high EF) Phase in which they consume all daily energy at 8 eating occasions.
Low Eating Frequency (Low EF)Behavioural
Free-living participants complete a 21-day low eating frequency (low EF) Phase in which they consume all daily energy at 3 eating occasions.
| Study group | Role | What they receive |
|---|---|---|
| High Eating Frequency (High EF) | Experimental | 8 Eating Occasions Receives: Behavioral: High Eating Frequency (High EF) |
| Low Eating Frequency (High EF) | Experimental | 3 Eating Occasions Receives: Behavioral: Low Eating Frequency (Low EF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory biomarkers in high vs. low eating frequency conditions
Inflammatory biomarkers in high vs. low eating frequency conditions
Measured: 3 weeks
Secondary outcomes (1)
Subjective appetite in high vs. low eating frequency conditions
Subjective appetite as reported using visual analog scale in high vs. low eating frequency conditions
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marian Neuhouser, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548026
- Sponsor's protocol ID
- 7439
- Acronym
- MAGS
- Status last verified
- Sep 2015
- First submitted
- 8 Sep 2015
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Perrigue MM, Drewnowski A, Wang CY, Neuhouser ML. Higher Eating Frequency Does Not Decrease Appetite in Healthy Adults. J Nutr. 2016 Jan;146(1):59-64. doi: 10.3945/jn.115.216978. Epub 2015 Nov 11.
PubMed 26561409
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meals and Grazing Study
- ClinicalTrials.gov ID
- NCT02548026
- Acronym / sponsor ID
- MAGS / 7439
- Conditions
- Healthy
- Keywords
- meal frequency, eating frequency, ingestive frequency, positive energy balance, satiety, appetite, hunger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Sep 2015 (estimated)
- 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.
The purpose of this study was to determine the effects of low vs. high eating frequency (EF) on biomarkers of health and subjective appetite.
Detailed description
Observational studies have demonstrated an inverse relationship between eating frequency (EF), obesity, and other markers for disease risk. It has been suggested that consumption of several small, frequent meals may influence physiological mechanisms, reducing the risk for disease and lowering appetite. Participants in this randomized crossover study completed two intervention phases lasting three weeks each: one of low eating frequency ("low-EF"; 3 eating occasions/day) and one of high eating frequency ("high-EF"; 8 eating occasions/day). Fasting C-reactive protein, insulin-like growth factor, and leptin were measured at baseline and endpoint of each phase and an optional subjective appetite testing session lasting four hours was offered at the endpoint of each phase. During appetite testing sessions, participants consumed an amount of food equal in total energy and macronutrient content at either one occasion at 8:00 am ("low-EF" condition) or spread evenly over two smaller eating occasions at 8:00 am and 10:30 am ("high-EF" condition). Ratings of hunger, desire to eat, fullness, thirst, and nausea were made every 30 minutes using paper-and-pencil semi-anchored 100-mm Visual Analog Scales. A composite appetite score was calculated as the mean of hunger, desire to eat, and 100-fullness. The generalized estimating equation modification of linear regression was used to compare fasting plasma biomarkers and mean ratings of subjective appetite.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Eating Frequency (High EF) | Experimental | Behavioral: High Eating Frequency (High EF)8 Eating Occasions |
| Low Eating Frequency (High EF) | Experimental | Behavioral: Low Eating Frequency (Low EF)3 Eating Occasions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants will be overweight and obese (BMI 25 and over) males and females ages 18-50 years.
- Participants must be willing to report to FHCRC on 5 occasions (initial screening appointment + 4 testing sessions)
- Participants must be willing to provide a 7-day food record for analysis prior to Phase 1 and Phase 2 of the study
- Participants must be willing to follow diet protocol during Phase 1 of the study
- Participants must be willing to undergo 4 blood draws
Key exclusion criteria (8 listed)
- Non-diabetic (self-report)
- Non-smokers (self-report)
- Not following a diet to gain or lose weight (self-report)
- Normal cholesterol (self-report)
- Normal blood pressure (self-report)
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 |
|---|---|---|
| High Eating Frequency (High EF)Free-living participants complete a 21-day high eating frequency (high EF) Phase in which they consume all daily energy at 8 eating occasions. | Behavioural | High Eating Frequency (High EF) |
| Low Eating Frequency (Low EF)Free-living participants complete a 21-day low eating frequency (low EF) Phase in which they consume all daily energy at 3 eating occasions. | Behavioural | Low Eating Frequency (High EF) |
Primary outcome
Inflammatory biomarkers in high vs. low eating frequency conditions
Time frame: 3 weeks
Inflammatory biomarkers in high vs. low eating frequency conditions
1 secondary outcome
Subjective appetite in high vs. low eating frequency conditions
Time frame: 4 hours
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 14 Sep 2015.
- Derived from this study: PubMed 26561409Perrigue MM, Drewnowski A, Wang CY, Neuhouser ML. Higher Eating Frequency Does Not Decrease Appetite in Healthy Adults. J Nutr. 2016 Jan;146(1):59-64. doi: 10.3945/jn.115.216978. Epub 2015 Nov 11.
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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.
Marian Neuhouser, PhD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Eating Frequency (High EF) and Low Eating Frequency (Low EF) in people with Healthy, run by Fred Hutchinson Cancer Center 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 8 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 14 Sep 2015. 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?
Inflammatory biomarkers in high vs. low eating frequency conditions (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02548026, which also lists 1 linked publication.
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 14 Sep 2015.