Meals and Grazing Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Meals and Grazing Study

Conditions
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Healthy

Intervention / Treatment
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* Behavioral: High Eating Frequency (High EF)
* Behavioral: Low Eating Frequency (Low EF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Eating Frequency (High EF)<br>8 Eating Occasions | Behavioral: High Eating Frequency (High EF)<br>* Free-living participants complete a 21-day high eating frequency (high EF) Phase in which they consume all daily energy at 8 eating occasions.<br>|
| Experimental: Low Eating Frequency (High EF)<br>3 Eating Occasions | Behavioral: Low Eating Frequency (Low EF)<br>* Free-living participants complete a 21-day low eating frequency (low EF) Phase in which they consume all daily energy at 3 eating occasions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory biomarkers in high vs. low eating frequency conditions | Inflammatory biomarkers in high vs. low eating frequency conditions | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite in high vs. low eating frequency conditions | Subjective appetite as reported using visual analog scale in high vs. low eating frequency conditions | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meal frequency, eating frequency, ingestive frequency, positive energy balance, satiety, appetite, hunger