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Completed

NCT Number: NCT02548026

Meals and Grazing 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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High Eating Frequency (High EF)

Behavioral

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)

Behavioral

Free-living participants complete a 21-day low eating frequency (low EF) Phase in which they consume all daily energy at 3 eating occasions.

Primary outcomes

  1. Inflammatory biomarkers in high vs. low eating frequency conditions

    Time frame: 3 weeks

    Inflammatory biomarkers in high vs. low eating frequency conditions

Secondary outcomes

  1. Subjective appetite in high vs. low eating frequency conditions

    Time frame: 4 hours

    Subjective appetite as reported using visual analog scale in high vs. low eating frequency conditions

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Registry information

Acronym: MAGS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 14, 2015
Registry last updated
Sep 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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