Meals and Grazing Study

NCT ID: NCT02548026

Last Updated: 2015-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-06-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

High Eating Frequency (High EF)

8 Eating Occasions

Group Type: EXPERIMENTAL

High Eating Frequency (High EF)

Intervention Type: 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 (High EF)

3 Eating Occasions

Group Type: EXPERIMENTAL

Low Eating Frequency (Low EF)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marian Neuhouser, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26561409 (View on PubMed)

Other Identifiers

7439

Identifier Type: -

Identifier Source: org_study_id