NCT02548026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

1.4 years

First QC Date

September 8, 2015

Last Update Submit

September 10, 2015

Conditions

Keywords

meal frequencyeating frequencyingestive frequencypositive energy balancesatietyappetitehunger

Outcome Measures

Primary Outcomes (1)

  • Inflammatory biomarkers in high vs. low eating frequency conditions

    Inflammatory biomarkers in high vs. low eating frequency conditions

    3 weeks

Secondary Outcomes (1)

  • Subjective appetite in high vs. low eating frequency conditions

    4 hours

Study Arms (2)

High Eating Frequency (High EF)

EXPERIMENTAL

8 Eating Occasions

Behavioral: High Eating Frequency (High EF)

Low Eating Frequency (High EF)

EXPERIMENTAL

3 Eating Occasions

Behavioral: Low Eating Frequency (Low EF)

Interventions

Free-living participants complete a 21-day high eating frequency (high EF) Phase in which they consume all daily energy at 8 eating occasions.

High Eating Frequency (High 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.

Low Eating Frequency (High EF)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Marian Neuhouser, PhD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2015

First Posted

September 14, 2015

Study Start

January 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 14, 2015

Record last verified: 2015-09

Locations