NCT02392897

Brief Summary

Eating frequency may play an independent role in appetite regulation, overall caloric consumption and measures of long-term health or disease risk. Some literature recommends frequent eating, but pilot data suggest that this type of eating pattern may be harmful to health since it leaves the body in a perpetual fed state and increases systemic inflammation. Therefore, the investigators will conduct a clinical trial in 50 healthy adults to compare a low frequency eating pattern to a high frequency eating pattern in relation to blood-based markers of inflammation, metabolic health and appetite. Study results will be applied to recommendations for eating frequency in the context of an overall healthy diet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2015

Longer than P75 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

First Submitted

Initial submission to the registry

March 4, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2018

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

3.7 years

First QC Date

March 4, 2015

Last Update Submit

July 23, 2019

Conditions

Healthy

Keywords

meal frequencyeating frequencyingestive frequencyPositive energy balanceSatiation

Outcome Measures

Primary Outcomes (1)

  • Test the effects of low vs. high eating frequency on inflammatory biomarkers

    To test the effects of low vs. high eating frequency on inflammatory biomarkers.

    3 weeks

Secondary Outcomes (2)

  • Test the effects of low vs. high eating frequency on appetite

    3 weeks

  • Test the effects of low vs. high eating frequency on appetite

    6 hours

Study Arms (2)

High Eating Frequency

EXPERIMENTAL

6 Eating Occasions

Behavioral: High Eating Frequency

Low Eating Frequency

EXPERIMENTAL

3 Eating Occasions

Behavioral: Low Eating Frequency

Interventions

High Eating FrequencyBEHAVIORAL

Free-living participants will complete a 21-day high eating frequency (high EF) Phase in which consume all daily energy at 6 eating occasions.

High Eating Frequency
Low Eating FrequencyBEHAVIORAL

Free-living participants will complete a 21-day low eating frequency (low EF) Phase

Low Eating Frequency

Eligibility Criteria

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

You may qualify if:

  • Normal, overweight and obese males and females
  • BMI = 18.5-24.9 and 28.0-40.0 kg/m²
  • Ages 18-50 years
  • Live in Seattle, WA

You may not qualify if:

  • Pregnant women
  • Presence of diseases requiring dietary modification, including physician diagnosed cardiovascular disease or diabetes mellitus, use of medications that may impact study results including non-steroidal anti-inflammatory drugs (NSAIDS)
  • Abnormal fasting glucose (\>100 mg/dL)
  • History of disordered or restrained eating and severe food restrictions
  • Individuals with BMI ≥ 40 kg/m2

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)

  • Zhang X, Schenk JM, Perrigue M, Drewnowski A, Wang CY, Beatty SJ, Neuhouser ML. No Effect of High Eating Frequency Compared with Low Eating Frequency on Appetite and Inflammation Biomarkers: Results from a Randomized Crossover Clinical Trial. J Nutr. 2024 Aug;154(8):2422-2430. doi: 10.1016/j.tjnut.2024.04.029. Epub 2024 May 3.

    PMID: 38703890DERIVED

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

March 4, 2015

First Posted

March 19, 2015

Study Start

April 1, 2015

Primary Completion

December 19, 2018

Study Completion

December 19, 2018

Last Updated

July 25, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)