theFRESHstudy: FRequency of Eating and Its Influence on Satiety and Health

Eating Frequency and Its Influence on Satiety and Biomarkers of Health & Disease

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: High Eating Frequency; Behavioral: Low Eating Frequency

Detailed Description

This proposal will investigate whether eating frequency influences health. Evidence-based recommendations are lacking for the optimal number of daily eating occasions. This is an important area of research because over the past 40 years Americans' eating habits have changed from three meals a day to a pattern whereby most people now have 6-8 daily eating occasions. Apart from potential increases in total energy intake, frequent eating leaves people in a constant postprandial state. This constant, modestly elevated glycemia disturbs the normal glucose-insulin and counter-regulatory hormone network balance and also disturbs downstream cell signaling pathways. A constant postprandial state may increase systemic inflammation and cause numerous other metabolic disturbances. As a result, eating frequency (EF) may be associated with risk of diet-related chronic diseases such as cardiovascular disease, cancer and diabetes, which are the major causes of morbidity, mortality and health care costs in the U.S. To better understand this phenomena the investigators propose a randomized, cross-over clinical trial to test a low-EF eating pattern (three eating occasions/day) vs. a high-EF eating pattern (six eating occasions/day) in relation to inflammation, an adipokine and appetite. The investigators hypothesize that compared to eating three times/day, eating six times/day will increase biomarkers of systemic inflammation, will decrease a beneficial adipokine and will increase both biomarkers and self-reported measures of appetite. The investigators will test their hypothesis with these specific aims: 1) To test the effects of low vs. high eating frequency on inflammatory biomarkers (fasting high-sensitivity C-reactive protein, Interleukin-6 and tumor necrosis factor-α,) and a beneficial adipokine (adiponectin); 2) To test the effects of low vs. high eating frequency on appetite [daily ratings of perceived appetite and serial ratings during a six-hour appetite testing session] and biomarkers involved in appetite regulation and food intake (leptin, ghrelin, peptide YY, and cholecystokinin). The investigators will enroll n=50 males and females who are normal weight, overweight or obese. Participants will complete two 3-week long isocaloric intervention periods in random order [low EF (three eating occasions/day) and high EF (six eating occasions/day)]. Participants will be free-living and eating their own food using study-provided structured meals plans. Study staff will provide on-going support and instruction to maximize adherence to the protocol. Fasting blood samples will be collected at the beginning and end of each study phase. The investigators will test for the intervention effect by using the GEE modification of linear regression to compare mean biomarker response (intervention effect) for each study phase. On the last day of each intervention period, participants will complete 6-hour appetite testing sessions where two test meals will be provided in the low-EF phase and four test meals will be provided in the high-EF phase. Serial appetite ratings and bloods will be collected to assess perceived appetite and hormones of appetite and satiety. Results from this investigation will be used to form guidelines for eating frequency in the context of an overall healthy diet.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High Eating Frequency; 6 Eating Occasions	Behavioral: High Eating Frequency; Free-living participants will complete a 21-day high eating frequency (high EF) Phase in which consume all daily energy at 6 eating occasions.
EXPERIMENTAL: Low Eating Frequency; 3 Eating Occasions	Behavioral: Low Eating Frequency; Free-living participants will complete a 21-day low eating frequency (low EF) Phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test the effects of low vs. high eating frequency on appetite	To test the effects of low vs. high eating frequency on subjective appetite as measured by visual analog scale	3 weeks
Test the effects of low vs. high eating frequency on appetite	To test the effects of low vs. high eating frequency as measured by serial measures of appetite-related biomarkers	6 hours

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ACTUAL): December 19, 2018
• Study Completion (ACTUAL): December 19, 2018

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (ESTIMATE): March 19, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: meal frequency; Satiation; eating frequency; ingestive frequency; Positive energy balance
• Other Study ID Numbers: 8292; 1R01DK103674-01 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO