Effects of a Daily Time-Restricted Feeding Protocol on Diet Quality

NCT04348019 | Completed

• 1 other identifier: TRF-DQ
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

As a result of unhealthful lifestyle practices including nighttime ingestion and excess energy-dense food and beverage intake, college students are presenting with metabolic abnormalities and excess weight gain that increases their risk for chronic health conditions including cardiovascular diseases and type 2 diabetes. Research has shown that prolonging nightly fasting intervals can result in health improvements in both animal models and human subjects. Time-restricted feeding (TRF), a form of intermittent fasting may offer an exciting, non-pharmacologic approach to improve cardiometabolic health in this population by restricting food intake to feeding windows that align with circadian biology.

Conditions

Diet, Healthy; Weight Change, Body; Dyslipidemias; Blood Pressure

Keywords

time restricted feeding; fasting; diet quality; body mass index; cardiometabolic biomarkers

Outcome Measures

Primary Outcomes (4)

• Diet quality

  A REAP-S questionnaire will be completed for the previous week's intake during Trial Visits 1-3. The REAP-S questionnaire is a 16-item validated measure of diet quality whereby participants respond to questions that estimate the intake of fruits and vegetables, fiber, sugar, milk, fat, and dietary cholesterol. Responses of 'usually/often' will receive 1 point, 'sometimes' will receive 2 points, and 'rarely/never or does not apply to me' will receive 3 points. Per the REAP-S protocol, responses will be tabulated, and higher scores will indicate better diet quality.

  Change from Baseline at week 8

• Blood pressure

  Both systolic and diastolic blood pressure will be obtained prior to blood draw. Participants will be instructed to sit quietly with their feet planted flat on the floor. After a 10-minute rest period, a non-invasive Omron auto cuff blood pressure monitor equipped with IntelliSense technology, which allows the machine to inflate and deflate at optimum levels depending on arm size, will be utilized to obtain blood pressure in mm Hg.

  Change from Baseline at week 8

• Blood lipids

  . LDL and HDL cholesterol will be measured using a commercially available diagnostic test kit on a bench-top, fully automated, clinical chemistry analyzer (Randox Laboratories Ltd, Crumlin, UK), and results will be expressed in milligrams per deciliter (mg/dL). Triglycerides will be measured using a commercially available diagnostic test kit on a bench-top, fully automated, clinical chemistry analyzer (Randox Laboratories Ltd, Crumlin, UK), and results will be expressed in milligrams per deciliter (mg/dL).

  Change from Baseline at week 8

• Waist circumference

  Waist circumference will be obtained to the nearest 5 cm using a research-grade ergonomic measuring tape placed horizontally around participants' natural waist (i.e., narrowest circumference above the umbilicus). Waist circumference will be measured twice and averaged unless the difference between the first and second measurement is above 5 cm. In that event, a third measurement will be obtained, and the mean of the nearest two circumferences will be recorded.

  Change from Baseline at week 8

Study Arms (2)

Time restricted feeding

EXPERIMENTAL

Participants in the intervention arm of the study will consume food and beverages of their choice within one hour of waking and the feeding window will extend 6 hours. Beyond these hours, participants will observe a prolonged fast (i.e., an 18-h overnight fast).

Behavioral: Fasting

Control

PLACEBO COMPARATOR

Participants in the control arm of the study will fast each night for 8 hours.

Behavioral: Fasting

Interventions

Fasting BEHAVIORAL

Fasting was defined as no foods or caloric beverages.

Control; Time restricted feeding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy (no unresolved medical condition)
• non-smoking (includes vaping)
• normal to under-active (\< 420 minutes of activity/week; not training for or competing in sports events)
• college students (≥18 years old)
• free of acute illnesses or diagnosed chronic diseases (by self-report)
• waist circumference ≥ 80 cm for women, and ≥ 94 cm for men. Participants will not be excluded based on race/ethnicity or socioeconomic status.

You may not qualify if:

• participants who regularly fast for \>12 hours/d or adhere to a fasting regimen (i.e., alternate day fasting, Ramadan-style fasting, 5:2 fasting) at the time of screening or within the past six months
• those with weight loss attempt(s) or weight change (≥ 5 lbs.) within the past six months (including pregnancy)
• those with a history of weight cycling (repeated weight loss and weight gain over time)
• those who currently work night-shifts (i.e., midnight to 6AM), and those unwilling to adhere to the protocol will be excluded from the trial
• pregnant or lactating women, and women not on prescription contraceptives (i.e., birth control pills, IUDs, and patches) (however, if a female applicant states her menstrual cycle is regular, the need to be on prescription contraceptives will be waived)

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Body Weight Changes; Dyslipidemias; Intermittent Fasting; Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Dean

Model Details: 8-week randomized-controlled, 2-arm parallel design trial

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 15, 2020
• Study Start: October 11, 2019
• Primary Completion: April 30, 2020
• Study Completion: December 30, 2020
• Last Updated: December 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)