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

NCT ID: NCT04348019

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-11

Study Completion Date

2020-12-30

Brief Summary

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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.

Detailed Description

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This 8-wk randomized-controlled, parallel arm trial will examine the effects of a daily 18 h fast (TRF protocol) compared to a daily 8-h (CON protocol) on (1) diet quality, (2) cardiometabolic health, and (3) anthropometry in college students enrolled at ASU. Institutional Review Board (IRB) approval will be granted prior to recruitment and commencement of trial activities. Participants will be stratified by age, waist circumference, gender, and METS (activity score) and randomly assigned to one of two study arms: intervention and control. \[Women will begin the trial within 5 days of menses.\] 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). Participants in the control arm of the study will fast each night for 8 hours. During fasting hours, participants will only be permitted to consume non-caloric beverages (preferably water only but unsweetened and non-caloric coffee, tea, etc. will be permitted). Participants will adhere to their daily protocol for 8 weeks. Participants will not receive diet instruction other than 'to fast' and are told to maintain their typical physical activity patterns for the duration of the trial. Participants will choose one 'cheat-day' per week where they are excused from the fasting protocols; this day of the week will be consistent throughout the 8-week trial. Diet quality will be measured by the REAP-S questionnaire, 24-h recalls will be obtained by a registered dietitian via a three-step multiple-pass interview method, a registered nurse or radiology technician will obtain fasting blood draws for biomarkers, and trained research personnel will obtain measures of anthropometry.

Conditions

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Diet, Healthy Weight Change, Body Dyslipidemias Blood Pressure

Keywords

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time restricted feeding fasting diet quality body mass index cardiometabolic biomarkers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

8-week randomized-controlled, 2-arm parallel design trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Time restricted feeding

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).

Group Type EXPERIMENTAL

Fasting

Intervention Type BEHAVIORAL

Fasting was defined as no foods or caloric beverages.

Control

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

Group Type PLACEBO_COMPARATOR

Fasting

Intervention Type BEHAVIORAL

Fasting was defined as no foods or caloric beverages.

Interventions

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Fasting

Fasting was defined as no foods or caloric beverages.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Carol Johnston

Professor and Associate Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Arizona Biomedical Collaborative

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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TRF-DQ

Identifier Type: -

Identifier Source: org_study_id