RECRUITING

Food and Circadian Timing

Conditions

Diet, High-Fat Circadian Rhythm High Fat Diet

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goals of this study are to uncover the influence of diet on the human circadian timing system. The protocol is a 46-day (28 outpatient days, 18 inpatient days over two 9 day visits) randomized cross-over study designed to elucidate the speed of entrainment in response to a high-fat diet.

Official Title

Uncovering the Impact of Diet on the Human Circadian Timing System

Quick Facts

Study Start:2022-04-01

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04743271

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Healthy, lean men and women	* Major dietary restrictions (such as entirely dairy-free and/or meat-free diets) * A body mass index (BMI) of 18.5\< \[BMI\] \< 24.9 kg/m\^2 and a waist circumference \<94/80cm * Currently psychiatrically/psychologically unsuitable for participation * Drug/alcohol use, including smoking * Medication/drug use, including prescribed and over-the-counter medications * History of working irregular day and night hours, regular night work, or rotating shift work for the 1 year prior to the study. * Traveled across more than 1 time zone during the 3 months prior to the study * Currently consuming a habitual high-fat diet * Chronobiologic and sleep disorders * Diseases of the Cardiovascular System * Metabolic Syndrome; Two or more of these factors will be excluded from the study: 1. HDL cholesterol of less than 40 mg/dL in men or less than 50 mg/dL in women; 2. systolic blood pressure\>135 mmHg or diastolic blood pressure\>85 mmHg; 3. Fasting blood glucose ≥ 100 mg/dL; 4. Triglycerides ≥ 150 mg/dL. * Pre-Diabetes/Diabetes * Hypertension * Disorders of the Respiratory System * Disorders of the Kidney and Urinary Tract * Infectious Diseases * Disorders of the Gastrointestinal System * Disorders of the Immune System * Disorders of the Hematopoietic System * Neoplastic Diseases * Endocrine and Metabolic Diseases * Neurologic Disorders * Subjects must not be currently participating in another research study that would influence their safe participation in our study

Inclusion Criteria

Exclusion Criteria

* Healthy, lean men and women

* Major dietary restrictions (such as entirely dairy-free and/or meat-free diets)
* A body mass index (BMI) of 18.5\< \[BMI\] \< 24.9 kg/m\^2 and a waist circumference \<94/80cm
* Currently psychiatrically/psychologically unsuitable for participation
* Drug/alcohol use, including smoking
* Medication/drug use, including prescribed and over-the-counter medications
* History of working irregular day and night hours, regular night work, or rotating shift work for the 1 year prior to the study.
* Traveled across more than 1 time zone during the 3 months prior to the study
* Currently consuming a habitual high-fat diet
* Chronobiologic and sleep disorders
* Diseases of the Cardiovascular System
* Metabolic Syndrome; Two or more of these factors will be excluded from the study:
1. HDL cholesterol of less than 40 mg/dL in men or less than 50 mg/dL in women;
2. systolic blood pressure\>135 mmHg or diastolic blood pressure\>85 mmHg;
3. Fasting blood glucose ≥ 100 mg/dL;
4. Triglycerides ≥ 150 mg/dL.
* Pre-Diabetes/Diabetes
* Hypertension
* Disorders of the Respiratory System
* Disorders of the Kidney and Urinary Tract
* Infectious Diseases
* Disorders of the Gastrointestinal System
* Disorders of the Immune System
* Disorders of the Hematopoietic System
* Neoplastic Diseases
* Endocrine and Metabolic Diseases
* Neurologic Disorders
* Subjects must not be currently participating in another research study that would influence their safe participation in our study

Contacts and Locations

Study Contact

Andrew McHill, PhD

CONTACT

503-494-2594

mchill@ohsu.edu

Principal Investigator

Andrew McHill, PhD

PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Study Locations (Sites)

Oregon Health & Science University

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

Andrew McHill, PhD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-01

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2022-04-01

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

Circadian Rhythm
High Fat
Diet

Additional Relevant MeSH Terms

Diet, High-Fat
Circadian Rhythm