What this study is
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.
What's being tested
- High-Fat Diet
Intervention · OTHER
- Low-Fat Diet
Intervention · OTHER
Both interventions
The diet will consist of a breakfast, lunch, dinner, and snack
Study details
- Official title
- Uncovering the Impact of Diet on the Human Circadian Timing System
- Sponsor
- Oregon Health and Science University
- Conditions
- Diet, High-Fat · Circadian Rhythm
- Enrolling
- 14 people
- Starts
- 2022-04-01
- Est. completion
- 2027-03-31
- Design
- Open-label, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 40 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Healthy, lean men and women
You can't join if
- 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:; HDL cholesterol of less than 40 mg/dL in men or less than 50 mg/dL in women;; systolic blood pressure>135 mmHg or diastolic blood pressure>85 mmHg;; Fasting blood glucose ≥ 100 mg/dL;; 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openOregon Health & Science University
Portland, Oregon, United States
- Andrew W McHill, PhD · Contact5034942594mchill@ohsu.edu
Recruiting
Study team
Sponsor
Oregon Health and Science University
Study ID STUDY00022478
Principal investigator
Andrew McHill, PhD
Oregon Health and Science University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.