| NCT ID | NCT04743271 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Diet, High-Fat |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 14 participants in total. It began in 2022-04-01 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Healthy, lean men and women Exclusion Criteria: * 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
Contact & Investigator
Andrew McHill, PhD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT04743271 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Diet, High-Fat. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04743271 currently recruiting?
Yes, NCT04743271 is actively recruiting participants. Contact the research team at mchill@ohsu.edu for enrollment information.
Where is the NCT04743271 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT04743271 clinical trial?
NCT04743271 is sponsored by Oregon Health and Science University. The principal investigator is Andrew McHill, PhD at Oregon Health and Science University. The trial plans to enroll 14 participants.