Status:
COMPLETED
The Effects of Western Diet Patterns on Plasma Inflammatory and Cardio Metabolic Health Signatures in Middle-aged Adults
Lead Sponsor:
Duke University
Collaborating Sponsors:
North Dakota Beef Commission
Conditions:
Healthy Diet
Eligibility:
All Genders
35-60 years
Phase:
NA
Brief Summary
The Western diet pattern or standard American diet is a modern dietary pattern that is characterized by high intakes of meat, pre-packaged foods, fried foods, high-fat dairy products, eggs, refined gr...
Eligibility Criteria
Inclusion
- Age ≥35 and ≤60 years;
- BMI ≥25 and ≤35 kg/m2;
- Weight stable in last 3 months (Loss or gain \<4%);
- Consistent physical activity levels;
- Hemoglobin A1C (HbA1C) ≤6.4%;
- Fasting insulin; \<15 µU/mL;
- Fasting plasma glucose concentration \<126 mg/dl;
- Willingness to eat the food provided in this study;
- Subjects must be able to speak and understand English to participate in this study
- Own a smartphone or other mobile device capable of downloading the Garmin Connect app.
Exclusion
- Diagnoses of active malignancy, congestive heart failure, diabetes mellitus, chronic obstructive pulmonary disease, thyroid disease or other metabolic disorders that influence metabolism;
- Evidence of impaired kidney function (Estimated glomerular filtration rate \[eGFR\] \<44 mL/min;
- Regular use of medication that interferes with the measurement of study outcomes as determined by the study team (e.g., NSAIDs, corticosteroids);
- Consuming \>14 drinks per week of \>4 drinks per night twice/week for male; \>7 drinks per week or \>3 drinks per night twice/week for female;
- Use of cigarettes (or other tobacco products) or use of any other (recreational) drug in last 3 months;
- Engaged in high-level competitive exercise (e.g., marathons, triathlons, cycling, weight-lifting competitions etc.)
- Self-reported sleep duration \<5 hours per night;
- Any inflammatory diseases (e.g. asthma, autoimmune diseases, coeliac disease, glomerulonephritis, hepatitis, inflammatory bowel disease, arthritis);
- Use of antibiotics in last 30 days;
- Pregnant or lactating women;
- Eating disorders (e.g., anorexia nervosa, bulimia nervosa, binge eating disorders etc.)
- Psychological disorders (e.g., clinical depression, bipolar disorders etc.);
- Strict dietary patterns (e.g., vegan, carnivore, kosher, low-carb etc.);
- History of stomach or bowel resection (other than appendectomy), gastric bypass or other bariatric weight loss procedure effecting absorption;
- Persons who are not able to grant voluntary informed consent;
- Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04275843
Start Date
October 1 2020
End Date
December 21 2021
Last Update
July 13 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University School of Medicine
Durham, North Carolina, United States, 27701