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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04275843
Other study ID # Pro00103827
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date December 21, 2021

Study information

Verified date January 2022
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 grains etc. When considering the role of saturated fat, it may be prudent to advise limiting all foods that contain saturated fats, including unprocessed/minimally processed meat, eggs, whole dairy in addition to processed, pre-packaged foods; however, this reductionist approach fails to take into account the food matrix and overall diet in which these nutrients are consumed. Epidemiological evidence suggests that increased modern, pre-packaged food consumption is a major risk factor for metabolic disease by promoting inflammation. Based on these data, the investigators hypothesize that the pro-atherogenic effect of the Western diet is caused by the pro-inflammatory effects of consuming large amounts of modern ultra-processed foods, and that consumption of a similar amount of fat from minimally processed beef, poultry, dairy, eggs, as part of an unprocessed diet will positively impact inflammatory markers and lipoprotein profiles of study participants when compared to a diet rich in modern ultra-processed foods.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date December 21, 2021
Est. primary completion date December 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 60 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Traditional Diet
Consuming an traditional whole foods based diet for 4 weeks.
Modern Diet
Consuming an processed formulation of the traditional diet for 4 weeks.

Locations

Country Name City State
United States Duke University School of Medicine Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Duke University North Dakota Beef Commission

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in plasma interleukin-6 levels Plasma interleukin-6 levels will be measured before and after each diet Baseline, up to 4 weeks.
Primary Change in plasma c-reactive protein levels Plasma c-reactive protein levels levels will be measured before and after each diet Baseline, up to 4 weeks.
Primary Change in plasma acylcarnitine profiles Plasma acylcarnitines profiles levels will be measured before and after each diet Baseline, up to 4 weeks.
Secondary Change in gut microbiota communities Bifidobacterium, Faecalibacterium prausnitzii, Anerostipes, Roseburia Baseline, up to 4 weeks.
Secondary Energy expenditure Measured by the doubly labeled water method during the last week of each diet up to 4 weeks.
Secondary Change in Neuroinflammation Neurofilament light (NfL), glial fibrillary acidic protein (GFAP), Aß42 and p-tau will be measured before and after each diet Baseline, up to 4 weeks.
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