The Effects of Western Diet Patterns on Plasma Inflammatory and Cardio Metabolic Health Signatures in Middle-aged Adults

NCT04275843 | Completed DMC

• 1 other identifier: Pro00103827
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy Diet

Outcome Measures

Primary Outcomes (3)

• Change in plasma interleukin-6 levels

  Plasma interleukin-6 levels will be measured before and after each diet

  Baseline, up to 4 weeks.

• 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.

• Change in plasma acylcarnitine profiles

  Plasma acylcarnitines profiles levels will be measured before and after each diet

  Baseline, up to 4 weeks.

Secondary Outcomes (3)

• Change in gut microbiota communities

  Baseline, up to 4 weeks.

• Energy expenditure

  up to 4 weeks.

• Change in Neuroinflammation

  Baseline, up to 4 weeks.

Study Arms (2)

Traditional Diet

ACTIVE COMPARATOR

Unprocessed/minimally processed whole foods.

Dietary Supplement: Traditional Diet

Modern Diet

ACTIVE COMPARATOR

Multi-ingredient, ultra-processed formulations of the traditional diet.

Dietary Supplement: Modern Diet

Interventions

Traditional Diet DIETARY_SUPPLEMENT

Consuming an traditional whole foods based diet for 4 weeks.

Traditional Diet

Modern Diet DIETARY_SUPPLEMENT

Consuming an processed formulation of the traditional diet for 4 weeks.

Modern Diet

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Duke University: lead
• North Dakota Beef Commission: collaborator

Study Sites (1)

Duke University School of Medicine

Durham, North Carolina, 27701, United States

Location

Study Officials

• Stephan van Vliet, PhD

  Duke University

  STUDY DIRECTOR

• Kim Huffman, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As this is feeding study with two very much different diets, participants and investigators were not blinded. The Core facilities that are analyzing de-identified coded samples and remain blinded to treatments.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 19, 2020
• Study Start: October 1, 2020
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: July 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)