Healthy DietNCT04275843
The Effects of Western Diet Patterns on Plasma Inflammatory and Cardio Metabolic Health Signatures in Middle-aged Adults
A study testing Traditional Diet and Modern Diet in people with Healthy Diet, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet
- What is being tested?
- Traditional Diet and Modern Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 21 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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.)
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Medicine
Durham, North Carolina, 27701
About this study
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
- Being tested
- Traditional Diet, Modern Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional DietDietary supplement
Consuming an traditional whole foods based diet for 4 weeks.
Modern DietDietary supplement
Consuming an processed formulation of the traditional diet for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Diet | Active comparator | Unprocessed/minimally processed whole foods. Receives: Dietary Supplement: Traditional Diet |
| Modern Diet | Active comparator | Multi-ingredient, ultra-processed formulations of the traditional diet. Receives: Dietary Supplement: Modern Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma interleukin-6 levels
Plasma interleukin-6 levels will be measured before and after each diet
Measured: 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
Measured: Baseline, up to 4 weeks.
Change in plasma acylcarnitine profiles
Plasma acylcarnitines profiles levels will be measured before and after each diet
Measured: Baseline, up to 4 weeks.
Secondary outcomes (3)
Change in gut microbiota communities
Bifidobacterium, Faecalibacterium prausnitzii, Anerostipes, Roseburia
Measured: Baseline, up to 4 weeks.
Energy expenditure
Measured by the doubly labeled water method during the last week of each diet
Measured: up to 4 weeks.
Change in Neuroinflammation
Neurofilament light (NfL), glial fibrillary acidic protein (GFAP), Aß42 and p-tau will be measured before and after each diet
Measured: Baseline, up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Oct 2020
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- North Dakota Beef Commission
- Responsible party
- Sponsor
- Investigators
- Stephan van Vliet, PhD, Study director, Duke UniversityKim Huffman, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275843
- Sponsor's protocol ID
- Pro00103827
- Status last verified
- Jan 2022
- First submitted
- 7 Feb 2020
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Western Diet Patterns on Plasma Inflammatory and Cardio Metabolic Health Signatures in Middle-aged Adults
- ClinicalTrials.gov ID
- NCT04275843
- Acronym / sponsor ID
- Pro00103827
- Conditions
- Healthy Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- North Dakota Beef Commission
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Diet | Active comparator | Dietary Supplement: Traditional DietUnprocessed/minimally processed whole foods. |
| Modern Diet | Active comparator | Dietary Supplement: Modern DietMulti-ingredient, ultra-processed formulations of the traditional diet. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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%;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional DietConsuming an traditional whole foods based diet for 4 weeks. | Dietary supplement | Traditional Diet |
| Modern DietConsuming an processed formulation of the traditional diet for 4 weeks. | Dietary supplement | Modern Diet |
Primary outcome
Change in plasma interleukin-6 levels
Time frame: Baseline, up to 4 weeks.
Plasma interleukin-6 levels will be measured before and after each diet
Change in plasma c-reactive protein levels
Time frame: Baseline, up to 4 weeks.
Plasma c-reactive protein levels levels will be measured before and after each diet
Change in plasma acylcarnitine profiles
Time frame: Baseline, up to 4 weeks.
Plasma acylcarnitines profiles levels will be measured before and after each diet
3 secondary outcomes
Change in gut microbiota communities
Time frame: Baseline, up to 4 weeks.
Energy expenditure
Time frame: up to 4 weeks.
Change in Neuroinflammation
Time frame: Baseline, up to 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy Diet
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Not yet recruiting
Effects of Ad Libitum Ultra-Processed Diet on Brain Dopamine in Humans
Healthy Volunteers
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Not yet recruiting
Web-Based Sustainable Food Literacy Program for University Students
Food Literacy, Healthy Eating
Recruiting
Environmental Harm Menu Labels and Overall Dietary Quality
Food Choices
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan van Vliet, PhD study director
Duke University
Kim Huffman, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Diet and Modern Diet in people with Healthy Diet, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma interleukin-6 levels (time frame: Baseline, up to 4 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.