AgingWDNCT06528977
Western Diet on Cardiometabolic and Immune Function
A study testing Western Diet in people with Aging and Diet, Healthy, run by University of Delaware at 1 site in United States.
Trial summary
This study will implement a Western Diet (WD) to understand cardiometabolic and immune function in middle-aged adults (50- 64 years old). Vascular health, intestinal permeability, and T-cell function will be examined before, during, and after the WD. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Diet, Healthy
- What is being tested?
- Western Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ability to provide informed consent
- men and postmenopausal women aged 50-64 years
- systolic blood pressure < 130 mmHg; diastolic blood pressure < 90 mmHg
- body mass index (BMI) <30 kg/m2 and % body fat < 25% for men and < 33% for women
- fasting triglycerides < 200 mg/dl (< 2.3 mmol/L)
- low density lipoprotein (LDL) cholesterol <160 mg/dl (4.14 mmol/L)
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- fasting plasma glucose <126 mg/dl (<7.0 mmol/L)
- weight stable in the prior 6 months (≤ 2 kg weight change)
- blood chemistries indicative of normal liver enzymes and renal function (estimated glomerular filtration rate using the Modification of Diet in Renal Disease (MDRD) prediction equation must be >60 ml/min/1.73 m^2)
Who cannot join
- current use of medications or supplements known to lower blood triglycerides or cholesterol (e.g., fibrates, statins, high dose niacin, high dose omega-3 supplement)
- chronic clinical diseases (e.g., coronary artery/peripheral artery/cerebrovascular diseases, heart failure, diabetes, chronic kidney disease requiring dialysis, neurological or autoimmune conditions affecting cognition (e.g. Alzheimer's disease or other forms of dementia, Parkinson's disease, epilepsy, multiple sclerosis, large vessel infarct)
- major psychiatric disorder (e.g. schizophrenia, bipolar disorder)
- current or past (i.e., last 3 months) use of anti-hypertensive or other cardiovascular-acting medications known to influence vascular function and/or arterial stiffness
- current medication use likely to affect central nervous system (CNS) functions (e.g. long active benzodiazepines)
- concussion within last 2 years and ≥ 3 lifetime concussions
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- heavy alcohol consumption (≥8 drinks/week for women and ≥15 drinks/week for men)
- recent major change in health status within the previous 6 months (i.e., surgery, significant infection, or illness)
- current smoking within the past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Delaware
Newark, Delaware, 19713
Christopher Martens, Ph.D.
About this study
Official title: Effects of a 10-day Western Diet on Cardiometabolic and Immune Function in Midlife Adults
This study will implement a Western Diet (WD) to understand cardiometabolic and immune function in middle-aged adults (50- 64 years old). Vascular health, intestinal permeability, and T-cell function will be examined before, during, and after the WD. The WD is a 10-day diet and will consist of 25% of total energy from added sugars.
Read the detailed description
Aging is the primary risk factor for Alzheimer's disease (AD) which is the most common form of dementia and among the fastest-growing causes of morbidity and mortality in the United States. The risk factors for AD emerge during midlife and are similar to cardiovascular diseases, one of which has particular interest is high blood pressure. The impact of blood vessels and high blood pressure are made worse by poor lifestyle habits, including eating a Western Diet (WD) that contains processed food and high amounts of added sugars (e.g., foods containing high amounts of fructose), with little to no fiber intake from fruits and vegetables. Previous data indicates a 10-day WD can acutely increase triglycerides and blood pressure. These cardiometabolic changes are thought to involve the immune system, however, it is not exactly known how a WD triggers an inflammatory response. This project aims to determine the role of diet-induced changes in gut health and the function of the immune system (T-cells) in midlife adults. It is hypothesized that eating a WD will acutely make the small intestine more permeable, concurrent with activation of the immune system measured via T-cell function. To test this hypothesis, gut health, T-cell function, and blood vessel function will be measured before, during, and after a 10-day WD. The data generated from this project will help bridge the gap in understanding the relation between diet and the immune system. The results will support future grant proposals to the National Institutes of Health aimed at using dietary interventions to protect against high blood pressure and cognitive impairment in mid-life adults.
- Conditions
- Aging, Diet, Healthy
- Being tested
- Western Diet
- Keywords
- added sugars, western diet, cardiometabolic health, T-cell function, intestinal permeability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Western DietOther
Consumption of 10 days of a diet high in added sugars (25% of total caloric intake)
| Study group | Role | What they receive |
|---|---|---|
| Western Diet | Experimental | Consumption of 10 days of a diet high in added sugars (25% of total caloric intake) Receives: Other: Western Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Arterial Blood Pressure (mmHg)
Comparison between before, during and after western diet
Measured: Over the course of 1-2 months
Change in relative brachial artery flow-mediated dilation (%)
Comparison between before, during and after western diet
Measured: Over the course of 1-2 months
Change in absolute brachial artery flow-mediated dilation (mm)
Comparison between before, during and after western diet
Measured: Over the course of 1-2 months
Change in T-cell mitochondria respiration (oxygen consumption rate)
Comparison between before, during and after western diet
Measured: Over the course of 1-2 months
Change in T-cell flow cytometry (%)
Comparison between before, during and after western diet
Measured: Over the course of 1-2 months
Change in intestinal permeability (lactulose : mannitol test)
Comparison between before, during and after western diet
Measured: Over the course of 1-2 months
Change in triglycerides (mg/dL)
Comparison between before, during and after western diet
Measured: Over the course of 1-2 months
Change in cholesterol (mg/dL)
Comparison between before, during and after western diet
Measured: Over the course of 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start17 Jul 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A controlled feeding study prepared by registered dieticians. Participants will be pre-tested, provided a 10-day WD to be tested on day 10, then post-tested.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Christopher Martens, Ph.D., Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528977
- Sponsor's protocol ID
- 2199946
- Other IDs
- P20GM113125
- Acronym
- WD
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 10-day Western Diet on Cardiometabolic and Immune Function in Midlife Adults
- ClinicalTrials.gov ID
- NCT06528977
- Acronym / sponsor ID
- WD / 2199946
- Conditions
- Aging, Diet, Healthy
- Keywords
- added sugars, western diet, cardiometabolic health, T-cell function, intestinal permeability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Jul 2024 (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.
This study will implement a Western Diet (WD) to understand cardiometabolic and immune function in middle-aged adults (50- 64 years old). Vascular health, intestinal permeability, and T-cell function will be examined before, during, and after the WD. The WD is a 10-day diet and will consist of 25% of total energy from added sugars.
Detailed description
Aging is the primary risk factor for Alzheimer's disease (AD) which is the most common form of dementia and among the fastest-growing causes of morbidity and mortality in the United States. The risk factors for AD emerge during midlife and are similar to cardiovascular diseases, one of which has particular interest is high blood pressure. The impact of blood vessels and high blood pressure are made worse by poor lifestyle habits, including eating a Western Diet (WD) that contains processed food and high amounts of added sugars (e.g., foods containing high amounts of fructose), with little to no fiber intake from fruits and vegetables. Previous data indicates a 10-day WD can acutely increase triglycerides and blood pressure. These cardiometabolic changes are thought to involve the immune system, however, it is not exactly known how a WD triggers an inflammatory response. This project aims to determine the role of diet-induced changes in gut health and the function of the immune system (T-cells) in midlife adults. It is hypothesized that eating a WD will acutely make the small intestine more permeable, concurrent with activation of the immune system measured via T-cell function. To test this hypothesis, gut health, T-cell function, and blood vessel function will be measured before, during, and after a 10-day WD. The data generated from this project will help bridge the gap in understanding the relation between diet and the immune system. The results will support future grant proposals to the National Institutes of Health aimed at using dietary interventions to protect against high blood pressure and cognitive impairment in mid-life adults.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A controlled feeding study prepared by registered dieticians. Participants will be pre-tested, provided a 10-day WD to be tested on day 10, then post-tested.
| Arm | Type | Receives |
|---|---|---|
| Western Diet | Experimental | Other: Western DietConsumption of 10 days of a diet high in added sugars (25% of total caloric intake) |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- ability to provide informed consent
- men and postmenopausal women aged 50-64 years
- systolic blood pressure < 130 mmHg; diastolic blood pressure < 90 mmHg
- body mass index (BMI) <30 kg/m2 and % body fat < 25% for men and < 33% for women
- fasting triglycerides < 200 mg/dl (< 2.3 mmol/L)
Key exclusion criteria (9 listed)
- current use of medications or supplements known to lower blood triglycerides or cholesterol (e.g., fibrates, statins, high dose niacin, high dose omega-3 supplement)
- chronic clinical diseases (e.g., coronary artery/peripheral artery/cerebrovascular diseases, heart failure, diabetes, chronic kidney disease requiring dialysis, neurological or autoimmune conditions affecting cognition (e.g. Alzheimer's disease or other forms of dementia, Parkinson's disease, epilepsy, multiple sclerosis, large vessel infarct)
- major psychiatric disorder (e.g. schizophrenia, bipolar disorder)
- current or past (i.e., last 3 months) use of anti-hypertensive or other cardiovascular-acting medications known to influence vascular function and/or arterial stiffness
- current medication use likely to affect central nervous system (CNS) functions (e.g. long active benzodiazepines)
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 |
|---|---|---|
| Western DietConsumption of 10 days of a diet high in added sugars (25% of total caloric intake) | Other | Western Diet |
Primary outcome
Change in Mean Arterial Blood Pressure (mmHg)
Time frame: Over the course of 1-2 months
Comparison between before, during and after western diet
Change in relative brachial artery flow-mediated dilation (%)
Time frame: Over the course of 1-2 months
Comparison between before, during and after western diet
Change in absolute brachial artery flow-mediated dilation (mm)
Time frame: Over the course of 1-2 months
Comparison between before, during and after western diet
Change in T-cell mitochondria respiration (oxygen consumption rate)
Time frame: Over the course of 1-2 months
Comparison between before, during and after western diet
Change in T-cell flow cytometry (%)
Time frame: Over the course of 1-2 months
Comparison between before, during and after western diet
Change in intestinal permeability (lactulose : mannitol test)
Time frame: Over the course of 1-2 months
Comparison between before, during and after western diet
Change in triglycerides (mg/dL)
Time frame: Over the course of 1-2 months
Comparison between before, during and after western diet
Change in cholesterol (mg/dL)
Time frame: Over the course of 1-2 months
Comparison between before, during and after western diet
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Christopher Martens, Ph.D. principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Western Diet in people with Aging and Diet, Healthy, run by University of Delaware 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Decker, Ph.D. ((302) 831-8137, Deckerkp@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Arterial Blood Pressure (mmHg) (time frame: Over the course of 1-2 months). The study lists 8 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 30 Jul 2024.