RECRUITING

Western Diet on Cardiometabolic and Immune Function

Conditions

Aging Diet, Healthy added sugars western diet cardiometabolic health T-cell function intestinal permeability

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effects of a 10-day Western Diet on Cardiometabolic and Immune Function in Midlife Adults

Quick Facts

Study Start:2024-07-17

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06528977

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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) * 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)	* 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 * 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.

Inclusion Criteria

Exclusion Criteria

* 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)
* 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)

* 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
* 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.

Contacts and Locations

Study Contact

Kevin Decker, Ph.D.

CONTACT

(302) 831-8137

Deckerkp@udel.edu

Principal Investigator

Christopher Martens, Ph.D.

PRINCIPAL_INVESTIGATOR

University of Delaware

Study Locations (Sites)

University of Delaware

Newark, Delaware, 19713

United States

Collaborators and Investigators

Sponsor: University of Delaware

Christopher Martens, Ph.D., PRINCIPAL_INVESTIGATOR, University of Delaware

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-17

Study Completion Date2027-07

Study Record Updates

Study Start Date2024-07-17

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

added sugars
western diet
cardiometabolic health
T-cell function
intestinal permeability

Additional Relevant MeSH Terms

Aging
Diet, Healthy