Status:
COMPLETED
Lean and Obese: Dietary Inflammation
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Obesity
Inflammation
Eligibility:
All Genders
50-79 years
Phase:
NA
Brief Summary
In the Lean and Obese Dietary Inflammation (LODI) study, the primary goal is to determine the effect of short-term intake of high dietary fat (5 days) compared to low fat intake (5 days) in a cross-ov...
Detailed Description
In the Lean and Obese Dietary Inflammation (LODI) study, short-term intake of a high-fat diet (HFD) that is also high in saturated fatty acids will be examined compared to a low-fat diet (LFD) in indi...
Eligibility Criteria
Inclusion
- Men or Women
- Age 50-79 years (only postmenopausal women \> 2 years)
- Body mass index (20-25 kg/m2; and 30-40 kg/m2)\*
Exclusion
- Diagnosed with, active, or history of liver cirrhosis, chronic or persisting hepatitis
- Diagnosed with, active, or history of cancer
- History of gastrointestinal disease or surgical procedure for weight loss.
- Diagnosed with immune diseases, type 2 diabetes, pancreatitis, or infectious diseases
- Any surgery in the past 6 months
- Currently using or have used antibiotics continuously \> 3 days in the past 3 months
- Regular use of medications for that affect the gastrointestinal tract, cholecystitis, urinary tract infection, severe organic diseases including coronary heart disease, myocardial infarction, infectious diseases including pulmonary tuberculosis and AIDS
- Known allergy or intolerance to any ingredients in the dietary intervention program
- Alcohol or illicit drug abuse
- Current Smoker or have quit smoking in the past 3 months
- Recent colonoscopy (within the previous two months)
- Inability to follow any of the experimental diets (including low or high fat diet) or to perform the collections required for this study
- Participants will also be excluded if they have extreme dietary habits, extreme levels of physical or athletic activity, or by changes in body weight \>5 lbs. during the last 6 months
- Uncontrolled hypertension or uncontrolled hyperlipidemia in abnormal ranges.
- Participation in another clinical research trial that may interfere with the results of this study.
- As needed, BMI (kg/m2) will be adjusted accordingly for Asian lean and obese definitions
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05327868
Start Date
March 1 2022
End Date
February 11 2023
Last Update
March 25 2024
Active Locations (1)
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1
Rutgers University
New Brunswick, New Jersey, United States, 08901