Lean and Obese: Dietary Inflammation

Completed · Not applicable

Conditions studied: Obesity, Inflammation, Dietary Fat

In brief

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-over design in older adults (men and women) with normal body weight or obesity. Inflammation will be examined by measuring serum endotoxin and other markers, as well as the fecal microbiota.

Key facts

Study ID

NCT05327868

Run by

Rutgers, The State University of New Jersey

People needed

32

Starts

2022-03-01

Expected to finish

2023-02-11

Last updated by the study team

2026-05-13

Who can join

Age: 50 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men or Women
• Age 50-79 years (only postmenopausal women > 2 years)
• Body mass index (20-25 kg/m2; and 30-40 kg/m2)*

You may not qualify if…

• 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

Where it is running

• Rutgers University — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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