Lean and Obese: Dietary Inflammation (LODI)

Rutgers The State University of New Jersey

Status

Completed

Conditions

Inflammation

Obesity

Dietary Fat

Treatments

Other: High Fat Diet (HFD)

Other: Low Fat Diet (LFD)

Study type

Interventional

Funder types

Other

Identifiers

NCT05327868

Pro2019002228

Details and patient eligibility

About

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.

Full 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 individuals who are normal body weight (BMI 19.5-24.9) or who have obesity (BMI of 30 - 40 kg/m2). To characterize persons at baseline, this study will examine body composition, and serum glucose, endotoxin, inflammation and intestinal permeability during fasting and in response to a mixed meal. Also, while it is known that long term intake of foods affects the microbiota, it is unclear whether short-term consumption of a HFD will shift towards a pro-inflammatory gut microbiota compared to a low fat intake. This will be tested in a cross-over design (5 days on a HFD, washout, and 5 days on a LFD) with order randomly assigned in older adults (50+ years of age) who have obesity or are normal weight, and will also be examined by estimated visceral adipose tissue level.

Enrollment

32 patients

Sex

All

Ages

50 to 79 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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