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Completed

NCT Number: NCT05327868

Lean and Obese: Dietary Inflammation

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.

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Key information

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Fat Diet (LFD)

Other

Subjects will be asked to adhere to a low fat diet (assigned in random order) and be counseled by a dietitian using 5 days of sample menus, monitored online using a shared nutrient analysis program, and supplied with low fat foods to increase compliance

Other names: low fat diet

High Fat Diet (HFD)

Other

Subjects will be asked to adhere to a high fat diet that is rich in SFAs (assigned in random order) and be counseled by a dietitian using sample 5 days of menus, monitored online using a shared nutrient analysis program, and supplied with high fat foods to increase compliance

Other names: high fat (high SFA) diet

Primary outcomes

  1. Change in Endotoxin from Low to High fat diet

    Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks

    serum and stool

  2. Change in Microbiome composition

    Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks

    stool

Secondary outcomes

  1. Inflammatory markers

    Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks

    Serum IL-6, hsCRP, TNF-alpha, TLR4 (grams/volume)

  2. Zonulin

    Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks

    Serum

  3. Lipopolysaccharide binding protein (LBP)

    Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks

    Serum

  4. Toll like receptor-4 and Null 2 stimulation

    Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks

    serum and the HEK cell reporter assay

  5. Endotoxin in response to a meal

    Time frame: Change over 5 hour MMT

    Serum inflammatory response to a mixed meal tolerance test (MMT)

Other outcomes

  1. Change in Glucose in response to a meal

    Time frame: Change over 5 hour MMT

    Serum glycemic response to a meal

  2. Change in insulin in response to a meal

    Time frame: Change over 5 hour MMT

    Serum glycemic response to a meal

  3. Inflammatory markers in response to a meal

    Time frame: Change over 5 hour MMT

    serum TNF alpha, CRP and IL-6 (grams/volume)

  4. Lipopolysaccharide binding protein (LBP) in response to a meal

    Time frame: Change over 5 hour MMT

    serum

  5. Change in Triglycerides in response to a meal

    Time frame: Change over 5 hour MMT

    Serum lipid response to a meal (peak and AUC)

  6. Change in Osteocalcin in response to a meal

    Time frame: Change over 5 hour MMT

    Serum bone formation and energy metabolism marker

  7. Change in PINP in response to a meal

    Time frame: Change over 5 hour MMT

    Serum bone formation marker

  8. Change in CTX in response to a meal

    Time frame: Change over 5 hour MMT

    Serum bone resorption marker

  9. Change in diet quality score

    Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks

    Nutrient analysis and HEI (higher score is better)

  10. Body composition in lean and obese weight groups

    Time frame: baseline characteristics

    total tissue, fat-free soft tissue, fat, visceral adiposity

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Dietary Inflammation in Older Adults: the Role of Obesity

Acronym: LODI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2022
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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