Lean and Obese: Dietary Inflammation (LODI)

May 8, 2026 updated by: Sue A. Shapses, Ph.D., RD, Rutgers, The State University of New Jersey

Dietary Inflammation in Older Adults: the Role of Obesity

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers University

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Obese
BMI in Obesity range
Other: Low Fat Diet (LFD)
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
Other: High Fat Diet (HFD)
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
Experimental: Normal weight (lean)
Normal body weight
Other: Low Fat Diet (LFD)
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
Other: High Fat Diet (HFD)
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Change in Microbiome composition
Time Frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
stool
Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Lipopolysaccharide binding protein (LBP)
Time Frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Serum
Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
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
Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Endotoxin in response to a meal
Time Frame: Change over 5 hour MMT
Serum inflammatory response to a mixed meal tolerance test (MMT)
Change over 5 hour MMT
Zonulin
Time Frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Serum
Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Glucose in response to a meal
Time Frame: Change over 5 hour MMT
Serum glycemic response to a meal
Change over 5 hour MMT
Change in PINP in response to a meal
Time Frame: Change over 5 hour MMT
Serum bone formation marker
Change over 5 hour MMT
Change in Osteocalcin in response to a meal
Time Frame: Change over 5 hour MMT
Serum bone formation and energy metabolism marker
Change over 5 hour MMT
Change in CTX in response to a meal
Time Frame: Change over 5 hour MMT
Serum bone resorption marker
Change over 5 hour MMT
Body composition in lean and obese weight groups
Time Frame: baseline characteristics
total tissue, fat-free soft tissue, fat, visceral adiposity
baseline characteristics
Change in Triglycerides in response to a meal
Time Frame: Change over 5 hour MMT
Serum lipid response to a meal (peak and AUC)
Change over 5 hour MMT
Change in insulin in response to a meal
Time Frame: Change over 5 hour MMT
Serum glycemic response to a meal
Change over 5 hour MMT
Inflammatory markers in response to a meal
Time Frame: Change over 5 hour MMT
serum TNF alpha, CRP and IL-6 (grams/volume)
Change over 5 hour MMT
Lipopolysaccharide binding protein (LBP) in response to a meal
Time Frame: Change over 5 hour MMT
serum
Change over 5 hour MMT
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)
Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sue Shapses, PhD, Rutgers, The State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2019002228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data that underlie the results and after deidentification will be shared upon request for researchers who provide a methodologically sound proposal (and IRB approved).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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