ObesityLODINCT05327868
Lean and Obese: Dietary Inflammation
A study testing Low Fat Diet (LFD) and High Fat Diet (HFD) in people with Obesity and Inflammation, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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-over design in older adults (men and women) with normal body weight or obesity. Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Inflammation, Dietary Fat
- What is being tested?
- Low Fat Diet (LFD) and High Fat Diet (HFD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 11 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or Women
- Age 50-79 years (only postmenopausal women > 2 years)
- Body mass index (20-25 kg/m2; and 30-40 kg/m2)*
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Inflammation, Dietary Fat
- Being tested
- Low Fat Diet (LFD), High Fat Diet (HFD)
- Keywords
- obesity, lean individuals, older adults, microbiome, dietary fat
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Fat Diet (LFD)Other
Also called low fat diet
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
High Fat Diet (HFD)Other
Also called high fat (high SFA) diet
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
| Study group | Role | What they receive |
|---|---|---|
| Obese | Experimental | BMI in Obesity range Receives: Other: Low Fat Diet (LFD); Other: High Fat Diet (HFD) |
| Normal weight (lean) | Experimental | Normal body weight Receives: Other: Low Fat Diet (LFD); Other: High Fat Diet (HFD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endotoxin from Low to High fat diet
serum and stool
Measured: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Change in Microbiome composition
stool
Measured: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Secondary outcomes (5)
Inflammatory markers
Serum IL-6, hsCRP, TNF-alpha, TLR4 (grams/volume)
Measured: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Zonulin
Serum
Measured: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Lipopolysaccharide binding protein (LBP)
Serum
Measured: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Toll like receptor-4 and Null 2 stimulation
serum and the HEK cell reporter assay
Measured: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Endotoxin in response to a meal
Serum inflammatory response to a mixed meal tolerance test (MMT)
Measured: Change over 5 hour MMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Mar 2022
- Primary completion1 Jan 2023
- Study completion11 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue A. Shapses, Ph.D., RD, Rutgers, The State University of New Jersey
- Investigators
- Sue Shapses, PhD, Principal investigator, Rutgers, the State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327868
- Sponsor's protocol ID
- Pro2019002228
- Acronym
- LODI
- Status last verified
- May 2026
- First submitted
- 28 Feb 2022
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Publications
Ogilvie AR, Onishi JC, Schlussel Y, Kumar A, Haggblom MM, Kerkhof LJ, Shapses SA. Short-term high fat diet-induced metabolic endotoxemia in older individuals with obesity: a randomized crossover study. Am J Clin Nutr. 2025 Aug;122(2):601-611. doi: 10.1016/j.ajcnut.2025.06.001. Epub 2025 Jun 4.
PubMed 40480607
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Inflammation in Older Adults: the Role of Obesity
- ClinicalTrials.gov ID
- NCT05327868
- Acronym / sponsor ID
- LODI / Pro2019002228
- Conditions
- Obesity, Inflammation, Dietary Fat
- Keywords
- obesity, lean individuals, older adults, microbiome, dietary fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 11 Feb 2023 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese | Experimental | Other: Low Fat Diet (LFD), Other: High Fat Diet (HFD)BMI in Obesity range |
| Normal weight (lean) | Experimental | Other: Low Fat Diet (LFD), Other: High Fat Diet (HFD)Normal body weight |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or Women
- Age 50-79 years (only postmenopausal women > 2 years)
- Body mass index (20-25 kg/m2; and 30-40 kg/m2)*
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Fat Diet (LFD)Also: low fat dietSubjects 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 | Normal weight (lean), Obese |
| High Fat Diet (HFD)Also: high fat (high SFA) dietSubjects 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 | Normal weight (lean), Obese |
Primary outcome
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 in Microbiome composition
Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
stool
5 secondary outcomes
Inflammatory markers
Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Zonulin
Time frame: 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
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
Endotoxin in response to a meal
Time frame: Change over 5 hour MMT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Results publication: PubMed 40480607Ogilvie AR, Onishi JC, Schlussel Y, Kumar A, Haggblom MM, Kerkhof LJ, Shapses SA. Short-term high fat diet-induced metabolic endotoxemia in older individuals with obesity: a randomized crossover study. Am J Clin Nutr. 2025 Aug;122(2):601-611. doi: 10.1016/j.ajcnut.2025.06.001. Epub 2025 Jun 4.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue Shapses, PhD principal investigator
Rutgers, the State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Fat Diet (LFD) and High Fat Diet (HFD) in people with Obesity and Inflammation, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05327868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.