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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese | Experimental | BMI in Obesity range |
|
| Normal weight (lean) | Experimental | Normal body weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Endotoxin from Low to High fat diet | serum and stool | Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks |
| Change in Microbiome composition | stool | Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers | Serum IL-6, hsCRP, TNF-alpha, TLR4 (grams/volume) | Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks |
| Zonulin | Serum |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glucose in response to a meal | Serum glycemic response to a meal | Change over 5 hour MMT |
| Change in insulin in response to a meal | Serum glycemic response to a meal |
Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Sue Shapses, PhD | Rutgers, the State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers University | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40480607 | Result | 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. |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2022 | Dec 1, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| D059305 | Diet, High-Fat |
| D004032 | Diet |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D009747 | Nutritional Physiological Phenomena |
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|
|
| 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 |
|
|
| Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks |
| Lipopolysaccharide binding protein (LBP) | Serum | 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 | 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) | Change over 5 hour MMT |
| Change over 5 hour MMT |
| Inflammatory markers in response to a meal | serum TNF alpha, CRP and IL-6 (grams/volume) | Change over 5 hour MMT |
| Lipopolysaccharide binding protein (LBP) in response to a meal | serum | Change over 5 hour MMT |
| Change in Triglycerides in response to a meal | Serum lipid response to a meal (peak and AUC) | Change over 5 hour MMT |
| Change in Osteocalcin in response to a meal | Serum bone formation and energy metabolism marker | Change over 5 hour MMT |
| Change in PINP in response to a meal | Serum bone formation marker | Change over 5 hour MMT |
| Change in CTX in response to a meal | Serum bone resorption marker | Change over 5 hour MMT |
| Change in diet quality score | Nutrient analysis and HEI (higher score is better) | Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks |
| Body composition in lean and obese weight groups | total tissue, fat-free soft tissue, fat, visceral adiposity | baseline characteristics |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |