Lean and Obese: Dietary Inflammation

NCT05327868 | Completed

• 1 other identifier: Pro2019002228
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. Inflammation will be examined by measuring serum endotoxin and other markers, as well as the fecal microbiota.

Conditions

Obesity; Inflammation; Dietary Fat

Keywords

obesity; lean individuals; older adults; microbiome; dietary fat

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Inflammatory markers

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

• Zonulin

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

• Lipopolysaccharide binding protein (LBP)

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

• Toll like receptor-4 and Null 2 stimulation

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

• Endotoxin in response to a meal

  Change over 5 hour MMT

Other Outcomes (10)

• Change in Glucose in response to a meal

  Change over 5 hour MMT

• Change in insulin in response to a meal

  Change over 5 hour MMT

• Inflammatory markers in response to a meal

  Change over 5 hour MMT

Study Arms (2)

Obese

EXPERIMENTAL

BMI in Obesity range

Other: Low Fat Diet (LFD); Other: High Fat Diet (HFD)

Normal weight (lean)

EXPERIMENTAL

Normal body weight

Other: Low Fat Diet (LFD); Other: High Fat Diet (HFD)

Interventions

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

Also known as: low fat diet

Normal weight (lean); Obese

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

Also known as: high fat (high SFA) diet

Normal weight (lean); Obese

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or Women
• Age 50-79 years (only postmenopausal women \> 2 years)
• Body mass index (20-25 kg/m2; and 30-40 kg/m2)\*

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

• 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.

  PMID: 40480607 DERIVED

MeSH Terms

Conditions

Obesity; Inflammation

Interventions

Diet, Fat-Restricted; Diet, High-Fat; Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sue Shapses, PhD

  Rutgers, the State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: April 14, 2022
• Study Start: March 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: February 11, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)