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Lean and Obese: Dietary Inflammation (LODI)

Primary Purpose

Obesity, Inflammation, Dietary Fat

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Fat Diet (LFD)
High Fat Diet (HFD)
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring obesity, lean individuals, older adults, microbiome, dietary fat

Eligibility Criteria

50 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rutgers University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Obese

Normal weight (lean)

Arm Description

BMI in Obesity range

Normal body weight

Outcomes

Primary Outcome Measures

Change in Endotoxin from Low to High fat diet
serum and stool
Change in Lipopolysaccharide binding protein
serum
Change in Microbiome composition
stool

Secondary Outcome Measures

Change in Interleukin-6
Serum IL6 (inflammatory marker)
Change in hsCRP
Serum hsCRP (inflammatory marker)
Change in Zonulin
Serum zonulin
Endotoxin in response to a meal
Serum inflammatory response to a mixed meal tolerance test (MMT) (peak and AUC)
Lipopolysaccharide binding protein (LBP) in response to a meal
Serum inflammatory response to a MMT (peak and AUC)
Change in Glucose in response to a meal
Serum glycemic response to a meal
Change in Insulin in response to a meal
Serum glycemic response to a meal
Change in Triglycerides in response to a meal
Serum lipid response to a meal

Full Information

First Posted
February 28, 2022
Last Updated
March 31, 2023
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT05327868
Brief Title
Lean and Obese: Dietary Inflammation
Acronym
LODI
Official Title
Dietary Inflammation in Older Adults: the Role of Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
February 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Inflammation, Dietary Fat
Keywords
obesity, lean individuals, older adults, microbiome, dietary fat

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obese
Arm Type
Experimental
Arm Description
BMI in Obesity range
Arm Title
Normal weight (lean)
Arm Type
Experimental
Arm Description
Normal body weight
Intervention Type
Other
Intervention Name(s)
Low Fat Diet (LFD)
Other Intervention Name(s)
low fat diet
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
High Fat Diet (HFD)
Other Intervention Name(s)
high fat (high SFA) diet
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Endotoxin from Low to High fat diet
Description
serum and stool
Time Frame
Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Title
Change in Lipopolysaccharide binding protein
Description
serum
Time Frame
Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Title
Change in Microbiome composition
Description
stool
Time Frame
Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Secondary Outcome Measure Information:
Title
Change in Interleukin-6
Description
Serum IL6 (inflammatory marker)
Time Frame
Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Title
Change in hsCRP
Description
Serum hsCRP (inflammatory marker)
Time Frame
Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Title
Change in Zonulin
Description
Serum zonulin
Time Frame
Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Title
Endotoxin in response to a meal
Description
Serum inflammatory response to a mixed meal tolerance test (MMT) (peak and AUC)
Time Frame
Change over 5 hour MMT
Title
Lipopolysaccharide binding protein (LBP) in response to a meal
Description
Serum inflammatory response to a MMT (peak and AUC)
Time Frame
Change over 5 hour MMT
Title
Change in Glucose in response to a meal
Description
Serum glycemic response to a meal
Time Frame
Change over 5 hour MMT
Title
Change in Insulin in response to a meal
Description
Serum glycemic response to a meal
Time Frame
Change over 5 hour MMT
Title
Change in Triglycerides in response to a meal
Description
Serum lipid response to a meal
Time Frame
Change over 5 hour MMT
Other Pre-specified Outcome Measures:
Title
Change in PINP in response to a meal
Description
Serum bone formation marker
Time Frame
Change over 5 hour MMT
Title
Change in Osteocalcin in response to a meal
Description
Serum bone formation and energy metabolism marker
Time Frame
Change over 5 hour MMT
Title
Change in CTX in response to a meal
Description
Serum bone resorption marker
Time Frame
Change over 5 hour MMT
Title
Change in Diet quality score
Description
Nutrient analysis
Time Frame
Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Title
Body composition in lean and obese weight groups
Description
total tissue, fat-free soft tissue, fat, visceral adiposity
Time Frame
baseline characteristics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Shapses, PhD
Organizational Affiliation
Rutgers, the State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Lean and Obese: Dietary Inflammation

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