LODI: Lean and Obese: Dietary Inflammation

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Recruiting
CT.gov ID
NCT05327868
Collaborator
(none)
24
1
2
22
1.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Low Fat Diet (LFD)
  • Other: High Fat Diet (HFD)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
Dietary Inflammation in Older Adults: the Role of Obesity
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Endotoxin from Low to High fat diet [Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks]

      serum and stool

    2. Change in Lipopolysaccharide binding protein [Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks]

      serum

    3. Change in Microbiome composition [Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks]

      stool

    Secondary Outcome Measures

    1. Change in Interleukin-6 [Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks]

      Serum IL6 (inflammatory marker)

    2. Change in hsCRP [Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks]

      Serum hsCRP (inflammatory marker)

    3. Change in Zonulin [Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks]

      Serum zonulin

    4. Change in Endotoxin in response to a meal [Change over 5 hour MMT]

      Serum inflammatory response to a mixed meal tolerance test (MMT)

    5. Change in lipopolysaccharide binding protein (LBP) in response to a meal [Change over 5 hour MMT]

      Serum inflammatory response to a meal

    6. Change in Glucose in response to a meal [Change over 5 hour MMT]

      Serum glycemic response to a meal

    7. Change in Insulin in response to a meal [Change over 5 hour MMT]

      Serum glycemic response to a meal

    8. Change in Triglycerides in response to a meal [Change over 5 hour MMTT]

      Serum lipid response to a meal

    Other Outcome Measures

    1. Change in PINP in response to a meal [Change over 5 hour MMT]

      Serum bone formation marker

    2. Change in Osteocalcin in response to a meal [Change over 5 hour MMTT]

      Serum bone formation and energy metabolism marker

    3. Change in CTX in response to a meal [Change over 5 hour MMTT]

      Serum bone resorption marker

    4. Change in Diet quality score [Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks]

      Nutrient analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Men or Women

    • Age 50-75 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rutgers University New Brunswick New Jersey United States 08901

    Sponsors and Collaborators

    • Rutgers, The State University of New Jersey

    Investigators

    • Principal Investigator: Sue Shapses, PhD, Rutgers, the State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sue A. Shapses, Ph.D., RD, Professor, Rutgers, The State University of New Jersey
    ClinicalTrials.gov Identifier:
    NCT05327868
    Other Study ID Numbers:
    • Pro2019002228
    First Posted:
    Apr 14, 2022
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sue A. Shapses, Ph.D., RD, Professor, Rutgers, The State University of New Jersey
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 14, 2022