Clinical trial NCT05327868: Lean and Obese: Dietary Inflammation
Official title: Dietary Inflammation in Older Adults: the Role of Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Inflammation
Dietary Fat
Keywords: obesity
lean individuals
older adults
microbiome
dietary fat
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Endotoxin from Low to High fat diet
timeFrame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
measure: Change in Microbiome composition
timeFrame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Secondary outcomes:
measure: Inflammatory markers
timeFrame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
measure: Zonulin
timeFrame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
measure: Lipopolysaccharide binding protein (LBP)
timeFrame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
measure: Toll like receptor-4 and Null 2 stimulation
timeFrame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
measure: Endotoxin in response to a meal
timeFrame: Change over 5 hour MMT
Other outcomes:
measure: Change in Glucose in response to a meal
timeFrame: Change over 5 hour MMT
measure: Change in insulin in response to a meal
timeFrame: Change over 5 hour MMT
measure: Inflammatory markers in response to a meal
timeFrame: Change over 5 hour MMT
measure: Lipopolysaccharide binding protein (LBP) in response to a meal
timeFrame: Change over 5 hour MMT
measure: Change in Triglycerides in response to a meal
timeFrame: Change over 5 hour MMT
measure: Change in Osteocalcin in response to a meal
timeFrame: Change over 5 hour MMT
measure: Change in PINP in response to a meal
timeFrame: Change over 5 hour MMT
measure: Change in CTX in response to a meal
timeFrame: Change over 5 hour MMT
measure: Change in diet quality score
timeFrame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
measure: Body composition in lean and obese weight groups
timeFrame: baseline characteristics
Locations:
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
affiliation: Rutgers, the State University
name: Sue Shapses, PhD
role: PRINCIPAL_INVESTIGATOR
References: