Lean and Obese: Dietary Inflammation

Obesity Clinical Trial

— LODI  

Official title:

Dietary Inflammation in Older Adults: the Role of Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05327868
• Other study ID #: Pro2019002228
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: February 11, 2023

Study information

• Verified date: March 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 11, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Fat
• Inflammation
• Obesity

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Rutgers University	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Glucose in response to a meal	Serum glycemic response to a meal	Change over 5 hour MMT
Other	Change in insulin in response to a meal	Serum glycemic response to a meal	Change over 5 hour MMT
Other	Inflammatory markers in response to a meal	serum TNF alpha, CRP and IL-6 (grams/volume)	Change over 5 hour MMT
Other	Lipopolysaccharide binding protein (LBP) in response to a meal	serum	Change over 5 hour MMT
Other	Change in Triglycerides in response to a meal	Serum lipid response to a meal (peak and AUC)	Change over 5 hour MMT
Other	Change in Osteocalcin in response to a meal	Serum bone formation and energy metabolism marker	Change over 5 hour MMT
Other	Change in PINP in response to a meal	Serum bone formation marker	Change over 5 hour MMT
Other	Change in CTX in response to a meal	Serum bone resorption marker	Change over 5 hour MMT
Other	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
Other	Body composition in lean and obese weight groups	total tissue, fat-free soft tissue, fat, visceral adiposity	baseline characteristics
Primary	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
Primary	Change in Microbiome composition	stool	Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Secondary	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
Secondary	Zonulin	Serum	Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Secondary	Lipopolysaccharide binding protein (LBP)	Serum	Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Secondary	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
Secondary	Endotoxin in response to a meal	Serum inflammatory response to a mixed meal tolerance test (MMT)	Change over 5 hour MMT