Rutgers University
New Brunswick, New Jersey, 08901, United States
NCT Number: NCT05327868
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.
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Notify Me50 year–79 year
All sexes
Interventional
Not applicable
New Brunswick, New Jersey, 08901, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
serum and stool
Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
stool
Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Serum IL-6, hsCRP, TNF-alpha, TLR4 (grams/volume)
Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Serum
Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Serum
Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
serum and the HEK cell reporter assay
Time frame: Change over 5 hour MMT
Serum inflammatory response to a mixed meal tolerance test (MMT)
Time frame: Change over 5 hour MMT
Serum glycemic response to a meal
Time frame: Change over 5 hour MMT
Serum glycemic response to a meal
Time frame: Change over 5 hour MMT
serum TNF alpha, CRP and IL-6 (grams/volume)
Time frame: Change over 5 hour MMT
serum
Time frame: Change over 5 hour MMT
Serum lipid response to a meal (peak and AUC)
Time frame: Change over 5 hour MMT
Serum bone formation and energy metabolism marker
Time frame: Change over 5 hour MMT
Serum bone formation marker
Time frame: Change over 5 hour MMT
Serum bone resorption marker
Time frame: Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks
Nutrient analysis and HEI (higher score is better)
Time frame: baseline characteristics
total tissue, fat-free soft tissue, fat, visceral adiposity
Rutgers, The State University of New Jersey
Other
Dietary Inflammation in Older Adults: the Role of Obesity
Acronym: LODI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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