Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27103, United States
NCT Number: NCT02962128
A randomized, clinical trial to provide the first comprehensive investigation of the role of fatty acid desaturate (FADS) genetic determinants on PUFA biosynthesis and metabolism as well as levels of inflammatory markers in a controlled dietary environment using two (low and high linoleic acid) parallel diets.
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Notify Me21 year–65 year
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27103, United States
Participants will be provided (weekly) with food items containing most of (>90%) the daily dietary fat (25-30% of daily calories) to be consumed. All study-supplied foods will be prepared by or acquired by the Wake Forest University Health Sciences (WFUHS) Clinical Research Unit (CRU) Metabolic Kitchen and distributed by the same. These foods will include smoothies (containing flaxseed oil common to both arms), and arm-dependent oil-based condiments (salad dressing, mayonnaise, and margarine) and prepared snack foods, each made with the arm-specific oil, as well as several packaged snacks and food items. Participants will be provided meal plans and recipes for home preparation of meals that will allow them to adhere to the target fatty acid contents of the two dietary arms. The goal of the dietary intervention is to provide participants with the daily fat content of their diet (25-30% of the daily calories) and to educate the participant to select and consume the balance of nutrients (60-75% of daily calories) derived from non-fat/low-fat containing foods.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Volunteers will be randomly assigned to consumption of a high [10% energy] LA-containing diet for 12 weeks.
Volunteers will be randomly assigned to consumption of a low [2.5% energy] LA-containing diet for 12 weeks.
Time frame: 12 Weeks for Each Volunteer
The primary outcome is the measurement of the change in PUFAs at 12 weeks. Biological specimens (urine and blood) will be collected from each subject at the beginning of the dietary intervention and at 4 week intervals. The primary outcome will be the measured difference between baseline and final PUFA levels before and after the diet.
Time frame: 12 Weeks for Each Volunteer
Secondary outcomes will be quantified in mg/dL and assessed using standard methods in an accredited clinical laboratory.
Time frame: 12 Weeks for Each Volunteer
The biochemical endpoints will be measured using established protocols
Wake Forest University Health Sciences
Other
Role of PUFA-Gene Interactions in Health Disparities
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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.