Clinical trial
Intermittent Cottonseed Oil Consumption
Recruiting now · Not applicable · 1 countries · Registry ID NCT07246408
What this study is about
Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. Cottonseed oil (CSO) is found readily in the food supply, and the investigator's previous studies have demonstrated that incorporating CSO into the diet is sufficient to improve fasting and postprandial blood lipids and other markers of chronic disease risk in both healthy and at-risk populations. This study aims to examine the impact of intermittent CSO consumption at different doses (consumed three times per week (3x/wk)) on changes in fasting and postprandial lipid metabolism/blood lipids and markers of chronic disease risk. The specific aims are: \*Examine the impact of intermittent CSO consumption (3x/week) at two different doses on fasting and postprandial lipids. \*Examine the impact of intermittent CSO consumption (3x/week) at two different doses on other markers of chronic disease risk. Participants will be asked to: \*Consume provided meal replacement shakes and snacks 3 times per week for 56 days. \*Attend three bi-weekly (every other week) short visits for fasting blood draws, body measurements, and collection of the next two weeks' study materials. \*Attend two longer (5.5h) testing visits, which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast. Researchers will compare CSO-30, CSO-20, and Control groups (receiving no oil) to see if intermittent CSO consumption imparts the same health benefits as previously shown with daily doses of CSO.
Basic eligibility
Full registry criteria
Treatments and study arms
CSO-30
Participants are provided a breakfast shake and snack to consume 3 times per week that meets 30% of participant's daily estimated energy needs as cottonseed oil for 56 days.
CSO-20
Participants are provided a breakfast shake and snack to consume 3 times per week that meets 20% of participant's daily estimated energy needs as cottonseed oil for 56 days.
Control
Participants are provided a breakfast shake and snack to consume 3 times per week that does not contain cottonseed oil, but does contain thickened water for blinding purposes, for 56 days.
Primary outcomes
The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, cholesterol/HDL ratio, and non-HDL cholesterol (mg/dL)
The concentration of plasma triglycerides before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mg/dL)
The concentration of plasma NEFAs before and after the high saturated fat meal challenge at both pre- and post-intervention visits (mEq/L)
The concentration of plasma appetite control hormones before and after the high saturated fat meal challenge at both pre- and post-intervention visits. Appetite control hormones include cholecystokinin (CCK), Peptide YY (PYY), and Ghrelin (pg/mL)
Visual analog scale ratings of feelings related to appetite before and after the high saturated fat meal challenge, and for the remainder of the day, at both pre- and post-intervention visits. Subjective feelings of hunger, fullness, desire to eat, prospective consumption, and a composite appetite score are measured by visual analog scales (mm).
The concentration of MDA before and after the high saturated fat meal challenge at both pre- and post-intervention visits (nmol/mL).
Total antioxidant capacity before and after the high saturated fat meal challenge at both pre- and post-intervention visits (U/mL).
The concentration of interleukin-1 beta, C-reactive protein, tumor-necrosis factor-alpha, interleukin-10, and interleukin-6 at fasting at both pre-and post-intervention visits (pg/mL).
Study locations
1 locations were listed when this page was built. The first 40 are shown.