Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382298
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-19
Brief Title:
Cottonseed Oil Versus Matched PUFA Effects
Sponsor:
University of Georgia
Organization:
University of Georgia
Study Overview
Official Title:
Health Effects of Cottonseed Oil Versus Matched Composition Diets in Humans
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 investigators previous studies have demonstrated that incorporating CSO into the diet is sufficient to improve fasting cholesterol profile and improve postprandial lipid andor glycemic responses in both healthy and at-risk populations This study aims to compare CSO to a fatty acid composition-matched diet on changes in fasting and postprandial lipid metabolism and markers of chronic disease risk
The specific aims are
Examine the impact of CSO vs PUFA on fasting and postprandial lipids
Examine the impact of CSO on other markers of chronic disease risk
Participants will be asked to
Consume provided meal replacement shakes daily for 28-days
Attend three weekly short visits for fasting blood draws body measurements and collect the next week of study materials
Attend two longer 55h testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast
Researchers will compare CSO vs PUFA and control groups receiving a mixture of oils to see if CSO is unique in imparting health benefits when compared with similar matched oil diets
The specific aims are
Examine the impact of CSO vs PUFA on fasting and postprandial lipids
Examine the impact of CSO on other markers of chronic disease risk
Participants will be asked to
Consume provided meal replacement shakes daily for 28-days
Attend three weekly short visits for fasting blood draws body measurements and collect the next week of study materials
Attend two longer 55h testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast
Researchers will compare CSO vs PUFA and control groups receiving a mixture of oils to see if CSO is unique in imparting health benefits when compared with similar matched oil diets
Detailed Description:
Accounting for nearly 1 in every 4 deaths in the US cardiovascular disease CVD is the leading cause of death for adults One risk factor for CVD is hypercholesterolemia which can double the risk for this disease Cottonseed oil is a rich source of poly-unsaturated fatty acids PUFAs Despite having a relatively high amount of saturated fatty acids preliminary studies demonstrate that incorporating CSO into a diet is sufficient to reduce blood lipid profiles and select postprandial measures of metabolism These improvements in lipid metabolism may be due to the general fatty acid FA composition of CSO however evidence shows that a fatty acid unique to CSO dihydrosterculic acid DHSA may be responsible for some if not all the positive lipid lowering effects
This prospective clinical study is a double-blinded randomized control trial in adults at increased risk for cardiovascular disease poor cholesterol profiles or overweightobesity There are three diet interventions CSO 20 energy needs from CSO matched-PUFA 20 energy needs from non-CSO matched PUFA sources and Control 20 of energy needs from control oil mixture representative of the average fatty acid composition consumed by US adults The study protocol consists of a 28-day intervention where participants are provided breakfast shakes that contain a different oil or mixture of oils depending on the participants random group assignment
There are a total of 6 testing visits screening v0 pre-intervention v1 3 weekly short visits v2 v3 v4 and post-intervention v5
At screening v0 qualification is confirmed based on anthropometrics and fasting blood draw which is analyzed for a cholesterol panel and blood glucose Additionally energy requirements are estimated at this visit for use in the diet intervention
At v1 participants will have anthropometrics measured including body composition by dual-energy x-ray absorptiometry DXA Fasting and postprandial blood draws for a 5h period will occur following a high saturated-fat meal challenge which delivers 35 of the participants estimated energy needs
28-day dietary intervention Participants will consume a daily shake corresponding to the participants randomly assigned group The ingredients for the breakfast shakes are identical between groups the only difference being the composition of assigned oil provided The breakfast shakes are portioned based on individual energy needs as estimated at v0
Participants return weekly v2 v3 v4 to return study materials and collect shakes for the next week At these weekly visits participants also have a fasting blood draw body measures and consume the daily breakfast shake in the lab
At the end of the 28-day dietary intervention participants return for v5 where all procedures from v1 are repeated
The investigators hypothesize that CSO will improve the proposed overall health outcomes and markers of chronic disease risk when compared with the matched PUFA and control groups
This prospective clinical study is a double-blinded randomized control trial in adults at increased risk for cardiovascular disease poor cholesterol profiles or overweightobesity There are three diet interventions CSO 20 energy needs from CSO matched-PUFA 20 energy needs from non-CSO matched PUFA sources and Control 20 of energy needs from control oil mixture representative of the average fatty acid composition consumed by US adults The study protocol consists of a 28-day intervention where participants are provided breakfast shakes that contain a different oil or mixture of oils depending on the participants random group assignment
There are a total of 6 testing visits screening v0 pre-intervention v1 3 weekly short visits v2 v3 v4 and post-intervention v5
At screening v0 qualification is confirmed based on anthropometrics and fasting blood draw which is analyzed for a cholesterol panel and blood glucose Additionally energy requirements are estimated at this visit for use in the diet intervention
At v1 participants will have anthropometrics measured including body composition by dual-energy x-ray absorptiometry DXA Fasting and postprandial blood draws for a 5h period will occur following a high saturated-fat meal challenge which delivers 35 of the participants estimated energy needs
28-day dietary intervention Participants will consume a daily shake corresponding to the participants randomly assigned group The ingredients for the breakfast shakes are identical between groups the only difference being the composition of assigned oil provided The breakfast shakes are portioned based on individual energy needs as estimated at v0
Participants return weekly v2 v3 v4 to return study materials and collect shakes for the next week At these weekly visits participants also have a fasting blood draw body measures and consume the daily breakfast shake in the lab
At the end of the 28-day dietary intervention participants return for v5 where all procedures from v1 are repeated
The investigators hypothesize that CSO will improve the proposed overall health outcomes and markers of chronic disease risk when compared with the matched PUFA and control groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None