- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04397055
Oil Consumption and Cholesterol
Comparison of Blood Lipids From Diets Enriched With Cottonseed Oil Versus Olive Oil in Adults With High Cholesterol
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a single-blind, randomized controlled trial. Investigators recruited subjects with hypercholesterolemia (high blood cholesterol levels). Subjects were randomized into one of two groups: (1) Cottonseed oil (CSO), (2) Olive oil (OO). The interventions consist of identical foods that are only different in the respective oil they are prepared with.
There was a screening visit and 3 testing visits: Baseline (visit 2), mid-visit at week 4 (visit 6), and post-visit at week 8 (visit 10). Anthropometrics, questionnaires, and a fasting blood sample were collected at each visit. At visits 2 and 10 participants participated in a saturated fatty acid meal challenge in which additional blood and metabolism measurements were collected. Visits 3-9 represent weekly meal pickups, with the exception of visit 6 which is also a testing visit.
Hypothesis: Investigators hypothesized that enrichment of the diet with CSO would result in significantly greater improvements in blood lipids, metabolism, and appetite compared to the OO group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30605
- University of Georgia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 30-75 year old
- body mass index (BMI) between 18.5-39.9 kg/m2
- higher cholesterol levels indicated by "At Risk/Borderline High" in two or more of the variables (total cholesterol: 180-239 mg/dL, LDL cholesterol 110-159 mg/dL, triglycerides 130-199 mg/dL) or "High" in either total cholesterol (240 mg/dL and higher) or LDL (160 mg/dL or higher), and having triglyceride levels less than 350mg/dL.
Exclusion Criteria:
- participants with familial hypercholesterolemia
- LDL levels greater than the 95th percentile based on age and sex
- HDL levels lower than the 20th percentile based on age and sex
- women on hormone replacement therapy for less than 2 years
- individuals who regularly exercise more than 3 h/w
- weight gain or loss more than 5% of their body weight in the past 3 months
- plans to begin a weight loss/exercise regiment during the trial
- history of medical or surgical events that could affect digestion or swallowing
- gastrointestinal surgeries
- conditions or disorders
- any chronic or metabolic diseases
- atherosclerosis
- previous MI or stroke
- cancer
- fasting blood glucose levels greater than 126 mg/dL
- blood pressure greater than 180/120 mmHg
- medication use affecting digestion and absorption
- medication use affecting metabolism (e.g. thyroid meds)
- lipid-lowering medications
- medications for diabetes
- steroid/hormone therapies
- a medically prescribed or special diet
- food allergies (specific for the foods made in the study)
- taking fish oil and calciumfloroboron supplements
- excessive alcohol use (greater than 3 drinks/d for men; greater than 2 drinks/d for women)
- tobacco or nicotine use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cottonseed Oil
Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance
|
Participants are provided about 60% of their required energy for 8 weeks as foods from a 5 day cycle menu that are enriched with Cottonseed Oil
|
Active Comparator: Olive Oil
Participants are given foods enriched with olive oil and instructed on how to substitute study foods into their diet to maintain caloric balance
|
Participants are provided about 60% of their required energy for 8 weeks as foods from a 5 day cycle menu that are enriched with Olive Oil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in baseline fasting blood lipids at weeks 4 and 8
Time Frame: Baseline, 4 weeks, 8 weeks
|
Total Cholesterol (mg/dL), high-density lipoprotein (HDL) cholesterol (mg/dL), triglycerides (mg/dL), low-density lipoprotein (LDL) cholesterol (mg/dL), apolipoprotein B (mg/dL)
|
Baseline, 4 weeks, 8 weeks
|
Change in baseline lipoprotein (a), lipoprotien particle number and size at weeks 4 and 8
Time Frame: Baseline, 4 weeks, 8 weeks
|
Low density lipoprotien (LDL) particle number (nmol/L), LDL small (nmol/L), HDL large (nmol/L), LDL medium (nmol/L), lipoprotein (a) (nmol/L).
|
Baseline, 4 weeks, 8 weeks
|
Change in baseline low density lipoprotien (LDL) peak size at weeks 4 and 8
Time Frame: Baseline, 4 weeks, 8 weeks
|
LDL peak size (angstrom)
|
Baseline, 4 weeks, 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Baseline Blood Concentration of Hunger and Satiety Hormones over 8 weeks
Time Frame: measured at weeks 1 and 8 at fasting and for 5 hours postprandially
|
Blood samples will be collected to measure Peptide tyrosine tyrosine (YY) (pg/mL), Cholecystokinin (CCK) (pg/mL), Ghrelin (pg/mL), Glucagon-like peptide 1 (GLP1) (pg/mL)
|
measured at weeks 1 and 8 at fasting and for 5 hours postprandially
|
Change in Height over 8 weeks
Time Frame: measured at weeks 1, 4, and 8 at fasting
|
Height measured in centimetres
|
measured at weeks 1, 4, and 8 at fasting
|
Change in weight over 8 weeks
Time Frame: measured at weeks 1, 4, and 8 at fasting
|
weight measured in pounds and kilograms
|
measured at weeks 1, 4, and 8 at fasting
|
change in blood pressure over 8 weeks
Time Frame: measured at weeks 1, 4, and 8 at fasting
|
both systolic and diastolic blood pressure measured in millimetres of mercury (mmHg)
|
measured at weeks 1, 4, and 8 at fasting
|
change in waist circumference over 8 weeks
Time Frame: measured at weeks 1, 4, and 8 at fasting
|
waist circumference measured in centimetres
|
measured at weeks 1, 4, and 8 at fasting
|
change in hip circumference over 8 weeks
Time Frame: measured at weeks 1, 4, and 8 at fasting
|
hip circumference measured in centimetres
|
measured at weeks 1, 4, and 8 at fasting
|
change in total body fat percentage over 8 weeks
Time Frame: measured at weeks 1, 4, and 8 at fasting
|
total body fat percentage measured as percent of total body mass
|
measured at weeks 1, 4, and 8 at fasting
|
change in Blood glucose concentration responses (glycemia) over 8 weeks
Time Frame: measured at week 1 and 8 at fasting and for 5 hours postprandially
|
blood samples are collected to measure blood glucose concentration (mg/dL) in response to saturated fatty acid meal
|
measured at week 1 and 8 at fasting and for 5 hours postprandially
|
change in Blood insulin concentration responses (glycemia) over 8 weeks
Time Frame: measured at week 1 and 8 at fasting and for 5 hours postprandially
|
blood samples are collected to measure blood insulin concentration (uU/mL) in response to saturated fatty acid meal
|
measured at week 1 and 8 at fasting and for 5 hours postprandially
|
change in blood triglyceride meal responses over 8 weeks
Time Frame: measured at week 1 and 8 at fasting and for 5 hours postprandially
|
Triglyceride (mg/dL) response to saturated fatty acid meal
|
measured at week 1 and 8 at fasting and for 5 hours postprandially
|
change in non-esterified free fatty acid (NEFA) meal responses over 8 weeks
Time Frame: measured at week 1 and 8 at fasting and for 5 hours postprandially
|
NEFA (mEq/dL) response to saturated fatty acid meal
|
measured at week 1 and 8 at fasting and for 5 hours postprandially
|
change in Fat oxidation over 8 weeks
Time Frame: measured at week 1 and 8 at fasting and for 3.5 hours postprandially
|
measured (g/hr) via indirect calorimetry
|
measured at week 1 and 8 at fasting and for 3.5 hours postprandially
|
change in Carbohydrate oxidation over 8 weeks
Time Frame: measured at week 1 and 8 at fasting and for 3.5 hours postprandially
|
measured (g/hr) via indirect calorimetry
|
measured at week 1 and 8 at fasting and for 3.5 hours postprandially
|
change in Resting metabolic rate (RMR) over 8 weeks
Time Frame: measured at week 1 and 8 at fasting and for 3.5 hours postprandially
|
RMR (kcals/d) measured via indirect calorimetry
|
measured at week 1 and 8 at fasting and for 3.5 hours postprandially
|
change in Respiratory exchange ratio (RER) over 8 weeks
Time Frame: measured at week 1 and 8 at fasting and for 3.5 hours postprandially
|
measured (VCO2/Vo2) via indirect calorimetry
|
measured at week 1 and 8 at fasting and for 3.5 hours postprandially
|
change in subjective appetite over 8 weeks
Time Frame: measured at week 1 and 8 at fasting and for 5 hours postprandially in 30 minuet intervals; also measured once per hour after the subject leaves the lab until they go to bed
|
hunger, fullness, prospective consumption, and desire to eat measured via a Visual Analog Scale (VAS).
VAS uses an unmarked 10 centimetre line and asks the subject to answer the connected question by placing a tick mark on the line as though it is a spectrum from 0 to 100 percent with the right being in the most agreement (i.e.
extremely hungry in response to how hungry are you) and the left being the most disagreement (i.e.
extremely not hungry in response to how hungry are you).
Answers will be measured in centimetres in response to questions about hunger, fullness, prospective consumption, and desire to eat.
|
measured at week 1 and 8 at fasting and for 5 hours postprandially in 30 minuet intervals; also measured once per hour after the subject leaves the lab until they go to bed
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Perceived Stress over 8 weeks
Time Frame: measured at week 1, 4, and 8 at fasting
|
perceived Stress Scale is a questionnaire asking 10 questions about the subject's feelings of stress in the past month.
There are 5 possible answers, never, almost never, sometimes, fairly often, very often with corresponding scores of 0 - 4 respectively.
Scores for all questions will be added up as in indication of stress level.
Higher perceived stress scale scores correspond to higher stress levels.
|
measured at week 1, 4, and 8 at fasting
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Prater MC, Scheurell AR, Paton CM, Cooper JA. Metabolic responses to 8 weeks of consuming cottonseed oil versus olive oil in adults with dyslipidaemia: a randomised trial. J Hum Nutr Diet. 2022 Sep 3. doi: 10.1111/jhn.13085. Online ahead of print.
- Prater MC, Scheurell AR, Paton CM, Cooper JA. Blood Lipid Responses to Diets Enriched with Cottonseed Oil Compared With Olive Oil in Adults with High Cholesterol in a Randomized Trial. J Nutr. 2022 Sep 6;152(9):2060-2071. doi: 10.1093/jn/nxac099.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00005869
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypercholesterolemia
-
National Medical Research Center for Therapy and...Moscow State University of Medicine and DentistryRecruitingMedication Adherence | Adherence, Medication | Treatment Adherence | Familial Hypercholesterolemia | Motivational Interviewing | Adherence, Patient | Treatment Adherence and Compliance | Patient Compliance | Adherence | Hypercholesterolemia, Familial | Patient Adherence | Hypercholesterolemia, Autosomal Dominant and other conditionsRussian Federation
-
Direct PlantesUnknownHYPERCHOLESTEROLEMIAFrance
-
Chong Kun Dang PharmaceuticalRecruitingPrimary HypercholesterolemiaKorea, Republic of
-
Addpharma Inc.CompletedPrimary HypercholesterolemiaKorea, Republic of
-
JW PharmaceuticalCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Provident Clinical ResearchGlaxoSmithKlineUnknownPrimary HypercholesterolemiaUnited States
-
Organon and CoCompletedPrimary Hypercholesterolemia | Homozygous Familial Hypercholesterolemia
-
Boryung Pharmaceutical Co., LtdRecruitingPrimary HypercholesterolemiaKorea, Republic of
-
Ahn-Gook Pharmaceuticals Co.,LtdRecruitingPrimary HypercholesterolemiaKorea, Republic of
Clinical Trials on Cottonseed Oil
-
Regenera Pharma LtdCompletedMild to Moderate Dementia Due to Alzheimer's Disease | With or Without Coexisting Cerebrovascular DiseaseCanada
-
Penn State UniversityCotton IncorporatedNot yet recruitingCardiovascular Diseases
-
University of GeorgiaUnited States Department of Agriculture (USDA)Not yet recruitingDyslipidemia | Overweight and Obesity | Nutrition, HealthyUnited States
-
Regenera Pharma LtdTerminatedNonarteritic Anterior Ischemic Optic NeuropathyUnited States
-
Harvard School of Public Health (HSPH)CompletedCardiovascular Disease
-
Wolfson Medical CenterUnknownDystonia | SpasticityIsrael
-
Stony Brook UniversitySuspendedBack Pain | Sciatica | Back Pain, LowUnited States
-
Réseau de Santé Vitalité Health NetworkCompleted
-
DSM Nutritional Products, Inc.Completed
-
Yonsei UniversityCompletedHyperlipidemias | Triglycerides HighKorea, Republic of