Oil Consumption and Cholesterol

Study Overview
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Brief Summary
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More than 31 million U.S. adults have high total cholesterol and over 73 million U.S. adults have high LDL cholesterol. Cottonseed oil (CSO) is found readily in our food supply, and recent research has shown improvements in blood lipids following CSO consumption in healthy adults with normal cholesterol profiles. To date, however, there are no published studies on the effects of CSO-enriched diets on blood lipids and markers of health in an older population with hypercholesterolemia. Therefore, the purpose of this study is to test the health effects of a diet rich in CSO against a diet rich in olive oil to determine if the CSO-enriched diet will show greater improvements in blood lipids and other health markers in adults with high cholesterol levels. If CSO in the diet is found to improve these markers, these study findings could lead to improvements in health.

Detailed Description
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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.

Official Title
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Comparison of Blood Lipids From Diets Enriched With Cottonseed Oil Versus Olive Oil in Adults With High Cholesterol

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Cottonseed Oil
* Dietary Supplement: Olive Oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 8 week parallel feeding trials of diets rich in Cottonseed oil or Olive Oil
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cottonseed Oil<br>Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance | Dietary Supplement: Cottonseed Oil<br>* 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<br>|
| Active Comparator: Olive Oil<br>Participants are given foods enriched with olive oil and instructed on how to substitute study foods into their diet to maintain caloric balance | Dietary Supplement: Olive Oil<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline fasting blood lipids at weeks 4 and 8 | 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 | 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 | 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 | 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 | Height measured in centimetres | measured at weeks 1, 4, and 8 at fasting | 
| Change in weight over 8 weeks | weight measured in pounds and kilograms | measured at weeks 1, 4, and 8 at fasting | 
| change in blood pressure over 8 weeks | 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 | waist circumference measured in centimetres | measured at weeks 1, 4, and 8 at fasting | 
| change in hip circumference over 8 weeks | hip circumference measured in centimetres | measured at weeks 1, 4, and 8 at fasting | 
| change in total body fat percentage over 8 weeks | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |