Hypercholesterolemia
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTCottonseed Oil
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
DIETARY_SUPPLEMENTOlive Oil
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
Sponsors
National Cottonseed Products Association
Cotton Incorporated
University of Georgia Obesity Initiative
University of Georgia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants are blinded to which oil they are receiving
Intervention model description
8 week parallel feeding trials of diets rich in Cottonseed oil or Olive Oil
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline low density lipoprotien (LDL) peak size at weeks 4 and 8 | Baseline, 4 weeks, 8 weeks | LDL peak size (angstrom) |
| Change in baseline fasting blood lipids at weeks 4 and 8 | 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) |
| Change in baseline lipoprotein (a), lipoprotien particle number and size at weeks 4 and 8 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight over 8 weeks | measured at weeks 1, 4, and 8 at fasting | weight measured in pounds and kilograms |
| change in blood pressure over 8 weeks | measured at weeks 1, 4, and 8 at fasting | both systolic and diastolic blood pressure measured in millimetres of mercury (mmHg) |
| change in waist circumference over 8 weeks | measured at weeks 1, 4, and 8 at fasting | waist circumference measured in centimetres |
| change in hip circumference over 8 weeks | measured at weeks 1, 4, and 8 at fasting | hip circumference measured in centimetres |
| change in total body fat percentage over 8 weeks | measured at weeks 1, 4, and 8 at fasting | total body fat percentage measured as percent of total body mass |
| change in Blood glucose concentration responses (glycemia) over 8 weeks | 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 |
| change in Blood insulin concentration responses (glycemia) over 8 weeks | 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 |
| change in non-esterified free fatty acid (NEFA) meal responses over 8 weeks | measured at week 1 and 8 at fasting and for 5 hours postprandially | NEFA (mEq/dL) response to saturated fatty acid meal |
| change in Fat oxidation over 8 weeks | measured at week 1 and 8 at fasting and for 3.5 hours postprandially | measured (g/hr) via indirect calorimetry |
| change in Carbohydrate oxidation over 8 weeks | measured at week 1 and 8 at fasting and for 3.5 hours postprandially | measured (g/hr) via indirect calorimetry |
| change in Resting metabolic rate (RMR) over 8 weeks | measured at week 1 and 8 at fasting and for 3.5 hours postprandially | RMR (kcals/d) measured via indirect calorimetry |
| change in Respiratory exchange ratio (RER) over 8 weeks | measured at week 1 and 8 at fasting and for 3.5 hours postprandially | measured (VCO2/Vo2) via indirect calorimetry |
| change in subjective appetite over 8 weeks | 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. |
| change in blood triglyceride meal responses over 8 weeks | measured at week 1 and 8 at fasting and for 5 hours postprandially | Triglyceride (mg/dL) response to saturated fatty acid meal |
| Change in Baseline Blood Concentration of Hunger and Satiety Hormones over 8 weeks | 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) |
| Change in Height over 8 weeks | measured at weeks 1, 4, and 8 at fasting | Height measured in centimetres |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Stress over 8 weeks | 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. |
Countries
United States
Outcome results
None listed