Oil Consumption and Cholesterol
- Conditions
- Hypercholesterolemia
- Interventions
- Dietary Supplement: Olive OilDietary Supplement: Cottonseed Oil
- Registration Number
- NCT04397055
- Lead Sponsor
- University of Georgia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olive Oil 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 Cottonseed Oil 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
- Primary Outcome Measures
Name Time Method 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).
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 low density lipoprotien (LDL) peak size at weeks 4 and 8 Baseline, 4 weeks, 8 weeks LDL peak size (angstrom)
- Secondary Outcome Measures
Name Time Method 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 Height over 8 weeks measured at weeks 1, 4, and 8 at fasting Height 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 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 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 weight over 8 weeks measured at weeks 1, 4, and 8 at fasting weight measured in pounds and kilograms
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 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 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 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 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
Trial Locations
- Locations (1)
University of Georgia
🇺🇸Athens, Georgia, United States