Oil Consumption and Cholesterol

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04397055
• Other study ID #: STUDY00005869
• Status: Completed
• Phase: N/A
• Start date: May 14, 2018
• Est. completion date: June 8, 2021

Study information

• Verified date: May 2023
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 8, 2021
• Est. primary completion date: June 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Cottonseed 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
• Olive 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

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia

Sponsors (4)

Lead Sponsor	Collaborator
University of Georgia	Cotton Incorporated, National Cottonseed Products Association, University of Georgia Obesity Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Perceived Stress over 8 weeks	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
Primary	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
Primary	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
Primary	Change in baseline low density lipoprotien (LDL) peak size at weeks 4 and 8	LDL peak size (angstrom)	Baseline, 4 weeks, 8 weeks
Secondary	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
Secondary	Change in Height over 8 weeks	Height measured in centimetres	measured at weeks 1, 4, and 8 at fasting
Secondary	Change in weight over 8 weeks	weight measured in pounds and kilograms	measured at weeks 1, 4, and 8 at fasting
Secondary	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
Secondary	change in waist circumference over 8 weeks	waist circumference measured in centimetres	measured at weeks 1, 4, and 8 at fasting
Secondary	change in hip circumference over 8 weeks	hip circumference measured in centimetres	measured at weeks 1, 4, and 8 at fasting
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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