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Oil Consumption and Cholesterol

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cottonseed Oil

Olive Oil

About this trial

This is an interventional prevention trial for Hypercholesterolemia

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Georgia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cottonseed Oil

Olive Oil

Arm Description

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 given foods enriched with olive oil and instructed on how to substitute study foods into their diet to maintain caloric balance

Outcomes

Primary Outcome Measures

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)

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).

Change in baseline low density lipoprotien (LDL) peak size at weeks 4 and 8

LDL peak size (angstrom)

Secondary Outcome Measures

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)

Change in Height over 8 weeks

Height measured in centimetres

Change in weight over 8 weeks

weight measured in pounds and kilograms

change in blood pressure over 8 weeks

both systolic and diastolic blood pressure measured in millimetres of mercury (mmHg)

change in waist circumference over 8 weeks

waist circumference measured in centimetres

change in hip circumference over 8 weeks

hip circumference measured in centimetres

change in total body fat percentage over 8 weeks

total body fat percentage measured as percent of total body mass

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

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

change in blood triglyceride meal responses over 8 weeks

Triglyceride (mg/dL) response to saturated fatty acid meal

change in non-esterified free fatty acid (NEFA) meal responses over 8 weeks

NEFA (mEq/dL) response to saturated fatty acid meal

change in Fat oxidation over 8 weeks

measured (g/hr) via indirect calorimetry

change in Carbohydrate oxidation over 8 weeks

measured (g/hr) via indirect calorimetry

change in Resting metabolic rate (RMR) over 8 weeks

RMR (kcals/d) measured via indirect calorimetry

change in Respiratory exchange ratio (RER) over 8 weeks

measured (VCO2/Vo2) via indirect calorimetry

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.

Full Information

NCT ID

NCT04397055

First Posted

April 30, 2020

Last Updated

May 8, 2023

Sponsor

University of Georgia

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04397055

Brief Title

Oil Consumption and Cholesterol

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

May 14, 2018 (Actual)

Primary Completion Date

June 8, 2021 (Actual)

Study Completion Date

June 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Georgia

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

8 week parallel feeding trials of diets rich in Cottonseed oil or Olive Oil

Masking

Participant

Masking Description

Participants are blinded to which oil they are receiving

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cottonseed Oil

Arm Type

Experimental

Arm Description

Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance

Arm Title

Olive Oil

Arm Type

Active Comparator

Arm Description

Participants are given foods enriched with olive oil and instructed on how to substitute study foods into their diet to maintain caloric balance

Intervention Type

Dietary Supplement

Intervention Name(s)

Cottonseed Oil

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Olive Oil

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in baseline fasting blood lipids at weeks 4 and 8

Description

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)

Time Frame

Baseline, 4 weeks, 8 weeks

Title

Change in baseline lipoprotein (a), lipoprotien particle number and size at weeks 4 and 8

Description

Low density lipoprotien (LDL) particle number (nmol/L), LDL small (nmol/L), HDL large (nmol/L), LDL medium (nmol/L), lipoprotein (a) (nmol/L).

Time Frame

Baseline, 4 weeks, 8 weeks

Title

Change in baseline low density lipoprotien (LDL) peak size at weeks 4 and 8

Description

LDL peak size (angstrom)

Time Frame

Baseline, 4 weeks, 8 weeks

Secondary Outcome Measure Information:

Title

Change in Baseline Blood Concentration of Hunger and Satiety Hormones over 8 weeks

Description

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)

Time Frame

measured at weeks 1 and 8 at fasting and for 5 hours postprandially

Title

Change in Height over 8 weeks

Description

Height measured in centimetres

Time Frame