HypercholesterolemiaNCT04397055
Oil Consumption and Cholesterol
A study testing Cottonseed Oil and Olive Oil in people with Hypercholesterolemia, run by University of Georgia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Cottonseed Oil and Olive Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2018to 8 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Blood Lipids From Diets Enriched With Cottonseed Oil Versus Olive Oil in Adults With High Cholesterol
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.
Read the 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.
- Conditions
- Hypercholesterolemia
- Being tested
- Cottonseed Oil, Olive Oil
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cottonseed OilDietary supplement
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 OilDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Cottonseed Oil | Experimental | Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance Receives: Dietary Supplement: Cottonseed Oil |
| Olive Oil | Active comparator | Participants are given foods enriched with olive oil and instructed on how to substitute study foods into their diet to maintain caloric balance Receives: Dietary Supplement: Olive Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: Baseline, 4 weeks, 8 weeks
Change in baseline low density lipoprotien (LDL) peak size at weeks 4 and 8
LDL peak size (angstrom)
Measured: Baseline, 4 weeks, 8 weeks
Secondary outcomes (16)
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: measured at weeks 1 and 8 at fasting and for 5 hours postprandially
Change in Height over 8 weeks
Height measured in centimetres
Measured: measured at weeks 1, 4, and 8 at fasting
Change in weight over 8 weeks
weight measured in pounds and kilograms
Measured: 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: measured at weeks 1, 4, and 8 at fasting
change in waist circumference over 8 weeks
waist circumference measured in centimetres
Measured: measured at weeks 1, 4, and 8 at fasting
change in hip circumference over 8 weeks
hip circumference measured in centimetres
Measured: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start14 May 2018
- Primary completion8 Jun 2021
- Study completion8 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 8 week parallel feeding trials of diets rich in Cottonseed oil or Olive Oil
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cottonseed Products Association, Cotton Incorporated, University of Georgia Obesity Initiative
- Responsible party
- Principal investigator, Jamie Cooper, PhD, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397055
- Sponsor's protocol ID
- STUDY00005869
- Status last verified
- May 2023
- First submitted
- 30 Apr 2020
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is to share group averages through publication
Publications
Prater MC, Scheurell AR, Paton CM, Cooper JA. Eight weeks of daily cottonseed oil intake attenuates postprandial angiopoietin-like proteins 3 and 4 responses compared to olive oil in adults with hypercholesterolemia: A secondary analysis of a randomized clinical trial. Nutr Res. 2024 Mar;123:88-100. doi: 10.1016/j.nutres.2024.01.006. Epub 2024 Jan 12.
PubMed 38295507Prater MC, Scheurell AR, Paton CM, Cooper JA. Hunger and satiety responses to diets enriched with cottonseed oil vs. olive oil. Physiol Behav. 2023 Feb 1;259:114041. doi: 10.1016/j.physbeh.2022.114041. Epub 2022 Nov 24.
PubMed 36427543Prater MC, Scheurell AR, Paton CM, Cooper JA. Metabolic responses to 8 weeks of consuming cottonseed oil versus olive oil in adults with dyslipidaemia: a randomised trial. J Hum Nutr Diet. 2023 Jun;36(3):1079-1089. doi: 10.1111/jhn.13085. Epub 2022 Sep 16.
PubMed 36056703Prater MC, Scheurell AR, Paton CM, Cooper JA. Blood Lipid Responses to Diets Enriched with Cottonseed Oil Compared With Olive Oil in Adults with High Cholesterol in a Randomized Trial. J Nutr. 2022 Sep 6;152(9):2060-2071. doi: 10.1093/jn/nxac099.
PubMed 35511204
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blood Lipids From Diets Enriched With Cottonseed Oil Versus Olive Oil in Adults With High Cholesterol
- ClinicalTrials.gov ID
- NCT04397055
- Acronym / sponsor ID
- STUDY00005869
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- National Cottonseed Products Association, Cotton Incorporated, University of Georgia Obesity Initiative
- Study start
- 14 May 2018 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 8 week parallel feeding trials of diets rich in Cottonseed oil or Olive Oil
| Arm | Type | Receives |
|---|---|---|
| Cottonseed Oil | Experimental | Dietary Supplement: Cottonseed OilParticipants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance |
| Olive Oil | Active comparator | Dietary Supplement: Olive OilParticipants are given foods enriched with olive oil and instructed on how to substitute study foods into their diet to maintain caloric balance |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cottonseed OilParticipants 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 supplement | Cottonseed Oil |
| Olive OilParticipants 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 | Dietary supplement | Olive Oil |
Primary outcome
Change in baseline fasting blood lipids at weeks 4 and 8
Time frame: 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
Time frame: 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 low density lipoprotien (LDL) peak size at weeks 4 and 8
Time frame: Baseline, 4 weeks, 8 weeks
LDL peak size (angstrom)
16 secondary outcomes
Change in Baseline Blood Concentration of Hunger and Satiety Hormones over 8 weeks
Time frame: measured at weeks 1 and 8 at fasting and for 5 hours postprandially
Change in Height over 8 weeks
Time frame: measured at weeks 1, 4, and 8 at fasting
Change in weight over 8 weeks
Time frame: measured at weeks 1, 4, and 8 at fasting
change in blood pressure over 8 weeks
Time frame: measured at weeks 1, 4, and 8 at fasting
change in waist circumference over 8 weeks
Time frame: measured at weeks 1, 4, and 8 at fasting
change in hip circumference over 8 weeks
Time frame: measured at weeks 1, 4, and 8 at fasting
change in total body fat percentage over 8 weeks
Time frame: measured at weeks 1, 4, and 8 at fasting
change in Blood glucose concentration responses (glycemia) over 8 weeks
Time frame: measured at week 1 and 8 at fasting and for 5 hours postprandially
change in Blood insulin concentration responses (glycemia) over 8 weeks
Time frame: measured at week 1 and 8 at fasting and for 5 hours postprandially
change in blood triglyceride meal responses over 8 weeks
Time frame: 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
Time frame: measured at week 1 and 8 at fasting and for 5 hours postprandially
change in Fat oxidation over 8 weeks
Time frame: measured at week 1 and 8 at fasting and for 3.5 hours postprandially
change in Carbohydrate oxidation over 8 weeks
Time frame: measured at week 1 and 8 at fasting and for 3.5 hours postprandially
change in Resting metabolic rate (RMR) over 8 weeks
Time frame: measured at week 1 and 8 at fasting and for 3.5 hours postprandially
change in Respiratory exchange ratio (RER) over 8 weeks
Time frame: measured at week 1 and 8 at fasting and for 3.5 hours postprandially
change in subjective appetite over 8 weeks
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 38295507Prater MC, Scheurell AR, Paton CM, Cooper JA. Eight weeks of daily cottonseed oil intake attenuates postprandial angiopoietin-like proteins 3 and 4 responses compared to olive oil in adults with hypercholesterolemia: A secondary analysis of a randomized clinical trial. Nutr Res. 2024 Mar;123:88-100. doi: 10.1016/j.nutres.2024.01.006. Epub 2024 Jan 12.
- Derived from this study: PubMed 36427543Prater MC, Scheurell AR, Paton CM, Cooper JA. Hunger and satiety responses to diets enriched with cottonseed oil vs. olive oil. Physiol Behav. 2023 Feb 1;259:114041. doi: 10.1016/j.physbeh.2022.114041. Epub 2022 Nov 24.
- Derived from this study: PubMed 36056703Prater MC, Scheurell AR, Paton CM, Cooper JA. Metabolic responses to 8 weeks of consuming cottonseed oil versus olive oil in adults with dyslipidaemia: a randomised trial. J Hum Nutr Diet. 2023 Jun;36(3):1079-1089. doi: 10.1111/jhn.13085. Epub 2022 Sep 16.
- Derived from this study: PubMed 35511204Prater MC, Scheurell AR, Paton CM, Cooper JA. Blood Lipid Responses to Diets Enriched with Cottonseed Oil Compared With Olive Oil in Adults with High Cholesterol in a Randomized Trial. J Nutr. 2022 Sep 6;152(9):2060-2071. doi: 10.1093/jn/nxac099.
- Individual participant dataSharing planned: No. The plan is to share group averages through publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cottonseed Oil and Olive Oil in people with Hypercholesterolemia, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline fasting blood lipids at weeks 4 and 8 (time frame: Baseline, 4 weeks, 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04397055, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.