Oil Consumption and Cholesterol

NCT04397055 | Completed

• 1 other identifier: STUDY00005869
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

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

  LDL peak size (angstrom)

  Baseline, 4 weeks, 8 weeks

Secondary Outcomes (16)

• 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

• Change in Height over 8 weeks

  measured at weeks 1, 4, and 8 at fasting

• Change in weight over 8 weeks

  measured at weeks 1, 4, and 8 at fasting

• change in blood pressure over 8 weeks

  measured at weeks 1, 4, and 8 at fasting

• change in waist circumference over 8 weeks

  measured at weeks 1, 4, and 8 at fasting

Other Outcomes (1)

• Change in Perceived Stress over 8 weeks

  measured at week 1, 4, and 8 at fasting

Study Arms (2)

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

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

Dietary Supplement: Olive Oil

Interventions

Cottonseed Oil DIETARY_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

Cottonseed Oil

Olive Oil DIETARY_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

Olive Oil

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Georgia: lead
• National Cottonseed Products Association: collaborator
• Cotton Incorporated: collaborator
• University of Georgia Obesity Initiative: collaborator

Study Sites (1)

University of Georgia

Athens, Georgia, 30605, United States

Location

Related Publications (4)

• 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.

  PMID: 38295507 DERIVED

• Prater 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.

  PMID: 36427543 DERIVED

• Prater 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.

  PMID: 36056703 DERIVED

• Prater 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.

  PMID: 35511204 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Cottonseed Oil; Olive Oil

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to which oil they are receiving
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Dept. of Foods and Nutrition

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

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 21, 2020
• Study Start: May 14, 2018
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)