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| Name | Class |
|---|---|
| National Cottonseed Products Association | UNKNOWN |
| Cotton Incorporated | UNKNOWN |
| University of Georgia Obesity Initiative | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia | Athens | Georgia | 30605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38295507 | Derived | 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. | |
| 36427543 |
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The plan is to share group averages through publication
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D003369 | Cottonseed Oil |
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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8 week parallel feeding trials of diets rich in Cottonseed oil or Olive Oil
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Participants are blinded to which oil they are receiving
| 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 |
|
| Change in Height over 8 weeks |
Height measured in centimetres |
| measured at weeks 1, 4, and 8 at fasting |
| Change in weight over 8 weeks | weight measured in pounds and kilograms | 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 at weeks 1, 4, and 8 at fasting |
| change in waist circumference over 8 weeks | waist circumference measured in centimetres | measured at weeks 1, 4, and 8 at fasting |
| change in hip circumference over 8 weeks | hip circumference measured in centimetres | 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 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 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 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 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 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 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 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 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 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 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 |
| measured at week 1, 4, and 8 at fasting |
| 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. |
| 36056703 | 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. |
| 35511204 | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |