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Cottonseed Oil Versus Matched PUFA Effects

Health Effects of Cottonseed Oil Versus Matched Composition Diets in Humans

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 75 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits, 6 visits
  • Procedures mentioned: Blood draws, X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be asked to: * Consume provided meal replacement shakes daily for 28-days. * Attend three weekly short visits for fasting blood draws, body measurements, and collect the next week of study materials, * Attend two longer (5.5h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast."
  • "There are a total of 6 testing visits: screening (v0), pre-intervention (v1), 3 weekly short visits (v2, v3, v4), and post-intervention (v5)."
  • "At screening (v0), qualification is confirmed based on anthropometrics and fasting blood draw, which is analyzed for a cholesterol panel and blood glucose."
  • "At v1, participants will have anthropometrics measured, including body composition by dual-energy x-ray absorptiometry (DXA)."
  • "Fasting and postprandial blood draws for a 5h period will occur following a high saturated-fat meal challenge which delivers 35% of the participant's estimated energy needs. 28-day dietary intervention: Participants will consume a daily shake corresponding to the participant's randomly assigned group."
  • "At these weekly visits, participants also have a fasting blood draw, body measures, and consume the daily breakfast shake in the lab."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether cottonseed oil improves cholesterol, blood fats, and other signs of long-term disease risk compared with similar oil blends. It is for adults ages 25–75 with higher cholesterol or excess body weight. Participants drink study shakes daily for 28 days and attend visits for blood tests and body measurements.

Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. Cottonseed oil (CSO) is found readily in the food supply, and the investigator's previous studies have demonstrated that incorporating CSO into the diet is sufficient to improve fasting cholesterol profile and improve postprandial lipid and/or glycemic responses in both healthy, and at-risk populations. This study aims to compare CSO to a fatty acid composition-matched diet, on changes in fasting and postprandial lipid metabolism and markers of chronic disease risk. The specific aims are: * Examine the impact of CSO vs. PUFA on fasting and postprandial lipids. * Examine the impact of CSO on other markers of chronic disease risk. Participants will be asked to: * Consume provided meal replacement shakes daily for 28-days. * Attend three weekly short visits for fasting blood draws, body measurements, and collect the next week of study materials, * Attend two longer (5.5h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast. Researchers will compare CSO vs. PUFA and control groups (receiving a mixture of oils) to see if CSO is unique in imparting health benefits when compared with similar matched oil diets.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men and women ages 25–75 with higher cholesterol levels or a body mass index (BMI) above 25. BMI is a measure of weight compared with height.
  • To qualify based on cholesterol, have at least two of these levels: total cholesterol 180–239 mg/dL, LDL (“bad” cholesterol) 110–159 mg/dL, or triglycerides (blood fats) 130–199 mg/dL.
  • You can also qualify with any one of these levels: total cholesterol at least 240 mg/dL, LDL at least 160 mg/dL, or triglycerides 200–350 mg/dL.

Who can't join

  • Likely inherited high cholesterol: total cholesterol above 290 mg/dL or LDL above 190 mg/dL, plus a family history of heart attack before age 60 in a parent, sibling, or child, or before age 50 in a grandparent, aunt, uncle, or other second-degree relative.
  • Pregnant, or a woman who has used hormone replacement therapy for less than 2 years.
  • Exercise more than 3 hours a week; gained or lost more than 5% of body weight in the past 3 months; plan to start a weight-loss or exercise program during the study; or have a BMI below 18.5.
  • Past medical problems or surgery affecting swallowing or digestion, or any surgery or disorder of the stomach or intestines.
  • Any long-term disease, including moderate to severe asthma, long-term lung disease, kidney disease, cancer, disease affecting how the body uses food, or plaque buildup in arteries; or a past heart attack or stroke.
  • Blood sugar after fasting above 126 mg/dL, or blood pressure above 180/120 mmHg.
  • Use medicines that affect digestion, nutrient absorption, or how the body uses food, including thyroid medicines; cholesterol-lowering or diabetes medicines; steroid or hormone treatments; current antibiotics; or fish oil supplements.
  • Follow a prescribed or special diet; have allergies to study foods, including wheat, dairy, or cottonseed oil; use tobacco or nicotine; or drink more than 3 alcoholic drinks daily for men or 2 for women.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 25-75 year-old men and women at increased risk for cardiovascular disease. Increased risk for cardiovascular disease will be defined by either elevated cholesterol profiles -or- overweight/obesity. * Elevated cholesterol profiles will be defined as: -"Borderline High" and/or "at risk" in two of more of the following variables (total cholesterol: 180-239 mg/dL, LDL cholesterol 110-159 mg/dL, triglycerides 130-199 mg/dL) --or-- * "High" in total cholesterol (240 mg/dL and higher), LDL (160 mg/dL or higher), or triglycerides (between 200-350 mg/dL). Overweight/obesity will be defined by body mass index \>25 kg/m². Exclusion Criteria: * Probable familial hypercholesterolemia, defined by: total cholesterol greater than 290 mg/dL or LDL levels greater than 190 mg/dL plus a family history of myocardial infarction (MI) before 50 years of age in a 2nd-degree relative or below age 60 in a 1st-degree relative. * Women on hormone replacement therapy less than 2 years. * Women who are pregnant * individuals who regularly exercise more than 3h/w * weight gain or loss of more than 5% body weight in the past 3 months * plans to begin a weight loss/exercise regimen during the trial * history of medical or surgical events that could affect digestion or swallowing * gastrointestinal surgeries, conditions, or disorders * any chronic diseases (including moderate to severe asthma, chronic lung disease, and kidney disease), * metabolic disease * 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 an absorption, metabolism (e.g. thyroid meds), lipid-lowering medications, medications for diabetes, steroid/hormone therapies, or current antibiotic cycles * medically prescribed or special diets * Food allergies (specific to the foods in the study, including wheat, dairy, and cottonseed oil) * fish oil supplements * excessive alcohol use (greater than 3 drinks/day for men; greater than 2 drinks/day for women) * tobacco or nicotine use * underweight BMI (\<18.5 kg/m²)

Study sites (1)

GA