Clinical trial

Cottonseed Oil Versus Matched PUFA Effects

Recruiting now · Not applicable · 1 countries · Registry ID NCT06382298

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 75 Years

SexAll

Healthy volunteersAccepted

ConditionDyslipidemia, Overweight and Obesity, Nutrition, Healthy

Full registry 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)

Treatments and study arms

COTTONSEED OIL

Other

Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs as cottonseed oil for 28 days.

MATCHED PUFA DIET

Other

Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs from oils with similar fatty acid composition as CSO for 28 days.

CONTROL

Other

Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs as a mixture of oils that match the average American fat intake for 28 days.

Primary outcomes

Change in fasting serum lipoprotein and cholesterol concentrationsbaseline, 4 weeks

The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein B (mg/dL)

Change in fasting and postprandial plasma triglyceride concentrationsbaseline, 4 weeks

The concentration of plasma triglycerides before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mg/dL)

Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrationsbaseline, 4 weeks

The concentration of plasma NEFAs before and after the high saturated fat meal challenge at both pre- and post- intervention visits (mEq/L)

Change in fasting and postprandial plasma appetite control hormones concentrationsbaseline, 4 weeks

The concentration of plasma appetite control hormones before and after the high saturated fat meal challenge at both pre- and post-intervention visits. Appetite control hormones include cholecystokinin (CCK), Peptide YY (PYY), Ghrelin (pg/mL)

Change in fasting and postprandial subjective feelings related to appetitebaseline, 4 weeks

Visual analog scale ratings of feelings related to appetite before and after the high saturated fat meal challenge, and for the remainder of the day, at both pre- and post- intervention visits. Subjective feelings of hunger, fullness, desire to eat, prospective consumption and a composite appetite score are measured by visual analog scales (mm).

Change in fasting and postprandial plasma Malondialdehyde (MDA)baseline, 4 weeks

The concentration of MDA before and after the high saturated fat meal challenge at both pre- and post- intervention visits (nmol/mL).

Change in fasting and postprandial plasma total antioxidant capacitybaseline, 4 weeks

Total antioxidant capacity before and after the high saturated fat meal challenge at both pre- and post- intervention visits (U/mL).

Change in fasting inflammatory cytokine concentrationsbaseline, 4 weeks

The concentration of interleukin-1 beta, C reactive protein, tumor-necrosis factor-alpha, and interleukin-6 at fasting at both pre-and post-intervention visits (pg/mL).

Study locations

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University of Georgia🇺🇸 Athens, Georgia, United States

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Jamie A Cooper, Ph.D.Contact

Email · Call 706-542-4378

Jamie A Cooper, Ph.D.Principal Investigator