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RECRUITING

NCT05686954

Cottonseed Oil Dose Response

Sponsor: University of Georgia

View on ClinicalTrials.gov

Summary

Adding cottonseed oil to the diet has been shown to improve cholesterol profiles and other markers of chronic disease risk in both healthy and at-risk adults. However, CSO has only been tested in the context of high-fat diets. The goal of this clinical trial is to learn about the health effects of lower amounts of cottonseed oil (CSO) added to the diet in adults at increased risk for cardiovascular disease. The main questions it aims to answer are: * How do different amounts of CSO in the diet affect fasting cholesterol profiles and markers of liver function? * How do different amounts of CSO in the diet affect fasting and post-meal markers of lipid metabolism (i.e. triglycerides) and glycemic control (i.e. blood sugar and insulin)? * How do different amounts of CSO in the diet affect fasting and post-meal markers of chronic disease risk factors such as oxidative stress, inflammation, coagulation potential, and appetite control? Participants will be asked to: * Consume provided breakfast shakes and snacks 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 (5.5 h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast. Researchers will compare CSO LOW, CSO MID, CSO HIGH, and Control groups (receiving a mixture of oils) to see if lower doses of CSO in the diet impart the same health benefits as previously shown with high doses of CSO.

Official title: Nutritional Effects of Different Doses of Cottonseed Oil in Humans

Key Details

Gender

All

Age Range

25 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-03-01

Completion Date

2027-05

Last Updated

2024-05-08

Healthy Volunteers

Yes

Conditions

Dyslipidemias Overweight and Obesity Nutrition, Healthy

Interventions

OTHER

CSO LOW

Participants are provided a breakfast shake and a snack daily that delivers 10% of the participant's estimated energy needs as cottonseed oil for 28 days.

OTHER

CSO MID

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

OTHER

CSO HIGH

Participants are provided a breakfast shake and a snack daily that delivers 30% of the participant's estimated energy needs as cottonseed oil for 28 days.

OTHER

CONTROL

Participants are provided a breakfast shake and a snack daily that delivers 10% of the participant's estimated energy needs as a mixture of oils that match the average American fat intake for 28 days.

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 or 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 (overweight 25-29.9 kg/m2 or obesity 30 kg/m2 or greater). 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 for less than 2 years * women who are pregnant * individuals who regularly exercise more than 3 h/w * weight gain or loss of more than 5% of their 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 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, 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/d for men; greater than 2 drinks/d for women) * tobacco or nicotine use * underweight BMI (\<18.5 kg/m2)

Locations (1)

University of Georgia

Athens, Georgia, United States

Clinical Research Directory

Cottonseed Oil Dose Response

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)