Nutritional Effects of Different Doses of Cottonseed Oil in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Change in fasting serum lipoprotein and cholesterol concentrations
研究概览
简要总结
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.
详细描述
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 our food supply. Our previous studies have demonstrated that incorporating CSO into the diet is sufficient to reduce fasting total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-c), increase high-density lipoprotein cholesterol (HDL-c), and improve postprandial lipid and/or glycemic responses in both healthy and at-risk populations. However, in these human studies, diets provided 30-44% of total energy from CSO, which corresponded to high-fat (HF) diet intake (40-50% of energy). The impact of lower doses of CSO on human health has yet to be tested. Therefore, this study aims to investigate whether lower doses of CSO are equally effective as previously proven high doses for improving fasting and postprandial lipid metabolism and markers of chronic disease risk. If lower doses of CSO in the diet are found to improve these markers, these study findings could lead to improvements in health.
This prospective clinical study is a single-blinded, randomized control trial in adults at increased risk for cardiovascular disease (poor cholesterol profiles or overweight/obesity). There are four diet interventions: CSO LOW (10% energy from CSO), CSO MID (20% energy from CSO), CSO HIGH (30% energy from CSO), and CON (10% energy from control oil mix). The study protocol consists of a 28-day intervention where participants are provided breakfast shakes and snacks that contain different amounts of cooking oil depending on their random group assignment.
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. Additionally, energy requirements are estimated at this visit for use in the diet intervention.
At v1, participants will have anthropometrics measured, including body composition, by BodPod. Next, a certified phlebotomist places an IV catheter and takes the fasting blood sample. Then the participant consumes a high-saturated-fat meal challenge which delivers 35% of their estimated energy needs (from v0). Then the participant has blood drawn 8 times using the IV catheter over the next 5 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants are blinded to which group they are in and what oil they are receiving.
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
- •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)
研究组 & 干预措施
CSO LOW
Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance.
干预措施: CSO LOW (Other)
CSO MID
Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance.
干预措施: CSO MID (Other)
CSO HIGH
Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance.
干预措施: CSO HIGH (Other)
CONTROL
Participants are given foods enriched with a mixture of oils and instructed on how to substitute study foods into their diet to maintain caloric balance.
干预措施: CONTROL (Other)
结局指标
主要结局
Change in fasting serum lipoprotein and cholesterol concentrations
时间窗: baseline, 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 non-esterified fatty acid (NEFA) concentrations
时间窗: baseline, 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 concentrations
时间窗: baseline, 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 plasma markers of coagulation potential
时间窗: baseline, 4 weeks
The concentration of plasminogen activator inhibitor-1, and tissue factor before and after the high saturated fat meal challenge at both pre- and post-intervention visits (pg/mL).
Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins
时间窗: baseline, 4 weeks
The concentration of ANGPTL 3, ANGPTL 4, and ANGPTL 8 before and after the high saturated fat meal challenge at both pre- and post-intervention visits (ng/mL).
Change in fasting serum lipoprotein particle numbers
时间窗: baseline, 4 weeks
Number of particles of low density lipoproteins (LDL), LDL small, HDL large, LDL medium, lipoprotein (a) (nmol/L)
Change in fasting and postprandial subjective feelings related to appetite
时间窗: baseline, 4 weeks
Visual analog scale ratings of feelings related to appetite before and after the high saturated fat meal challenge 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)
时间窗: 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 inflammatory cytokine concentrations
时间窗: baseline, 4 weeks
The concentration of interleukin-1 beta, C reactive protein, tumor-necrosis factor-alpha, and interleukin-6 before and after the high saturated fat meal challenge at both pre- and post-intervention visits (pg/mL).
Change in fasting and postprandial plasma triglyceride concentrations
时间窗: baseline, 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 total antioxidant capacity
时间窗: baseline, 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 and postprandial plasma insulin concentrations
时间窗: baseline, 4 weeks
The concentration of plasma insulin before and after the high saturated fat meal challenge at both pre- and post-intervention visits (uU/mL)
Change in fasting insulin resistance metrics
时间窗: baseline, 4 weeks
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment for β-cell function (HOMA-B) will be calculated from fasting insulin and glucose measures before and after the 28-day intervention.
Change in fasting and postprandial plasma glucose concentrations
时间窗: baseline, 4 weeks
The concentration of plasma glucose before and after the high saturated fat meal challenge at both pre- and post-intervention visits (mg/dL)
次要结局
- Change in fasting serum hepatic proteins(Baseline, 4 weeks)
- Change in fasting serum hepatic enzymes(Baseline, 4 weeks)
- Change in additional fasting and postprandial plasma inflammatory cytokine concentrations(baseline, 4 weeks)
- Change in additional fasting and postprandial plasma markers of coagulation potential(baseline, 4 weeks)
- Change in acute dietary intake(baseline, 4 weeks)
- Change in fasting serum bilirubin(Baseline, 4 weeks)
- Change in additional fasting and postprandial plasma appetite control hormones concentrations(baseline, 4 weeks)
- Change in fasting and postprandial plasma antioxidant parameters(baseline, 4 weeks)
研究者
Jamie Cooper, PhD
Professor, Director of UGA Obesity Initiative
University of Georgia