The Effects of Orange Juice Compared With Sugar-sweetened Beverage on Risk Factors and Metabolic Processes Associated With the Development of Cardiovascular Disease and Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Postprandial Uric Acid
研究概览
简要总结
The objectives of this proposal are to address the gaps in knowledge regarding the metabolic effects of consuming orange juice, the most frequently consumed fruit juice in this country, compared to sugar-sweetened beverage.
详细描述
Specific Aims: There is considerable epidemiological evidence that demonstrates associations between added sugar/sugar-sweetened beverage consumption and increased risk for or prevalence of chronic diseases such as cardiovascular disease (CVD), type 2 diabetes (T2D), metabolic syndrome, and gout. Especially concerning is recent evidence from National Health and Nutrition Examination Survey III that demonstrates that there is increased risk of CVD mortality with increased intake of added sugar across quintiles (Yang, 2014). Even the US mean added sugar intake, 15% of daily calories, was associated with an 18% increase in risk of CVD mortality over 15 years. The results from the investigator's recently completed study (1R01 HL09133) corroborate these findings (Stanhope, 2015). They demonstrate that supplementing the ad libitum diets of young adults with beverages containing 0, 10, 17.5 or 25% of daily energy requirement (Ereq) as high fructose corn syrup (HFCS) affects lipid/lipoprotein risk factors for CVD in a dose response manner. Specifically, levels of nonHDL-cholesterol(C), LDL-C, apolipoprotein B (apoB), and postprandial triglycerides (TG) increased linearly over a 2-week period with increasing doses of HFCS. Furthermore, even the participants consuming the 10% Ereq dose exhibited increased levels of these risk factors compared to baseline.
These and similar results have helped to lead to reductions in soda consumption in this country, and new dietary guidelines and FDA food labeling requirements to promote reductions in added sugar consumption. However, there are gaps in knowledge about other sugar-containing foods that lead to public confusion concerning healthier options for soda, and impede further progress in implementing public health policies that will promote further reductions in soda consumption. One such food is naturally-sweetened fruit juice. The amount of sugar in fruit juice is comparable to the amount in soda. Because of this, a consumer seeking answers on the internet will find many articles in which experts state or suggest that the effects of consuming fruit juice are as detrimental as or even worse than those of soda. However, in contrast to soda, fruit juice contains micronutrients and bioactives that may promote health. Therefore the consumer can also find numerous articles on the internet where the health benefits of fruit juice and these bioactives are extolled. There are a limited number of clinical dietary intervention studies that have directly compared the metabolic effects of consuming fruit juice and sugar-sweetened beverage, and their results are not conclusive. Thus we will pursue the following Specific Aims:
- Specific Aim 1: To compare the weight-independent effects of consuming 25%Ereq as orange juice or sugar-sweetened beverages for 4 weeks on risk factors for CVD and other chronic disease in normal weight and overweight men and women.
- Specific Aim 2: To mechanistically compare the weight-independent effects of consuming 25%Ereq as orange juice or sugar-sweetened beverages on metabolic processes associated with the development of CVD and T2D in normal weight and overweight men and women.
- Specific Aim 3: To relate the changes assessed under Specific Aims 1 and 2 to the changes in the urinary levels of metabolites and catabolites of the main flavanones in orange juice, hesperetin and naringenin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
All outcomes will be analyzed/assessed by subject identity number, which are assigned prior to randomization to experimental arm.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and pre-menopausal women Body mass index: 20-35 kg/m2 Body weight > than 50 kg Self-reported stable body weight during the prior six months
排除标准
- •Fasting glucose >125 mg/dl Evidence of liver disorder (AST or ALT >200% upper limit of normal range) Evidence of kidney disorder (>2.0 mg/dl creatinine) Evidence of thyroid disorder (out of normal range) Systolic blood pressure consistently over 140 mmHg or diastolic blood pressure over 90 mmHg Triglycerides > 400 mg/dl LDL-C > 160 mg/dl in combination with Chol:HDL > 4 Hemoglobin < 10 g/dL Pregnant or lactating women Current, prior (within 12 months), or anticipated use of any hypolipidemic or anti-diabetic agents.
- •Use of thyroid, anti-hypertensive, anti-depressant, weight loss medications or any other medication which, in the opinion of the investigator, may confound study results Use of tobacco Strenuous exerciser (>3.5 hours/week at a level more vigorous than walking) Surgery for weight loss Diet exclusions: Food allergies, special dietary restrictions, routine consumption of less than 3 meals/day, routine ingestion of more than 2 sugar-sweetened beverages or 1 alcoholic beverage/day, unwillingness to consume any food on study menu Veins that are assessed by the R.N.s as being unsuitable for long-term infusions and multiple blood draws from a catheter.
- •Pre-existing claustrophobia or metal implants that preclude magnetic resonance imaging Any other condition that, in the opinion of the investigators, would put the subject at risk
结局指标
主要结局
Postprandial Uric Acid
时间窗: 4 weeks
Absolute change of post-dinner 4-hour AUC plasma uric acid concentration (4 week value - 0 week value)
Fasting Apolipoprotein CIII (apoCIII)
时间窗: 4 weeks
Absolute change of fasting plasma apoCIII concentration (4 week value - 0 week value)
Postprandial Apolipoprotein CIII (apoCIII)
时间窗: 4 weeks
Absolute change of plasma postprandial apoCIII concentration (4 week value - 0 week value)
Postprandial Triglyceride
时间窗: 4 weeks
Absolute change of 4-h post-dinner AUC plasma triglyceride concentration (4 week value - 0 week value)
Hepatic Triglyceride
时间窗: 4 weeks
Absolute change of % hepatic triglyceride (4 week value - 0 week value)
Matsuda Insulin Sensitivity Index (ISI)
时间窗: 4 week
Absolute change of Matsuda ISI (4 week value - 0 week value). The Matsuda Index is a ratio of glucose and insulin levels during oral glucose tolerance test. It is calculated using fasting and mean glucose and insulin measurements, but the units of these measurements cancel out in the formula. A Matsuda value less than 2.5 may indicate insulin resistance, thus a lowering of the Matsuda index is a detrimental outcome. At baseline the Matsuda index in the participants for which it was assessed ranged from 1.4 to 7.8 (mean = 3.7, standard deviation = 1.6).
Postprandial de Novo Lipogenesis
时间窗: 4 weeks
Absolute change of 8-hour area under the curve (AUC) percentage fractional rate postprandial de novo lipogenesis DNL (4 week value - 0 week value)
Fasting Low Density Lipoprotein Cholesterol (LDL-C)
时间窗: 4 weeks
Absolute change of plasma LDL-C concentration (4 week value - 0 week value)
Postprandial Low Density Lipoprotein Cholesterol (LDL-C)
时间窗: 4 weeks
Absolute change of plasma postprandial LDL-C concentration (4 week value - 0 week value)
Fasting Apolipoprotein B (apoB)
时间窗: 4 weeks
Absolute change of plasma apoB concentration (4 week value - 0 week value)
Postprandial Apolipoprotein B (apoB)
时间窗: 4 weeks
Absolute change of plasma postprandial apoB concentration (4 week value - 0 week value)
Fasting Uric Acid
时间窗: 4 weeks
Absolute change of plasma uric acid concentration (4 week value - 0 week value)
Fasting Low Density Lipoprotein Cholesterol (LDL-C)
时间窗: 4 weeks
Absolute change of plasma LDL-C concentration (4 week value - 0 week value)
Postprandial Low Density Lipoprotein Cholesterol (LDL-C)
时间窗: 4 weeks
Absolute change of plasma postprandial LDL-C concentration (4 week value - 0 week value)
Fasting Apolipoprotein B (apoB)
时间窗: 4 weeks
Absolute change of plasma apoB concentration (4 week value - 0 week value)
Postprandial Apolipoprotein B (apoB)
时间窗: 4 weeks
Absolute change of plasma postprandial apoB concentration (4 week value - 0 week value)
Fasting Uric Acid
时间窗: 4 weeks
Absolute change of plasma uric acid concentration (4 week value - 0 week value)
Postprandial Uric Acid
时间窗: 4 weeks
Absolute change of post-dinner 4-hour AUC plasma uric acid concentration (4 week value - 0 week value)
Fasting Apolipoprotein CIII (apoCIII)
时间窗: 4 weeks
Absolute change of fasting plasma apoCIII concentration (4 week value - 0 week value)
Postprandial Apolipoprotein CIII (apoCIII)
时间窗: 4 weeks
Absolute change of plasma postprandial apoCIII concentration (4 week value - 0 week value)
Postprandial Triglyceride
时间窗: 4 weeks
Absolute change of 4-h post-dinner AUC plasma triglyceride concentration (4 week value - 0 week value)
Hepatic Triglyceride
时间窗: 4 weeks
Absolute change of % hepatic triglyceride (4 week value - 0 week value)
Matsuda Insulin Sensitivity Index (ISI)
时间窗: 4 week
Absolute change of Matsuda ISI (4 week value - 0 week value). The Matsuda Index is a ratio of glucose and insulin levels during oral glucose tolerance test. It is calculated using fasting and mean glucose and insulin measurements, but the units of these measurements cancel out in the formula. A Matsuda value less than 2.5 may indicate insulin resistance, thus a lowering of the Matsuda index is a detrimental outcome. At baseline the Matsuda index in the participants for which it was assessed ranged from 1.4 to 7.8 (mean = 3.7, standard deviation = 1.6).
Postprandial de Novo Lipogenesis
时间窗: 4 weeks
Absolute change of 8-hour area under the curve (AUC) percentage fractional rate postprandial de novo lipogenesis DNL (4 week value - 0 week value)
M Value During Hyperinsulinemic Euglycemic Clamp
时间窗: 4 weeks
Absolute change of M value (glucose infusion rate during final 30 minute steady state)/ fat free body mass (kg) (4 week value - 0 week value)
次要结局
- Oral Glucose Tolerance Test (OGTT) Glucose 3-hour Area Under the Curve (AUC)(4 week)
- Oral Glucose Tolerance Test (OGTT) Insulin 3-hour Area Under the Curve(4 week)
- p-Hydroxyhippuric Acid(4 weeks)
- 3-(4'-Methoxyphenyl)Propionic Acid-3'-O-glucuronide(4 weeks)
- Hesperetin-7-O-glucuronide(4 weeks)
- Naringin-7-O-glucuronide(4 weeks)
- Fasting Triglyceride(4 weeks)
- 3-(3'-Hydroxy-4'-Methoxyphenyl)Hydracrylic(4 weeks)
- Hesperetin-3'-O-glucuronide(4 weeks)
- Hesperetin-3',7-0-diglucuronide(4 weeks)
- Fasting de Novo Lipogenesis(4 weeks)
研究者
Kimber Stanhope
Research Nutritional Biologist
University of California, Davis