Effects of Sucrose-sweetened Beverage in African-American and Caucasian Women.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Total cholesterol
研究概览
简要总结
The main objective of this pilot study is to measure changes in metabolic risk factors of cardiovascular disease and type 2 diabetes in response to sugar-sweetened beverages in African-American and non-Hispanic white women.
详细描述
This is a dietary intervention during which participants will consume a SSB daily, with each meal for two weeks. At the beginning and end of the two-week intervention, participants will have blood drawn under fasting and postprandial (after a meal) conditions for the measurement of lipid risk factors associated with cardiovascular disease. Participants will also undergo an oral glucose tolerance test (OGTT) to assess insulin sensitivity. All sugar-sweetened beverages will be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
All outcomes measures are analyzed using only the participant's study ID number.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI 25 - 35 kg/m2
排除标准
- •Does not identify as African-American or non-hispanic White
- •Glucose intolerance (fasting glucose >100 mg/dl)
- •Evidence of liver disorder (AST or ALT >200% upper limit of normal range)
- •Evidence of kidney disorder (>2.0mg/dl creatinine)
- •Evidence of thyroid disorder (out of normal range)
- •Systolic blood pressure consistently over 140mmHg or diastolic blood pressure over 90mmHg
- •Triglycerides > 150mg/dl
- •LDL-C > 130mg/dl
- •Hemoglobin < 8.5 g/dL
- •Pregnant or lactating women
- •Current, prior (within 12 months), or anticipated use of any hypolipidemic or anti-diabetic agents PROTOCOL TITLE: The Effects of Sucrose Beverage on African-American and Caucasian Women (SAAC) Study Page 4 of 18 Revised: November 27, 2013
- •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 chronic corticosteroids (everyday use for a month or longer)
- •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, food allergies, 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 CCRC R.N.s as being unsuitable for long-term infusions and multiple blood draws from a catheter
- •Any other condition that, in the opinion of the investigators, would put the subject at risk
- •We will exclude individuals from each of the following special populations:
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers < 18 years)
- •Pregnant women
- •Prisoners
结局指标
主要结局
Total cholesterol
时间窗: 2 weeks
Fasting and postprandial plasma cholesterol
Triglycerides
时间窗: 2 weeks
Fasting and postprandial plasma triglycerides
Low-density lipoprotein (LDL)
时间窗: 2 weeks
Fasting and postprandial plasma low-density lipoprotein (LDL)
Oral glucose tolerance test (OGTT)
时间窗: 2 weeks
Participants will drink a beverage containing 75g of glucose and blood will be drawn before the drink and at 30 minutes, 60 minutes, 90 minutes, 120 minutes and 180 minutes after the drink. Plasma glucose and insulin will be measured at each time point.
次要结局
- Waist circumference(2 weeks)