The Metabolic Effects of Short-term Walnut Consumption in Subjects With the Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Insulin Resistance
研究概览
简要总结
Walnuts include many potentially beneficial micronutrients and phytochemicals, in this study we propose to examine the effects of walnuts independent of macronutrient content. The purpose of this proposal is to study in depth the short-term effects of walnut consumption in men and women with the metabolic syndrome.
Study Aim 1: To investigate the effects of walnuts (48gms per day over 3 days) on insulin resistance in subjects with the metabolic syndrome.
Study Aim 2: To investigate the effects of 48gms per day of walnuts over 3 days on lipids and inflammatory markers.
Study Aim 3: To assess the possible mechanisms of the biological effects of short-term walnut consumption through assessment of adipokines, resting metabolic rate, gene expression in white blood cells and the effect of walnuts when consumed as part of a mixed meal, on glucose excursions, insulin secretion and the excretion of gut peptides and free fatty acids.
详细描述
During the whole study period, you will be asked to maintain a constant body weight and you will receive advice from the dietitian regarding a weight stable diet and exercise pattern. You will also be asked to avoid walnuts during the entire study period. The intervention and the measurements during each of the visits are described below.
If you agree to be in this study, you will be asked to read and sign this consent form. After you sign the consent form, the following things will happen:
-
Screening Procedures: Screening procedures are tests and procedures that will be done to determine if you are eligible to take part in the research study. For this research study, the screening procedures include:
-
A detailed medical history and interview about lifestyle factors and medication use
-
A brief physical examination to document any abnormalities in your body appearance and measurement of weight, height and waist circumference.
-
Drawing of blood from the forearm for fasting blood glucose (blood sugar), lipid profile (cholesterol and other fats in blood), creatinine (a measure of your kidney function), and complete blood count (CBC).
-
Collection of urine for a HCG pregnancy test (women only)
For the blood tests, you will be asked not to eat or drink anything (except water) from 8 pm the previous evening until you arrive for the study visit the following morning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Metabolic Syndrome is defined as follows:
- •Central Obesity- for Europid men this is a waist circumference of > 94cm for women >80cm or BMI >
- •Plus 2 of the following 4 factors
- •Elevated triglycerides: > 150 mg/dL
- •Reduced HDL cholesterol < 40 mg/dL in men and < 50 mg/dL in women.
- •Raised diastolic blood pressure systolic BP > 130mmHg or diastolic BP > 85mmHg or treatment with antihypertensives.
- •Raised fasting plasma glucose > 100mg/dL or previously diagnosed type II diabetes.
排除标准
- •Subjects with diabetes requiring medication or insulin are excluded.
- •Subjects with any medical condition or on any treatment, which would interfere with the study outcomes or would make participation potentially harmful such as pregnancy or breastfeeding, anemia, heart disease, stroke, malabsorption syndromes according to a detailed medical history.
- •Present alcoholism or drug abuse or use of medications that could interfere with the study such as corticosteroids, growth hormone, antiretroviral therapy. These conditions will be screened for by a detailed history and systems review.
- •Individuals with nut allergy are excluded.
研究组 & 干预措施
Walnut Diet
48 Grams of Walnuts Daily
干预措施: Walnuts (Dietary Supplement)
Control Diet
Isocaloric Diet with No Walnuts
干预措施: Control (Dietary Supplement)
结局指标
主要结局
Insulin Resistance
时间窗: 4 days
HOMA-IR (homeostatic model assessment of insulin resistance) given in units as it is a ratio equation.
次要结局
未报告次要终点
研究者
Christos Mantzoros
Principal Investigator
Beth Israel Deaconess Medical Center