The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women Substituting Walnuts for Different Food Components
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Non-HDL-cholesterol
研究概览
简要总结
The objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.
详细描述
The objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.
The metabolic effects of walnut consumption may not only relate to the ingested walnuts but also to what is not eaten when walnuts are consumed. We want to evaluate whether the metabolic changes are more pronounced if study participants are instructed to reduce carbohydrates or saturated fatty acids to remain on an isocaloric diet. In a third group we will test what food is omitted if no specific instructions are given. Furthermore half of the subjects in each group will be instructed to eat walnuts with meals and half as snacks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal healthy women and healthy men
- •Age >50 yrs
- •Written informed consent prior to study participation
排除标准
- •Known allergy to nuts
- •Evidence of alcohol (women >70g/week, men >140g/week), tabacco or drug abuse
- •Obesity ≥35 kg/m2
- •Diabetes mellitus
- •Hypertension >140/90 mmHg or history of hypertension
- •LDL-cholesterol >190 mg/dl, Triglycerides > 350 mg/dl
- •History of atherosclerotic disease
- •Liver disease of any etiology
- •Kidney disease of any etiology (GFR < 60 ml/min/1.73)
- •Uncontrolled thyroid disease or other endocrine diseases
- •Acute or chronic inflammatory diseases
- •Active malignancy
- •Current or previous (within 3 months) treatment with antidiabetic drugs, hypolipidemic drugs, antihypertensive drugs, anti-inflammatory drugs, vitamin E, hormonal replacement therapy
- •major surgical intervention within 3 months (or planned)
研究组 & 干预措施
Walnut-LIB
Western type diet including walnuts (43g/day); no specific recommendation
干预措施: walnuts (Other)
Control
Isocaloric western type diet w/o nuts, nut butters or nut oils of any kind
walnut-CH
Western type diet including walnuts (43g/day); Walnuts substitute carbohydrates
干预措施: walnuts (Other)
Walnut-SFA
Western type diet including walnuts (43g/day); Walnuts substitute saturated fatty acids
干预措施: walnuts (Other)
结局指标
主要结局
Non-HDL-cholesterol
时间窗: 8 weeks
次要结局
- ratio SFA:MUFA:PUFA(8 weeks)
- HOMA index(8 weeks)
- total-cholesterol(8 weeks)
- LDL-cholesterol(8 weeks)
- apoB(8 weeks)
- triglycerides(8 weeks)
- fasting glucose(8 weeks)
- caloric intake(8 weeks)
- ratio CH:fat:protein(8 weeks)
研究者
Klaus Parhofer
professor of Endocrinology and Metabolism
Ludwig-Maximilians - University of Munich