Investigation of Health Effects of Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk Towards Established and Molecular Cardiovascular Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Changes in Diastolic Blood Pressure
研究概览
简要总结
This cross-over study investigates health effects of dietary intake of whole walnuts towards cardiovascular risk factors in adults under low cardiovascular risk.
Investigators hypothesize that daily intake of whole nuts as a replacement meal, would improve cardiovascular risk factors, including traditional risk factors and molecular biomarkers.
The participants are randomly assigned to receive either study treatment, or no treatment, and are crossed after five weeks.
The study subjects are instructed to continue with their habitual diet and physical activity.
详细描述
Recent literature data raise important questions on the beneficial effect of dietary fats. Dietary intake of nuts, although with high caloric burden, is however characterized with high intake of fatty acids with known beneficial health effects. Those fatty acids include mono- (MUFA) and polyunsaturated fatty acids (PUFA), to whom beneficial health effects are ascribed.
Among nuts, walnuts are characterized with comparatively high levels of MUFA and PUFA, especially content of alpha-linolenic PUFA, considered essential fatty acid, since not synthesized endogenously in humans. Dietary intake of alpha-linolenic acid is shown to be inversely related with cardiovascular risk factors, both in interventional studies and epidemiological cohorts. Molecular background of alpha-linolenic actions is bidirectional, and includes the action itself, as well as beneficial endogenous conversion towards long-chain fatty acids, including eicosapentaenoic and docosahexaenoic fatty acid.
Although high caloric intake is indicated with intake of walnuts, literature data suggest that consumption of walnuts does not increase body weight.
Dietary intake of walnuts has been shown to decrease cholesterol fractions, triglycerides and apolipoproteins in adult population. Also, consumption of walnuts was associated with decrease in blood pressure.
The study design is cross-over, controlled, randomized nutritional intervention. The participants are randomly assigned to receive either study treatment, or no treatment, and are crossed after five weeks.
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
盲法说明
Independent researcher will perform statistical analyses, without prior knowledge on study treatment allocation.
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of at least one of the following criteria, formerly assessed through routine medical examination:
- •dyslipidemia, defined as the presence of either: elevated total cholesterol (>5.2 mmoL/L), and/or elevated LDL-cholesterol (>3.4 mmoL/L), and/or elevated triglycerides (>1.7 mmoL/L), and/or decreased HDL-cholesterol (<1.6 mmoL/L)
- •elevated blood pressure (systolic/diastolic ≥120/80 mmHg), or regular anti-hypertension therapy
排除标准
- •presence of allergy on any nuts
- •presence of any chronic disease, excluding following conditions: hypertension and diabetes mellitus type 2
- •statin therapy
- •pregnancy and/or lactation
研究组 & 干预措施
Walnut
At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).
Treatment arm includes 56 g of whole walnuts daily.
干预措施: Whole Walnuts (Dietary Supplement)
Control
At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).
结局指标
主要结局
Changes in Diastolic Blood Pressure
时间窗: Baseline, 5 weeks, 10 weeks
Changes in Diastolic Blood Pressure from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
Changes in LDL-cholesterol
时间窗: Baseline, 5 weeks, 10 weeks
Changes in LDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Changes in Systolic Blood Pressure
时间窗: Baseline, 5 weeks, 10 weeks
Changes in Systolic Blood Pressure, from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
次要结局
- Changes in triglycerides(Baseline, 5 weeks, 10 weeks)
- Changes in liver function parameters(Baseline, 5 weeks, 10 weeks)
- Changes in number of leukocyte cells(Baseline, 5 weeks, 10 weeks)
- Changes in caloric intake of fats(Baseline, 5 weeks, 10 weeks)
- Changes in HDL-cholesterol(Baseline, 5 weeks, 10 weeks)
- Changes in renal function parameters(Baseline, 5 weeks, 10 weeks)
- Changes in total cholesterol(Baseline, 5 weeks, 10 weeks)
- Changes in percent of total body fat(Baseline, 5 weeks, 10 weeks)
- Changes in caloric intake of carbohydrates(Baseline, 5 weeks, 10 weeks)
- Changes in glucose metabolism biomarkers(Baseline, 5 weeks, 10 weeks)
- Changes in body weight(Baseline, 5 weeks, 10 weeks)
- Level of Physical Activity(Baseline)
- Changes in hematological parameters(Baseline, 5 weeks, 10 weeks)
- Changes in waist circumference(Baseline, 5 weeks, 10 weeks)
- Psychological parameters(5 weeks)
- Changes in total caloric intake(Baseline, 5 weeks, 10 weeks)
- Changes in caloric intake of vitamin D(Baseline, 5 weeks, 10 weeks)