The Effect of the Bioactives of Sea Buckthorn and Bilberry on the Risk of Metabolic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Serum Alanine aminotransferase (ALAT)
研究概览
简要总结
The study hypothesis is that the bioactive compounds of sea buckthorn berries (Hippophaë rhamnoides), their fractions, and bilberries (Vaccinium myrtillus). have positive effects on lipid and carbohydrate metabolism and will thus reduce the risk of developing metabolic diseases.
详细描述
The aim of the project was to investigate whether it is possible to reduce the risk of metabolic diseases with supplementing the diet with sea buckthorn berries (Hippophaë rhamnoides), their bioactive fractions, and bilberries (Vaccinium myrtillus). The study design was a randomized cross-over clinical trial. The participants were slightly and moderately overweight female subjects. In total, 110 female volunteers were recruited, and they followed four different berry diets (bilberry, sea buckthorn, sea buckthorn phenolic extract and sea buckthorn oil) in a randomized order for 33-35 days. Each intervention was followed by a wash-out period of 30-39 days. Blood samples were drawn and physical measurements were performed after each period. Eighty volunteers completed the study. Different markers of lipid and carbohydrate metabolism and inflammation were measured form the blood samples.
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
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI 26-34
- •total cholesterol 4.5-8 mmol/l
- •LDL chol >2.5 mmol/l
- •triglycerides <4 mmol/l
- •glucose <6 mmol/l
- •insulin <25 mU/l
- •blood pressure <160/99 mm Hg
- •hemoglobin >120 g/l
- •thyroid-stimulating hormone 0.3-4.2 mU/l
- •ALAT <60 U/l
- •creatinine <115 umol/l
排除标准
- •pregnancy
- •menopause,
- •regular smoking
- •previously diagnosed diabetes (other than gestational)
- •thyroid, renal, hematological, or hepatic dysfunction
- •previous myocardial infarction
- •cardiovascular medication
- •treatment with regular medication other than allergy medication or joint lubricates
- •on-going inflammatory disease
结局指标
主要结局
Serum Alanine aminotransferase (ALAT)
时间窗: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
次要结局
- Serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triacylglycerols(Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days))
- Plasma glucose(Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days))
- Serum high-sensitivity C-reactive protein(Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days))
- Serum gamma-glutamyl transpeptidase(Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days))
- Serum insulin(Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days))
- Serum soluble intercellular adhesion molecule(Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days))
- Serum tumor necrosis factor -alpha(Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days))
- Body mass index(Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days))
- Serum soluble vascular cell adhesion molecule(Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days))
- Serum adiponectin(Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days))
- Serum interleukine-6(Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days))
- Weight(Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days))
- Waist circumference(Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days))
- Body composition(Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days))
研究者
Jukka-Pekka Suomela
University Lecturer
University of Turku