OPTIEgg- Optimal Value Increase of Egg Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Change in plasma levels of inflammatory markers
研究概览
简要总结
The aim of this project is to evaluate daily intake of eggshell membrane taken as supplement (capsule), will reduce markers of inflammation in older people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
One of the employees will distribute the capsules and know which of the group is placebo and intervention. Everyone else involved in the project will be blinded for this knowledge.
入排标准
- 年龄范围
- 70 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The study will include home-dwelling men and women ≥ 70 years. All subjects have to be in a good enough condition to meet up at the Department of Nutrition, University of Oslo at two occasions during the study period.
排除标准
- •CRP >10 mg/L
- •Egg allergy
- •Use of medication affecting inflammation
- •Unstable use of medication or supplements last 3 months
- •Unwilling to keep the physical activity level, habitual dietary intake, tobacco use and weight stable during the study period
- •Severe illness last 3 months
- •Unwilling to perform physical tests
- •Eligibility
- •Diabetes type I or II, HbA1c ≥ 6.5 %
研究组 & 干预措施
Intervention
Participants will consume 2 capsules containing eggshell membrane(ESM) with breakfast every day in 4 weeks.
干预措施: Eggshell membrane (ESM) (Other)
Placebo
Participants will consume 2 capsules with no bioactive substance (placebo) with breakfast every day in 4 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Change in plasma levels of inflammatory markers
时间窗: Measured at baseline and after 4 weeks (end of study)
concentration of C-reactive protein (CRP)
次要结局
- Change in microbiota composition (optional)(Measured at baseline and after 4 weeks)
- Changes in metabolome plasma profile(Measured at baseline and after 4 weeks)
- Peripheral blood mononuclear cell (PBMC) gene expression(Measured at baseline and after 4 weeks)
- Changes in body weight(Measured at baseline and after 4 weeks)
- Changes in body mass index (BMI)(Measured at baseline and after 4 weeks)
- Changes in physical performance(Measured at baseline and after 4 weeks)
- Changes in body composition - measured by Bioimpedance (BIA)(Measured at baseline and after 4 weeks)
- Changes in markers related to lipid metabolism(Measured at baseline and after 4 weeks)
- Changes in satiety hormones(Measured at baseline and after 4 weeks)
- Change in muscle strength(Measured at baseline and after 4 weeks)
研究者
Stine Marie Ulven
Professor
University of Oslo