Effect of a Kefir Beverage on Immunity and Lipid Profile: An Exploratory Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Change from baseline in CD4 positive regulatory T cell counts in peripheral blood
研究概览
简要总结
This is an exploratory cluster randomized controlled trial to evaluate the effect of a kefir beverage, enriched with prebiotics components, on immunity, lipid profile and adiposity in a population-based study, using the family as the intervention unit.
详细描述
The gastrointestinal tract is populated by a collection of microorganisms, primarily bacteria, that interact with intestinal host cells. In the past two decades, several studies have demonstrated the effects of the intestinal microbiota on host physiological, metabolic and immunological processes and have revealed that the microbiota is fundamental to host body function. There is currently a growing interest in manipulating the intestinal microbiota to enhance the effects on health and welfare of the intestine. In this regard, since its introduction, the concept of prebiotics has stimulated both scientific and industrial interest. A dietary prebiotic is a selectively fermented ingredient that results in specific changes, in the composition and/or activity of the gastrointestinal microbiota, thus conferring benefits upon host health. To date, the prebiotics most widely evaluated in human clinical trials are inulin-type fructans (inulin, fructo-oligosaccharides, oligofructose) and galacto-oligosaccharides (GOS).
The investigators goal is to conduct a human clinical trial to evaluate the impacts of a functional-prebiotic beverage on immunity and metabolic profile.
This study will be performed on a family-oriented basis. 44 families/clusters (~ 150 children and adults, older than 3 years) will be selected to participate in the study and will be randomized into intervention group (n=22 families) and control (n=22 families) groups.
Weight, body mass index (BMI), waist circumference (WC), nutrient intake from food frequency questionnaire, physical activity, blood pressure, allergic sensitization, metabolic function (fasting blood glucose, HbA1c, insulin resistance and lipid profile), general lymphocyte overview (B-cells, T-cells and NK-cells) and sub-populations of T-helper cells (Th1, Th2, Th17 and T-regulatory), inflammation markers (C-reactive protein, interleukin-6 and tumor necrosis factor-alpha) will be measured at baseline and after 4 months.
Mixed effect models analysis will be performed to assess changes in the cardiometabolic and immune parameters.
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
Both groups will receive fermented dairy products with similar color, flavor and nutritional composition, except the prebiotic components, which will only be administered to the intervention group.
入排标准
- 年龄范围
- 3 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the index subject:
- •Female or male.
- •18 years and older.
- •Living in a family unit with two or more people.
- •For the other family members:
- •Female or male.
- •Age between 3 to 85 years.
- •At family level: at least two members will meet inclusion criteria but no exclusion criterion
- •Exclusion Criteria for the index subject and the other family members:
- •Alcoholism
- •Major cardiovascular disease
- •Major autoimmune diseases
- •Diseases or treatments that seriously affect the immune status
- •Neoplasia
- •Terminal disease
排除标准
- 未提供
研究组 & 干预措施
Prebiotic group.
Group of 22 families consuming a fermented dairy product with prebiotic components, once a day for 4 months.
干预措施: Prebiotic group (Dietary Supplement)
Placebo group
Group of 22 families consuming a dairy product with similar characteristics regarding color, flavor and nutritional composition, not containing the prebiotic components, once a day for 4 months.
干预措施: Placebo group (Dietary Supplement)
结局指标
主要结局
Change from baseline in CD4 positive regulatory T cell counts in peripheral blood
时间窗: 4 months
Flow cytometry analysis on peripheral blood
Change from baseline in Th1 cell counts in peripheral blood
时间窗: 4 months
Flow cytometry analysis on peripheral blood
Change from baseline in Th17 cell counts in peripheral blood
时间窗: 4 months
Flow cytometry analysis on peripheral blood
Change from baseline in Th2 cell counts in peripheral blood
时间窗: 4 months
Flow cytometry analysis on peripheral blood
次要结局
- Change from baseline in LDL cholesterol(4 months)
- Change from baseline in allergic sensitization measured through a battery of 11 skin prick test to common allergens(4 months)
- Change from baseline in total cholesterol(4 months)
- Change from baseline in HDL cholesterol(4 months)
- Change from baseline in B lymphocytes in peripheral blood(4 months)
- Change from baseline in tumor necrosis factor-alpha(4 months)
- Change from baseline in glucose(4 months)
- Change from baseline in HbA1c(4 months)
- Change from baseline in insulin(4 months)
- Change from baseline in hip circumference(4 months)
- Change from baseline in C-reactive protein(4 months)
- Change from baseline in body mass index (BMI)(4 months)
- Change from baseline in waist circumference(4 months)
- Change from baseline in food intake over the last 4 weeks(4 months)
- Change from baseline in triglycerides(4 months)
- Change from baseline in interleukin-6(4 months)
- Change from baseline in stool frequency(4 months)
- Change from baseline in T lymphocytes in peripheral blood(4 months)
- Change from baseline in Natural Killer (NK) lymphocytes in peripheral blood(4 months)
- Change from baseline in stool consistency (Bristol Stool Form Scale score)(4 months)
研究者
Maria del Mar Calvo Malvar
Principal Investigator
Hospital Clinico Universitario de Santiago