Functional Cereal Products and Contribution to the Regulation of Metabolism and Obesity-induced Chronic Low-grade Inflammation-MetaflammationBread
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change of serum total- and LDL-cholesterol concentrations of study participants as determined by biochemical analysis
研究概览
简要总结
The goal of this clinical trial is to find out the possible beneficial effects of a white wheat bread enriched with oat beta-glucans on mildly hypercholesterolemic subjects with overweight/obesity.
The main questions it aims to answer are:
Does the enriched bread lower total and LDL-cholesterol levels as well as the levels of inflammatory factors of the participants? Does the enriched bread positively change the composition of gut microbiota? Researchers will compare the enriched bread to a common white wheat bread to see if the enriched bread provides additional effect beyond a hypocaloric dietary plan that the participants of both groups are going to follow.
Participants will:
Take the enriched or the common bread every day for 8 weeks. Visit the clinic once every 2 weeks for checkups and tests.
详细描述
The effect of consuming the new bread product, a white wheat bread enriched with oat beta-glucans, on metabolic and inflammatory markers after an 8-week dietary intervention in volunteers with overweight/obesity will be studied. The volunteers will be randomly divided into two groups: group 1 (control) which will receive the conventional product i.e., white wheat bread and group 2 (intervention) which will receive the beta-glucans enriched bread. Both products will be consumed in isocaloric amounts and volunteers in both groups will follow a hypocaloric diet.
The following procedures/determinations will take place at the beginning and end of the intervention:
- Anthropometric characteristics: weight, height, body mass index (BMI), waist circumference, hip circumference, body composition.
- Classical biochemical parameters: glycemic control, lipid profile, liver enzymes, urea, creatinine, uric acid.
- Inflammation status.
- Estimation of daily energy intake by completing a food consumption frequency questionnaire.
- Assessment of physical activity.
At the beginning and at the end of the nutritional intervention, stool collection will take place. The samples will be subjected to microbiological and molecular analysis (Next Generation Sequencing, NGS) to determine the microbial populations and the intestinal microbiome.
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
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no underlying diseases
- •with LDL-cholesterol levels between 115-150 mg/dL
- •with 25<BMI<32 kg/m2
- •with stable body weight in the last 3 months before the intervention
- •with normal diet and exercise habits
排除标准
- •not suffer from diabetes mellitus, cardiovascular disease, chronic renal failure
- •not receive hypolipidemic treatment
- •not receive nutritional supplements that may affect blood lipid levels (eg omega-3 supplements, plant sterols/stanols) or the intestinal microbial flora (probiotics/prebiotics/antibiotics).
- •not be pregnant or lactating
- •not have food allergies
- •not have habits that prevent their compliance with the research protocol
研究组 & 干预措施
Control group
Dietary intervention with common white wheat bread in mildly hypercholesterolemic subjects with overweight/obesity.
干预措施: Control (Other)
Intervention group
Dietary intervention with white wheat bread enriched with oat beta-glucans in mildly hypercholesterolemic subjects with overweight/obesity.
干预措施: Intervention (Other)
结局指标
主要结局
Change of serum total- and LDL-cholesterol concentrations of study participants as determined by biochemical analysis
时间窗: From enrollment to the end of treatment at 8 weeks
Positive effect of consumption of the bread enriched with beta-gucans in the reduction of total- and LDL-cholesterol concentrations
次要结局
- Change in the composition of gut microbiota as determined by NGS analysis of fecal samples(From enrollment to the end of treatment at 8 weeks.)
研究者
Amalia Yanni
Senior Researcher
Harokopio University