Development of a Novel Biscuit Enriched With β-glucans Isolated From Edible Mushrooms of Greek Habitats and Implementation of a Dietary Intervention That Includes Daily Consumption of This Biscuit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change from baseline in Gastrointestinal tolerance of novel biscuit during the interventional period and at 3 months.
研究概览
简要总结
The purpose of the study is to assess the effect of dietary intervention that includes the daily consumption of a novel biscuit (enriched with the selected mushrooms rich in β-glucans) on gut health related parameters of healthy subjects over 60 years old.
详细描述
After having been informed about the study and the potential risks, all subjects giving written informed consent will undergo screening to determine eligibility for study entry (inclusion criteria). At baseline, the participants will provide biological samples and they will be randomly assigned in a double-blind manner (investigator and participant) to one of the intervention groups, i.e. consumption of the novel biscuit (biscuit enriched with mushroom powder containing 3g of β-glucans) or consumption of the placebo biscuit for 3 months,. After a washout period of 2 months, the subjects will consume the novel biscuit or the placebo biscuit in a cross-over design for 3 more months. Throughout the interventional period subjects' dietary intake, anthropometrical data and gastrointestinal symptoms will be monitored. Meanwhile at baseline and at the end of each trimester physical activity, mental health and sleep habits will be evaluated with the use of questionnaires and biological samples will be provided for further analysis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy individuals aged 60-80 years old, of both sexes/genders
排除标准
- •no recent weight loss and extreme dietary behaviors;
- •no history of gastrointestinal disease, chronic constipation, chronic/acute diarrhea, autoimmune disease, coronary disease, liver and/or kidney malfunction;
- •no consumption of antibiotics two months prior to the initiation of the intervention;
- •no consumption of probiotics and/or prebiotics and/or dietary fiber supplements two weeks prior to the initiation of the intervention.
研究组 & 干预措施
Biscuit enriched with mushroom powder
Daily consumption of a novel biscuit enriched with mushroom powder containing 3g of β-glucans
干预措施: Novel biscuit enriched with mushroom powder containing 3g of β-glucans (Other)
Placebo biscuit
Daily consumption of a placebo biscuit
干预措施: Placebo biscuit (Other)
结局指标
主要结局
Change from baseline in Gastrointestinal tolerance of novel biscuit during the interventional period and at 3 months.
时间窗: Gastrointestinal symptoms will be evaluated at baseline, during and at the end of each intervention. (3 months period)
Gastrointestinal (GI) symptomatology will be recorded through a 7d-questionnaire in certain time periods.The intensity of each GI symptom (abdominal pain, distension, flatulence and borborygmi) will be measured daily on a scale of 0-4, where '0' represents absence of symptoms and '4' severe symptoms. The possible range for each weekly symptom score is 0-28, and for the total symptom score 0-112. Frequency and consistency of evacuations will be also noted, and presence of diarrhoea will be defined.
Change from baseline to the effect on the intestinal microbial populations and their metabolic products [i.e. Short-Chain Fatty Acids (SCFA)] (prebiotic effect) at 3 months.
时间窗: The levels of microbial populations and their metabolic products e.g. SCFA will be measured at baseline and at the end of each interventional period.(3 months period)
Microbial populations will be quantified with 16SRNA sequencing and quantitative Polymerase Chain Reaction (PCR). SCFAs will be quantified with Gas chromatography.
次要结局
- Change from baseline in Metabolic health at 3 months.(Metabolic health will be measured at baseline and at the end of each interventional period.(3 months period))
- Change from baseline in blood serum Parathyroid Hormone at 3 months.(Blood serum Parathyroid Hormone will be measured at baseline and at the end of each interventional period.(3 months period))
- Change from baseline in blood serum Insulin at 3 months.(Blood serum Insulin will be measured at baseline and at the end of each interventional period.(3 months period))
- Change from baseline in Immune system reinforcement at 3 months.(Immune system reinforcement will be measured at baseline and at the end of each interventional period.(3 months period))
- Change from baseline in Dietary intake at 3 months.(Dietary intake will be measured at baseline and at the end of each interventional period.(3 months period))
- Change from baseline in blood serum 25-hydroxy vitamin D at 3 months.(Blood serum 25-hydroxy vitamin D will be measured at baseline and at the end of each interventional period.(3 months period))
研究者
Adamantini Kyriakou
Associate Professor
Harokopio University