Design of Healthy and Sustainable Food and Ingredients Based on the Application of the Circular Economy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change of fecal microbiota from baseline to week 3.
研究概览
简要总结
There is a need to change eating patterns towards healthier diets with new sources of non-animal protein, obtained through more sustainable systems in line with strategies such as the European Green Deal, the "Farm to Fork" strategy, or the Common Agricultural Policy, among others.
The objective of this study, is to evaluate the nutritional effect of the developed products and their impact on the improvement and/or prevention of health problems (diabetes, intestinal dysbiosis), as well as to design and evaluation of the effect on health of a vegetable protein-based nutraceutical that also includes fiber and resistant starch.
详细描述
This study is designed as a 3-week, randomised, parallel study, focused on overweight/obese men and women between 20 and 65 years old.
All participants attend the Nutrition Intervention Unit of the Center for Nutrition Research in the University of Navarra for 2 times during the intervention (day 1 and day 21).
RECRUITMENT AND SCREENING:
The recruitment and screening of participants will be carried out through a Google Form questionnaire and by a phone call. At the same time, the database of people interested in participating in nutritional studies of the Center for Nutrition Research will be used, who will be contacted by phone or email to offer them the study. In addition, the study information and the recruitment form will also be posted on the Center for Nutrition Research website for anyone who wants to enroll in the study. On the other hand, the study will be disseminated through the channels available in the University of Navarra (Unclic, Alumni, emails, etc.) and through the placement of informative posters in the different buildings of the University of Navarra, as well as in public and private centers in Navarra, with prior authorization. If it is necessary, the study will be disseminated in the media such as in press, radio and TV.
The staff of the Nutritional Intervention Unit will assess the data provided by the potential participants and those who meet the inclusion criteria will be cited for the first visit of the study, which will take place in the Nutritional Intervention Unit of the Center for Nutrition Research in the University of Navarra. The information sheet and the informed consent will be sent to them beforehand so that they can read it for visit 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 20-65 years.
- •Body mass index: 25-29.9 kg/m2
- •Physical examination and vital signs normal or clinically irrelevant to the experiment.
- •Volunteers undergoing pharmacological treatment will be maintained if the dose is stable for at least 3 months before the start of the study, excluding treatments that alter gastrointestinal function, antidiabetics and stomach protectors.
- •Subjects must be able to understand and be willing to sign the informed consent, and must comply with all the procedures and requirements of the study.
- •Subjects have to present a stable weight (+/-3kg) in the three months prior to the start of the study.
排除标准
- •Subjects with relevant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, reflux, etc.
- •Subjects with frecuent flatulence, diarrhea and intestinal discomfort.
- •Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (for example, gastroduodenostomy).
- •Subjects with a high alcohol intake, more than 14 units (women) and 20 units (men).
- •Women who are breastfeeding or pregnant.
- •Subjects with liver disease.
- •Subjects with some type of cancer or undergoing treatment for it, or who have not had a period of at least 5 years since its eradication.
- •Subjects with allergies to any component of the product under study or any other food that interferes and makes it difficult to monitor the study.
- •Subjects who present some type of cognitive and/or psychic impairment.
- •Subjects in whom poor collaboration is expected or who, in the opinion of the investigator, have difficulties in following the study procedures.
- •Subjects who follow some type of supplementation that interferes with the study: probiotics, supplements rich in fiber, laxatives, protein supplements, etc.
- •Subjects who are immersed in some treatment for weight loss.
结局指标
主要结局
Change of fecal microbiota from baseline to week 3.
时间窗: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology.
次要结局
- Change of waist circumference from baseline to week 3.(The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).)
- Change of HOMA index from baseline to week 3.(The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).)
- Change of fullness from baseline to week 3.(The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).)
- Change of satisfaction from baseline to week 3.(The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).)
- Change of thirst from baseline to week 3.(The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).)
- Nutraceutical acceptance at week 3.(The Time Frame contains Clinical Investigation Day 2 (after 3 weeks of intervention).)
- Change of weight from baseline to week 3 (weighing machine)(The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).)
- Change of body mass index from baseline to week 3.(The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).)
- Change of glucose concentration from baseline to week 3.(The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).)
- Height at baseline.(The Time Frame contains one time point: Clinical Investigation Day 1 (at baseline).)
- Change of gastrointestinal symptoms from baseline to week 3.(The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).)
- Change of dietary intake from baseline to week 3.(The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).)
- Change of insulin concentration from baseline to week 3.(The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).)
- Change of hunger from baseline to week 3.(The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).)
- Change of want to eat something else sensation from baseline to week 3.(The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).)