NL-OMON56473招募中不适用
The EXPLAIN Study: Exploring plant-based meat analogues for their Impact on health - EXPLAI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- BMI of 23-40 kg/m2;
- •- Age 45-75 years;
- •- Willing to consume both meat and PBMAs;
- •- Stable body weight (lost/gained ±<3 kg over the last 3 months prior to
- •inclusion).
排除标准
- •- Diseases or prior surgeries affecting the stomach, liver, kidneys or
- •intestines (allowed i.e. appendectomy);
- •- Food allergies, intolerances (including lactose/gluten intolerance) for
- •products used in the study design and/or dietary restrictions interfering with
- •the study (including special diets, vegetarians and eating disorders);
- •- Cardiovascular diseases (e.g. heart failure. But hypertension up to 160 mmHg
- •is allowed for inclusion as indicated by the research physician) or cancer
- •(e.g. non-invasive skin cancer allowed);
- •- Anaemia defined as Hb concentrations <8.5 mmol/L for men and <7.5 mmol/L for
- •- Diagnosed with type 1 or type 2 diabetes;
- •- Blood pressure >160 mmHg*;
- •- Major mental disorders;
- •- Drug treated thyroid diseases (well substituted hypothyroidism is allowed for
- •inclusion);
- •- Diseases with a life expectation shorter than 5 years.
- •- Regular use of/receiving medication interfering with research outcomes (as
- •judged by research physician), such as use of glucose lowering drugs, insulin,
- •use of medication that impacts gastric emptying, use of antipsychotics;
- •- Starting or changing blood pressure medication type or dose during the study.
- •(Continuation of blood pressure medication usage is allowed during study);
- •- Use of anti-biotics over the last 3 months before study start.
- •- Dietary habits interfering with study design (vegan/vegetarian, ketogenic
- •diet etc.);
- •- Intention to change the intensity of exercise during the study period;
- •- Intention to lose weight during the study period;
- •- Current smokers (including use of e-cigarettes);
- •- Use of soft and/or hard drugs (cannabis included);
- •- Abuse of alcohol (alcohol consumption defined as >14 glasses (women) or >21
- •glasses (men) of alcoholic beverages per week);
- •- Use of strong vitamins or other dietary supplements (e.g. iron- or
- •B12-supplements, pre- or probiotics) expected to interfere with the study
- •- Donated blood within 2 months prior to the screening;
- •- Inability to comply with the study diet;
- •- Being pregnant or lactating or planning to become pregnant;
- •- Unable/unwilling to download a research application on the mobile phone;
- •- Inability to understand study information and/or communicate with staff;
- •- Inability/unwillingness to comply to staff instructions;
- •- Displaying misbehaviour towards other participants/staff;
- •- Participation in another study that involves an intervention within two
- •months prior to the intervention;
- •- Working or doing a thesis/internship at the division of Human Nutrition and
- •Health or the Laboratory of Microbiology of Wageningen University.
- •*Participants with a screening systolic blood pressure >145 mmHg - <=160 mmHg
- •need written permission for participation without having (medical) treatment
- •for the study period granted by their general practitioner after assessment of
- •their cardiovascular risk. Participants within this screening range that cannot
- •handover written clearance of their general practitioner will be excluded from
- •participation. Participants whose blood pressure has measured >140 mmHg
- •(systolic) or >90 mmHg (diastolic) one or more times during the study, will
- •receive a letter for referral to the general practitioner.
研究者
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