NL-OMON56688招募中不适用
Gut-brain health effects of PREbiotics in older adults with suspected COgnitive DEcline: the PRECODE study - PRECODE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 164
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
- •1. Written informed consent
- •2. Fluency in Dutch (speaking, reading, writing)
- •3. Age between 60-79 years (at screening)
- •4. Subjective cognitive decline plus (SCD+), (criteria of Jessen et al. 99):
- •4.1 Self-reported worsening of memory;
- •4.2 Indication of repetitive concerns (worries) associated with SCD;
- •4.3 With at least one of the following two features present:
- •(i) onset of SCD within the last 5 years;
- •(ii) age at onset >=60 years of age;
- •5. Presence of self-reported risk factors for cognitive decline based on the
- •weighted LIBRA criteria:
- •at least 2 modifiable risk factors need to be present:
- •(i) Diabetes mellitus type II 1 (has your doctor ever told you that you have
- •diabetes yes/no)
- •(ii) High cholesterol 1 (has your doctor ever told you your cholesterol is too
- •high yes/no)
- •(iii) Hypertension 1 (has your doctor ever told you that you have high blood
- •pressure yes/no)
- •(iv) High BMI 1,2
- •(v) Heart disease 1 (has your doctor ever told you that you have a heart or
- •blood vessel condition)
- •(vi) Unhealthy diet 1 (lower regular adherence to Mediterranean diet components
- •such as fish, vegetables, olive oil, pasta
- •and red wine)
- •1Criteria defined by the short version questions from LIBRA Administration
- •2 Defined as >=25 kg/m2 for 60-69 years old, and >=28 kg/m2 for >=70 years old,
- •based on self-reported height and weight.
排除标准
- •1. Current participation in other intervention trials
- •2.Technologically illiterate (complete incompetence in working with computers,
- •apps, online questionnaires, smartwatches etc.)
- •3.No internet access from home
- •4.Clinical diagnosis of >=1 of the following:
- •- Neurological pathology (e.g. MCI, dementia, multiple sclerosis, Parkinson*s
- •disease, epilepsy);
- •- Current malignant disease(s), with or without treatment;
- •- Current psychiatric disorder(s) (e.g. major depressive disorder, bipolar
- •disorder, schizophrenia, psychosis, anxiety, posttraumatic stress disorder);
- •- Symptomatic/decompensated cardiovascular disease (e.g. stroke, angina
- •pectoris, heart failure, recent myocardial infarction);
- •- Severe visual impairment or blindness
- •- Hearing or communicative impairment.
- •- Gastrointestinal tract disorder such as irritable bowel syndrome or
- •inflammatory bowel disease (e.g. Chron*s disease or ulcerative colitis).
- •5. Current or recent (<6 weeks) use of prebiotic, probiotic, or dietary fibre
- •supplement that may modulate the microbiota, or unwilling to stop the use of
- •supplements during the study
- •6. Current or recent (<6 weeks) of algae/phytoplankton supplements such as
- •spirulina or chlorella, or unwilling to stop the use of supplements during the
- •7. Use of psychotropic medication (anti-depressants, anti-psychotics)
- •8. Use of antibiotics in the 3 months before starting the study or planned use
- •during the study
- •9. Being an employee of the Human Nutrition and Health Division of Wageningen
- •University.
- •10. Significant cognitive impairment assessed using the Modified Telephone
- •Interview for Cognitive Status battery (TICS-m score <23)
- •11. Request to have Apo-E genotype result disclosed
- •12. Allergy to fish or shellfish
- •13. Having a contra-indication to MRI scanning including:
- •- Ferromagnetic implants:
- •- Active implantable medical devices such as: insulin pump / medicine pump /
- •neurostimulator; pacemaker / defibrillator;
- •- Other passive implants such as: punctured port-a-cath; synthetic heart valve
- •- Intra-orbital or intra-ocular metallic fragments
- •- Claustrophobia
研究者
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