Personalized Diet-driven Microbiota Alterations as a Tool for Improving Mood Status in Elderly
NCT ID: NCT03256929
Last Updated: 2020-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
200 participants
INTERVENTIONAL
2017-09-11
2021-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Depression and Increased Health Services Utilization Among Elderly Primary Care Patients
NCT00279526
Gut Feeling: Understanding the Mechanisms Underlying the Antidepressant Properties of Probiotics
NCT03893162
Effect of Depressin Screening and Care Program at Community Health Center
NCT01626703
Microbiome and the Gut-Brain Axis
NCT02693327
A Multi-component Intervention to Improve Medication Adherence in People With Depressive Disorders
NCT03668457
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Recent studies have suggested that depressive symptoms are more prevalent in individuals with impaired nutritional status. The intestinal microbial population (microbiota), known influenced by several factors including nutrition, age, and stress.
The microbiota is essential to human health, changes in composition microbiota play a role in metabolic, nutritional, physiological and immunological processes in the human body, recently reported also behavioral changes associated with anxiety and depression. The aging process is characterized by a decrease intestinal transit time, as a result of dental problems, decrease in saliva activity, and efficiency of digestion and absorption leading to changes in the microbiota composition, which causes an increase in sensitivity to the development of chronic and inflammatory diseases. Although other factors undoubtedly contribute to mental health decline in the elderly, the association of the intestinal microbiota of older people with inflammation, the clear association between diet and microbiota and the recent report on the correlation between changes in microbiota and depression have led us to hypothesize that diet can shape microbiota, which then affect mood status in older people and decreased depressive symptoms.
The purpose of the study is to examine the effect of a custom diet based on the composition of the intestinal bacterial population (compared with a diet for a healthy lifestyle that is not based on a microbiotic profile), on moods and depression among the elderly.
Before and after the intervention, several tests will be carried out, using stool sample for microbiota analysis, salivary cortisol measurement and clinical information (GDS, life style habits, CEBQ, FFQ), These measures will indicate participants' clinical, nutritional and mental situation before and after in order to probe the diet intervention impact on microbiota and its correlation to mental health.
The infrastructure of this research includes several aspects - mood, health and nutrition status that are main parameters in life quality of the third age, and the research is based on the complementary cooperation of social and behavior sciences and nutrition and life sciences experts.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
depression participants - intervention
personalized diet intervention based on microbiota analysis and health status
Personalized Diet-driven microbiota
Based on the results of the individual microbiota profile, the investigators will formulate a specific diet aiming to enrich the distinct microbiota with organisms correlated to better mental health. The dietitian will visit each participant twice a month.
depression participants - control
General information on nutrition and health
General information on nutrition and health
General information on nutrition and health. The dietitian will visit each participant twice a month.
pre-depression participants - control
General information on nutrition and health for pre-depression participants
General information on nutrition and health
General information on nutrition and health. The dietitian will visit each participant twice a month.
pre-depression participants - intervention
personalized diet intervention based on microbiota analysis and health status for pre-depression participants
Personalized Diet-driven microbiota
Based on the results of the individual microbiota profile, the investigators will formulate a specific diet aiming to enrich the distinct microbiota with organisms correlated to better mental health. The dietitian will visit each participant twice a month.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Personalized Diet-driven microbiota
Based on the results of the individual microbiota profile, the investigators will formulate a specific diet aiming to enrich the distinct microbiota with organisms correlated to better mental health. The dietitian will visit each participant twice a month.
General information on nutrition and health
General information on nutrition and health. The dietitian will visit each participant twice a month.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
60 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shamir Research Institute
UNKNOWN
Clalit Health Services
OTHER
Migal, Galilee Technology Center
OTHER
Tel Hai College
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ariella Ofran, M.D, MPH
Role: PRINCIPAL_INVESTIGATOR
Clalit Health Services
Snait Tamir, Prof.
Role: PRINCIPAL_INVESTIGATOR
Migal, Galilee Technology Center
Shmuel Shamai, Prof.
Role: PRINCIPAL_INVESTIGATOR
Shamir Research Institute
Adi Vitman- Schorr, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shamir Research Institute
Karen Jackson, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Migal, Galilee Technology Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shamir Research Institute
Qatzrin, Israel, Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHAMIRMB
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.