DepressionNCT03256929
Personalized Diet-driven Microbiota Alterations as a Tool for Improving Mood Status in Elderly
A study testing Personalized Diet-driven microbiota and General information on nutrition and health in people with Depression, run by Tel Hai College at 1 site in Israel.
Trial summary
The propose of the study is a multi-disciplinary project connecting nutritional and health sciences with social and behavioral sciences, and aimed at understanding the microbiota changes related to the third age and their effects on mood and mental health. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Personalized Diet-driven microbiota and General information on nutrition and health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Sep 2017to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects of both sexes aged 60 - 80, from northeastern Israel, Jewish, Druze and Arab populations, will be recruited. Only healthy, independent people who agreed to take part in the study and show depressive symptoms according to the Geriatrics Depression Scale.
Who cannot join
- Elderly people with depression who are drug-treated or elderly who are nursing his/her partner, and who are treated with antibiotics at least 4 weeks before taking fecal samples.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shamir Research Institute
Qatzrin, Israel, 1290000
Ziv Mozes, M.Sc. RD, 972503553800, zivo13@gmail.com
Adi Vitman- Schorr, Ph.D, 972506301998, adivitman@gmail.com
About this study
The propose of the study is a multi-disciplinary project connecting nutritional and health sciences with social and behavioral sciences, and aimed at understanding the microbiota changes related to the third age and their effects on mood and mental health. The research aims are primarily practical: They will explore the influence of the gut flora on depression, which could help us to recommend diets that might reduce the risk of developing depression. The novelty of this proposal is in the design of personalized diet-driven microbiota alterations and health status to modulate depression in elderly. For the first time the improvement of mental health in the elderly will be studied through a nutritional and food habits approach based on microbiota changes upon ageing.
Read the detailed description
Depressive symptoms are highly prevalent in older populations, is one of the most serious public health problems faced by modern societies. The problems caused by depression, such as functional impairments, lead to decreased quality of life, poor recovery from illnesses and increased mortality in the elderly. Researchers have found that there are many possible connections between personal or physical variables and the risk of developing depression; it can be caused by sociodemographic factors, or cognitive and functional impairment, nutritional status is also related to development of depression.
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
- Depression
- Being tested
- Personalized Diet-driven microbiota, General information on nutrition and health
- Keywords
- Personalized Diet, Microbiota, Depression, Elderly, Gut flora
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Diet-driven microbiotaBehavioural
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 healthBehavioural
General information on nutrition and health. The dietitian will visit each participant twice a month.
| Study group | Role | What they receive |
|---|---|---|
| depression participants - intervention | Experimental | personalized diet intervention based on microbiota analysis and health status Receives: Behavioral: Personalized Diet-driven microbiota |
| depression participants - control | Experimental | General information on nutrition and health Receives: Behavioral: General information on nutrition and health |
| pre-depression participants - control | Experimental | General information on nutrition and health for pre-depression participants Receives: Behavioral: General information on nutrition and health |
| pre-depression participants - intervention | Experimental | personalized diet intervention based on microbiota analysis and health status for pre-depression participants Receives: Behavioral: Personalized Diet-driven microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental health status - Depression
Depression will be assessed using the Geriatric Depression Scale (GDS). changes in test score
Measured: 1 year
Secondary outcomes (5)
Microbiota profile
Microbiota composition will be characterized from feces. The stool specimens will be collected and immediately put in buffer and stored at -20ºC for analysis and then will be kept at -80ºC in a locked freezer. The very low temperature is of significance to avoid variability in the stool bacterial composition and to preserve bacterial DNA in fecal samples. Total microbial DNA will be extracted using the PowerSoil DNA extraction kit (MoBio) and then submitted to 16S rRNA gene amplicon sequencing using paired end Illumina technology.
Measured: 1 year
Salivary Cortisol
Salivary Cortisol Measurement - The sampling procedure is simple and non-invasive. The saliva sample will be collected by using the Salivettes and freezed as is. On the day of the assay, Salivette™ samples can be thawed and then centrifuged at low speed to separate the saliva sample from the gauze. The cortisol in saliva is remarkably stable and will be measured by the salivary cortisol kit.
Measured: 1 year
life style habits
The life style habits questionnaire is based on MABAT ZAHAV, National Health and Nutrition Survey (Aged 60 and over) 2005-2006, Ministry of Health, Israel and includes demographic details, questions on health status, dental health, functional, cognitive and emotional states, use of medications and nutrition supplements, alcohol consumption, physical activity, smoking habits, eating and dieting patterns, nutritional knowledge and attitudes.
Measured: 1 year
Nutritional data collection - Food Frequency Questionnaire - FFQ
Habitual dietary intake information that will be assessed using the Food Frequency Questionnaire (FFQ)
Measured: 1 year
Eating Behavior Questionnaire - CEBQ
Appetite, gastrointestinal problems, and chewing and swallowing problems will be assessed using the Composite Eating Behavior Questionnaire (CEBQ)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start11 Sep 2017
- Primary completion30 Dec 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first stage will be mapping all of the aged population of the research area, who will be interviewed (after receiving their consent) in order to determine those who are depressed. 200 depressed and pre-depression individuals (according to the GDS) will be chosen, and divided randomly into two groups- one will undergo the diet- driven microbiota adjustment personalized-intervention (nutrition advisory), and the other will get general information on nutrition and health .
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Hai College
- Sponsor type
- University, hospital or other
- Collaborators
- Shamir Research Institute, Clalit Health Services, Migal, Galilee Technology Center
- Responsible party
- Sponsor
- Investigators
- Ariella Ofran, M.D, MPH, Principal investigator, Clalit Health ServicesSnait Tamir, Prof., Principal investigator, Migal, Galilee Technology CenterShmuel Shamai, Prof., Principal investigator, Shamir Research InstituteAdi Vitman- Schorr, Ph.D, Principal investigator, Shamir Research InstituteKaren Jackson, Ph.D, Principal investigator, Migal, Galilee Technology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256929
- Sponsor's protocol ID
- SHAMIRMB
- Status last verified
- Oct 2020
- First submitted
- 12 Aug 2017
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Diet-driven Microbiota Alterations as a Tool for Improving Mood Status in Elderly
- ClinicalTrials.gov ID
- NCT03256929
- Acronym / sponsor ID
- SHAMIRMB
- Conditions
- Depression
- Keywords
- Personalized Diet, Microbiota, Depression, Elderly, Gut flora
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tel Hai CollegeUniversity, hospital or other
- Collaborators
- Shamir Research Institute, Clalit Health Services, Migal, Galilee Technology Center
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The propose of the study is a multi-disciplinary project connecting nutritional and health sciences with social and behavioral sciences, and aimed at understanding the microbiota changes related to the third age and their effects on mood and mental health. The research aims are primarily practical: They will explore the influence of the gut flora on depression, which could help us to recommend diets that might reduce the risk of developing depression. The novelty of this proposal is in the design of personalized diet-driven microbiota alterations and health status to modulate depression in elderly. For the first time the improvement of mental health in the elderly will be studied through a nutritional and food habits approach based on microbiota changes upon ageing.
Detailed description
Depressive symptoms are highly prevalent in older populations, is one of the most serious public health problems faced by modern societies. The problems caused by depression, such as functional impairments, lead to decreased quality of life, poor recovery from illnesses and increased mortality in the elderly. Researchers have found that there are many possible connections between personal or physical variables and the risk of developing depression; it can be caused by sociodemographic factors, or cognitive and functional impairment, nutritional status is also related to development of depression.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The first stage will be mapping all of the aged population of the research area, who will be interviewed (after receiving their consent) in order to determine those who are depressed. 200 depressed and pre-depression individuals (according to the GDS) will be chosen, and divided randomly into two groups- one will undergo the diet- driven microbiota adjustment personalized-intervention (nutrition advisory), and the other will get general information on nutrition and health .
| Arm | Type | Receives |
|---|---|---|
| depression participants - intervention | Experimental | Behavioral: Personalized Diet-driven microbiotapersonalized diet intervention based on microbiota analysis and health status |
| depression participants - control | Experimental | Behavioral: General information on nutrition and healthGeneral information on nutrition and health |
| pre-depression participants - control | Experimental | Behavioral: General information on nutrition and healthGeneral information on nutrition and health for pre-depression participants |
| pre-depression participants - intervention | Experimental | Behavioral: Personalized Diet-driven microbiotapersonalized diet intervention based on microbiota analysis and health status for pre-depression participants |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects of both sexes aged 60 - 80, from northeastern Israel, Jewish, Druze and Arab populations, will be recruited. Only healthy, independent people who agreed to take part in the study and show depressive symptoms according to the Geriatrics Depression Scale.
Key exclusion criteria (1 listed)
- Elderly people with depression who are drug-treated or elderly who are nursing his/her partner, and who are treated with antibiotics at least 4 weeks before taking fecal samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Diet-driven microbiotaBased 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. | Behavioural | depression participants - intervention, pre-depression participants - intervention |
| General information on nutrition and healthGeneral information on nutrition and health. The dietitian will visit each participant twice a month. | Behavioural | depression participants - control, pre-depression participants - control |
Primary outcome
Mental health status - Depression
Time frame: 1 year
Depression will be assessed using the Geriatric Depression Scale (GDS). changes in test score
5 secondary outcomes
Microbiota profile
Time frame: 1 year
Salivary Cortisol
Time frame: 1 year
life style habits
Time frame: 1 year
Nutritional data collection - Food Frequency Questionnaire - FFQ
Time frame: 1 year
Eating Behavior Questionnaire - CEBQ
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariella Ofran, M.D, MPH principal investigator
Clalit Health Services
Snait Tamir, Prof. principal investigator
Migal, Galilee Technology Center
Shmuel Shamai, Prof. principal investigator
Shamir Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Diet-driven microbiota and General information on nutrition and health in people with Depression, run by Tel Hai College at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziv Mozes, M.Sc. RD (972503553800, zivo13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental health status - Depression (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.