Insomnia in Older Adults: Impact of Personalized, Diet-Induced Alterations in the Microbiota
NCT ID: NCT03085446
Last Updated: 2020-11-03
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
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COMPLETED
NA
80 participants
INTERVENTIONAL
2017-02-01
2020-05-01
Brief Summary
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The ability of gut microbiota to communicate with the brain is emerging as an exciting concept in health and disease and provides the rationale for the present project. Findings demonstrate that gut microbiota modulates mental capacities such as brain plasticity and cognitive functions in older adults, as well as stress related mental illness. The composition of the intestinal microbiota in older people (\>65 years) differs from the core microbiota and diversity levels of younger adults. With age, gut populations of beneficial microbes show a marked decline. As diet has been shown to markedly promote microbiota biodiversity, it is hypothesized that diet-induced changes in microbiota may provide a novel approach for the treatment of mental health. Although insomnia is strongly linked to mental health (e.g., depression and anxiety), as well as cognitive and motor performance, the effects of diet-induced microbiota alterations, based on individual microbiota composition, on late life insomnia is currently unknown.
The proposed project will be the first to investigate the associations between gut microbiota and sleep, and assess the potential of a six-months personalized, diet-induced microbiota alterations intervention (PDM), aimed to improve insomnia in older adults. We will also look at cognitive, motor and mental health factors as possible mediators in this relationship. Specifically, we will test the associations between microbiota composition and sleep quality, both cross-sectionally and longitudinally, i.e., following a PDM intervention; evaluate the impact of PDM on changes in cognitive, motor and mental health functions; and identify the mediating roles of changes in cognitive, motor and mental functioning on the effects of a PDM intervention on sleep quality. Findings are expected to improve the quality of life of older adults by enhancing their sleep, functional status, mental health and overall wellbeing.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PDM nutritional intervention
PDM nutritional intervention
personalized, diet-induced alterations in microbiota (PDM) for six months. (1) A 14-day running-in, no-treatment baseline assessment of all outcomes (T0); (2) A 6-month intervention period, with repeated assessments of all outcomes during the last two weeks of months 3 (T1) and 6 (T2). (3) A 12 month follow up (T3).
control
General information on nutrition and health
General information on nutrition and health
General information on nutrition and health for six months: (1) A 14-day running-in, no-treatment baseline assessment of all outcomes (T0); (2) A 6-month intervention period, with repeated assessments of all outcomes during the last two weeks of months 3 (T1) and 6 (T2). (3) A 12 month follow up (T3),
Interventions
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PDM nutritional intervention
personalized, diet-induced alterations in microbiota (PDM) for six months. (1) A 14-day running-in, no-treatment baseline assessment of all outcomes (T0); (2) A 6-month intervention period, with repeated assessments of all outcomes during the last two weeks of months 3 (T1) and 6 (T2). (3) A 12 month follow up (T3).
General information on nutrition and health
General information on nutrition and health for six months: (1) A 14-day running-in, no-treatment baseline assessment of all outcomes (T0); (2) A 6-month intervention period, with repeated assessments of all outcomes during the last two weeks of months 3 (T1) and 6 (T2). (3) A 12 month follow up (T3),
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
65 Years
ALL
Yes
Sponsors
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The Max Stern Academic College Of Emek Yezreel
OTHER
Migal, Galilee Technology Center
OTHER
Tel Hai College
OTHER
Clalit Health Services
OTHER
Technion, Israel Institute of Technology
OTHER
University of Haifa
OTHER
Responsible Party
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Principal Investigators
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Tamar Shochat, DSc
Role: PRINCIPAL_INVESTIGATOR
University of Haifa
Uzi Milman, MD
Role: PRINCIPAL_INVESTIGATOR
Clalit
Iris Haimov, Professor
Role: PRINCIPAL_INVESTIGATOR
The Max Stern Yezreel Valley College
Maayan Agmon, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Haifa
Snait Tamir, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Migal, Galilee Technology Center
Locations
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University of Haifa
Haifa, Mount Carmel, Israel
Countries
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Other Identifiers
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TSHaifa
Identifier Type: -
Identifier Source: org_study_id