Insomnia in Older Adults: Impact of Personalized, Diet-Induced Alterations in the Microbiota

NCT03085446 | Completed

• 1 other identifier: TSHaifa
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Insomnia is a chronic mental health condition characterized by difficulty initiating and maintaining sleep with a prevalence of over 50% in Israeli adults ages 65 and above. It is associated with increased risks for chronic illnesses (e.g., cardiovascular disease), poor mental health (e.g., anxiety and depression), functional limitations, and cognitive decline. Available pharmacological and behavioral treatments focusing on reducing nighttime hyper-arousal offer limited success, and it appears that there is no "one size fits all" treatment for late life insomnia. Mounting evidence suggests that sleep is related to metabolic status, however, studies on the associations between sleep and dietary patterns are surprisingly scarce. 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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (2)

• ISI - Insomnia sevirity Index

  Insomnia Severity Index is based on DSM-4 carteria for insomnia surveys will be completed once at all four study waves (T0-T3)

  one year

• Actigraphy based Insomnia

  Objective sleep measurements: Actigraphy: wrist-worn ambulatory device/ To obtain a composite score for insomnia based on actigraphy, the following cutoff will be used: sleep efficiency\<=85%; and sleep onset latency (SOL) and/or wake after sleep onset (WASO) \>=30 minutes, at least 3 times per week. Two- week assessments will be repeated during all four study waves (T0-T3)

  one year

Secondary Outcomes (8)

• Insomnia by the consensus sleep diary

  one year

• Insomnia by the The Pittsburgh Sleep Quality Index

  one year

• Cognitive Functioning

  one year

• Motor Assessment- Gait

  one year

• Motor Assessment- Activity

  one year

Other Outcomes (4)

• Clinical and nutritional data collection - Anthropometric measures

  one year

• Eating Behavior Questionnaire (CEBQ)

  one year

• Nutritional data collection - Food Frequency Questionnaire (FFQ)

  one year

Study Arms (2)

PDM nutritional intervention

EXPERIMENTAL

Behavioral: PDM nutritional intervention

control

EXPERIMENTAL

General information on nutrition and health

Behavioral: General information on nutrition and health

Interventions

PDM nutritional intervention BEHAVIORAL

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).

PDM nutritional intervention

General information on nutrition and health BEHAVIORAL

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),

control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Based on DSM-5 criteria of diagnosed chronic insomnia in adults, participants will be included if they report difficulties in initiating or maintaining sleep or early morning awakening at least three nights per week that lasts for a minimum of three months, and impaired daytime functioning.

You may not qualify if:

• Based on standard clinical history questionnaires and sleep questionnaires, participants will be excluded if they are less than 65 years, have any significant visual or hearing impairments or chronic pain, if they have or had significant and unstable medical, neurological, or psychiatric illness, if they are alcohol or drug abusers or taking psychiatric medication, or if they had sleep apnea syndrome (SAS) or periodic limb movement disorder during sleep (PLMD).

Sponsors & Collaborators

• University of Haifa: lead
• The Max Stern Academic College Of Emek Yezreel: collaborator
• Migal, Galilee Technology Center: collaborator
• Tel Hai College: collaborator
• Clalit Health Services: collaborator
• Technion, Israel Institute of Technology: collaborator

Study Sites (1)

University of Haifa

Haifa, Mount Carmel, 31905, Israel

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Health

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Tamar Shochat, DSc

  University of Haifa

  PRINCIPAL INVESTIGATOR

• Uzi Milman, MD

  Clalit

  PRINCIPAL INVESTIGATOR

• Iris Haimov, Professor

  The Max Stern Yezreel Valley College

  PRINCIPAL INVESTIGATOR

• Maayan Agmon, Ph.D

  University of Haifa

  PRINCIPAL INVESTIGATOR

• Snait Tamir, Ph.D

  Migal, Galilee Technology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2017
• First Posted: March 21, 2017
• Study Start: February 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

IL (1)