Personalized Diet-driven Microbiota Alterations as a Tool for Improving Mood Status in Elderly

NCT03256929 | Unknown DMC

• 1 other identifier: SHAMIRMB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depression

Keywords

Personalized Diet; Microbiota; Depression; Elderly; Gut flora

Outcome Measures

Primary Outcomes (1)

• Mental health status - Depression

  Depression will be assessed using the Geriatric Depression Scale (GDS). changes in test score

  1 year

Secondary Outcomes (5)

• Microbiota profile

  1 year

• Salivary Cortisol

  1 year

• life style habits

  1 year

• Nutritional data collection - Food Frequency Questionnaire - FFQ

  1 year

• Eating Behavior Questionnaire - CEBQ

  1 year

Other Outcomes (2)

• Anthropometric measure 1

  1 year

• Anthropometric measure 2

  1 year

Study Arms (4)

depression participants - intervention

EXPERIMENTAL

personalized diet intervention based on microbiota analysis and health status

Behavioral: Personalized Diet-driven microbiota

depression participants - control

EXPERIMENTAL

General information on nutrition and health

Behavioral: General information on nutrition and health

pre-depression participants - control

EXPERIMENTAL

General information on nutrition and health for pre-depression participants

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

Behavioral: Personalized Diet-driven microbiota

Interventions

Personalized Diet-driven microbiota BEHAVIORAL

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 - intervention; pre-depression participants - intervention

General information on nutrition and health BEHAVIORAL

General information on nutrition and health. The dietitian will visit each participant twice a month.

depression participants - control; pre-depression participants - control

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel Hai College: lead
• Shamir Research Institute: collaborator
• Clalit Health Services: collaborator
• Migal, Galilee Technology Center: collaborator

Study Sites (1)

Shamir Research Institute

Qatzrin, Israel, 1290000, Israel

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Health

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Ariella Ofran, M.D, MPH

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

• Snait Tamir, Prof.

  Migal, Galilee Technology Center

  PRINCIPAL INVESTIGATOR

• Shmuel Shamai, Prof.

  Shamir Research Institute

  PRINCIPAL INVESTIGATOR

• Adi Vitman- Schorr, Ph.D

  Shamir Research Institute

  PRINCIPAL INVESTIGATOR

• Karen Jackson, Ph.D

  Migal, Galilee Technology Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziv Mozes, M.Sc. RD

CONTACT

972503553800; zivo13@gmail.com

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

Model Details: 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 .

Study Record Dates

• First Submitted: August 12, 2017
• First Posted: August 22, 2017
• Study Start: September 11, 2017
• Primary Completion: December 30, 2020
• Study Completion: February 1, 2021
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)