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

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Behavioral: Personalized Diet-driven microbiota; Behavioral: General information on nutrition and health

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ziv Mozes, M.Sc. RD; Phone Number: 972503553800; Email: zivo13@gmail.com

Study Locations

• Israel
  • Katzrin, Israel, 1290000
    • Recruiting
    • Shamir Research Institute
    • Contact: Ziv Mozes, M.Sc. RD; Phone Number: 972503553800; Email: zivo13@gmail.com
    • Contact: Adi Vitman- Schorr, Ph.D; Phone Number: 972506301998; Email: adivitman@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: depression participants - intervention; personalized diet intervention based on microbiota analysis and health status	Behavioral: 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.
EXPERIMENTAL: depression participants - control; General information on nutrition and health	Behavioral: General information on nutrition and health; General information on nutrition and health. The dietitian will visit each participant twice a month.
EXPERIMENTAL: pre-depression participants - control; General information on nutrition and health for pre-depression participants	Behavioral: General information on nutrition and health; General information on nutrition and health. The dietitian will visit each participant twice a month.
EXPERIMENTAL: pre-depression participants - intervention; personalized diet intervention based on microbiota analysis and health status for pre-depression participants	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental health status - Depression	Depression will be assessed using the Geriatric Depression Scale (GDS). changes in test score	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	1 year
Nutritional data collection - Food Frequency Questionnaire - FFQ	Habitual dietary intake information that will be assessed using the Food Frequency Questionnaire (FFQ)	1 year
Eating Behavior Questionnaire - CEBQ	Appetite, gastrointestinal problems, and chewing and swallowing problems will be assessed using the Composite Eating Behavior Questionnaire (CEBQ)	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric measure 1	Measurements of body weight in kilograms	1 year
Anthropometric measure 2	Change in body fat percentage	1 year

Collaborators and Investigators

• Sponsor: Tel Hai College
• Collaborators: Clalit Health Services; Migal, Galilee Technology Center; Shamir Research Institute
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 11, 2017
• Primary Completion (ANTICIPATED): December 30, 2020
• Study Completion (ANTICIPATED): February 1, 2021

Study Registration Dates

• First Submitted: August 12, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (ACTUAL): August 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Depression; Elderly; Microbiota; Gut flora; Personalized Diet
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: SHAMIRMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No