NCT04401930

Brief Summary

Aging is characterized by low-grade inflammatory state, supported by impairment oxidative balance and endocrine changes, leading to changes in: body composition, such as decrease in lean body mass and increase in adipose tissue; resting metabolic rate; immune function; cognitive impairment. According to the Academy of Nutrition and Dietetics all subjects over the age of 60 should be able to access to adequate nutrition and appropriate nutritional services. In order to ensure healthy aging and to reduce effects of specific diseases, recommendations are needed for illness and disability in this population, as well as adequate physical activity and specific support programs, culturally accepted. The aim of this study is to evaluate eating habits in term of food consumption, health state and lifestyle in a sample of free-living elderly over the age of 65, living in Milan and surroundings. In particular, profiling of the elderly population is performed using a survey in which information are collected on methods, contexts, time and ability to buy, prepare, consume and dispose of and recycle food. Eating habits and knowledge about food are detected through the analysis of food consumption frequencies, and lifestyle by assessing the level of physical activity, quality of sleep, smoking habit. Weight status and health status are evaluated through anthropometric measurements, body composition (bioelectrical impedance) and strength test. Other information relating to social participation and other socio-demographic variables (age, gender, family composition, socio-economic status) are collected to have a completed profiling of target population. Achieved results will help us to identify factors on which acting to ensure healthy aging and counteract inflammaging, the chronic low-grade systemic inflammation characteristic in the aging process. Moreover, the study allows increasing the knowledge related to the needs and requirements of the target population to determine a good food policy and to increase the elderly empowerment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

3.4 years

First QC Date

May 15, 2020

Last Update Submit

May 28, 2021

Conditions

Keywords

elderlylife styleeating habitshealth statusbody compositionsarcopenianutritional deficiencyaged

Outcome Measures

Primary Outcomes (11)

  • Assessment of the socio-demographic characteristics

    Age, Educational level, family status, food safety, food security.

    1 day

  • Assessment of eating habits

    Eating habits: evaluated with the Food Habit (FHQ) section of questionnaire by Turconi et al. (2003), to investigate the eating habits related to daily number of meals, consumption of the main food groups (fruit, vegetables, etc) and soft drinks or alcoholic beverages. Each question has the following response: always, often, sometimes, never. The score assigned to each response ranged from 0 to 3, with the maximum score assigned to the healthiest one and the minimum score to the least healthy one according to the Italian National Dietary Guidelines (2018).

    1 day

  • Assessment of smoking habits

    Smoking habits: evaluated with specific semi-quantitative questions such as: "Are you smoker, no-smoker or former smoker?"; "How long have you been smoking?", "How old were you when you started smoking?" and "How many cigarettes do you smoke daily?" in current smokers; "How many years have passed since the last cigarette?" and "How many cigarettes per day did you use to smoke?" in former smokers. The minimum score was assigned to the healthiest habit.

    1 day

  • Assessment of Physical activity level

    Physical activity level evaluated with the International Physical Activity Questionnaires (IPAQ) - Short Form. The specific activity levels assessed are walking, moderate-intensity activities and vigorous-intensity activities. The scores are expressed in Metabolic Equivalent of task -minutes/week.The total score includes the sum of the duration (in minutes) and the frequency (days) of the three dimensions analyzed (walking, activity of moderate intensity and vigorous intensity). Higher number of MET per week relate with higher level of physical activity.

    1 day

  • Assessment of Sleep Quality

    Sleep Quality: evaluated with the Italian version of Pittsburgh Sleep Quality Index (PSQI), validated by Curcio et al (2011). It's a 19-item questionnaire investigating seven domains of sleep (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction). A global score, calculated from the score of each domains, higher than 5 is considered as an indicator of bad sleep quality.

    1 day

  • Nutritional assessment: weight status

    Measurement of: body weight in kilograms; height in centimeters, evaluated with prediction formula height-knee by Donini et al (2000); weight and height will be combined to report BMI in kg/m\^2 to evaluate the weight status (underweight, normal, overweight, obesity);

    1 day

  • Nutritional assessment: fat distribution

    Measurement of: waist circumference in centimeters; hip circumference in centimeters; waist and hip will be combined to report waist-hip ratio (WHR) and waist and height will be combined to report waist-height ratio (WHtR), both as indicators of fat distribution and metabolic diseases risk.

    1 day

  • Nutritional assessment: other antropometric parameters

    Measurement of calf circumference in centimeters, as inidcator of muscle mass. Measurement of neck circumference in centimeters, as indicator of fat distribution and metabolic diseases risk.

    1 day

  • Nutritional assessment: arm circumference and triceps skinfold thickness

    Mesurement of: arm circumference in centimeters, as inidcator of muscle mass; triceps skinfold thickness in millimeters, as indicator of fatty mass; upper arm circumference and triceps fold will be combined to report the upper arm area in millimeters\^2, upper arm muscle area in millimeters\^2, upper arm fat area in millimeters\^2.

    1 day

  • Nutritional assessment: muscle strenght

    Measurement of hand-grip in kilograms, to assess muscle strength

    1 day

  • Nutritional assessment: body composition

    Assessment of body composition with bioelectrical impedance analysis (BIVA).

    1 day

Secondary Outcomes (3)

  • Adherence to Italian National Dietary Guidelines

    1 day

  • Identify possible nutritional deficiencies

    1 day

  • Lifestyle and nutritional status

    1 day

Study Arms (1)

Free-living elderly

Free-living elderly over the age of 65 living in Metropolitan Area of Milan, in apparent good health conditions. Male and Female

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Free-living over 65 subjects living in Milan and surroundings, in apparent good health conditions and self sufficient, able to express their consent to participate in the study.

You may qualify if:

  • Age: over 65
  • free-living
  • autonomous, self sufficient
  • acceptance and sign of informed consent

You may not qualify if:

  • Age: under 65
  • living in: nursing home, Extended Care
  • hospitalized
  • non autonomous, non self sufficient
  • without acceptance and sign of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pavia

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Feeding BehaviorMalnutritionSarcopenia

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorNutrition DisordersNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Hellas Cena

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tenured researcher

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 26, 2020

Study Start

November 1, 2017

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

June 1, 2021

Record last verified: 2021-05

Locations