Interplay Between Adherence to the Mediterranean Diet, Lipid Profile and Blood Pressure: a Comparative Survey Among Healthcare and Non-Healthcare Female Workers

Hypertension Clinical Trial

Official title:

Interplay Between Adherence to the Mediterranean Diet, Lipid Profile and Blood Pressure: a Comparative Survey Among Healthcare and Non-Healthcare Female Workers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04596358
• Other study ID #: 10/2018
• Status: Completed
• Start date: March 10, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: October 2020
• Source: University of Bari Aldo Moro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims at testing the level of adherence to the Mediterranean diet among health-workers, comparing this aspect to the extra-working physical activity, anthropometric measures and prevalence of cardiovascular, metabolic and neoplastic diseases previously diagnosed.

Description:

The study had a cross-sectional setting and included employees of both genders currently in service.

Baseline data collection was structured as follows:

• Clinical assessment and pathological history

• Anthropometric measurements;

• Haematochemical examinations;

• Screening to adherence to Med-Diet by using "MedDietScore" questionnaire

• Assessment of the Harvard Cancer Risk Index for the evaluation of risk factors, modifiable and not, of the most frequent oncological diseases in Italy (colon, lung, breast and prostate). The index provides an estimate of individual cancer risk and is not equivalent to a cancer diagnosis. In addition, the Harvard Cancer Risk Index itself can allow the doctor to advise the worker on useful measures to reduce it;

• International Physical Activity Questionnairre (IPAQ)

• Major anthropometric and haematochemical data also allow to obtain one of the most used risk indexes for cardiovascular diseases in the scientific literature the Framingham Score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Women of working age

• Level of education at least equal to Bachelor's degree

Exclusion Criteria:

• Men

• Women under 20 years old or over 65 years old

Related Conditions & MeSH terms

• Diet Habit
• Hypercholesterolemia
• Hypertension

Intervention

Other:
• Observational
Evaluation of adherence to the Mediterranean diet through the administration of the Med Diet Score questionnaire.

Locations

Country	Name	City	State
Italy	Antonella Pipoli	Bari	Puglia

Sponsors (2)

Lead Sponsor	Collaborator
University of Bari Aldo Moro	Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Country where clinical trial is conducted

Italy, 

References & Publications (5)

D'Alessandro A, De Pergola G. Mediterranean diet pyramid: a proposal for Italian people. Nutrients. 2014 Oct 16;6(10):4302-16. doi: 10.3390/nu6104302. Review. — View Citation

Di Lorenzo L, Pipoli A, Manghisi NM, Clodoveo ML, Corbo F, De Pergola G, Sabbà C. Nutritional hazard analysis and critical control points at work (NACCPW): interdisciplinary assessment of subjective and metabolic work-related risk of the workers and their prevention. Int J Food Sci Nutr. 2020 Nov;71(7):902-908. doi: 10.1080/09637486.2020.1750572. Epub 2020 Apr 7. — View Citation

Juárez-Pérez CA, Aguilar-Madrid G, Haro-García LC, Gopar-Nieto R, Cabello-López A, Jiménez-Ramírez C, Aguado A, Martínez-Méndez LM, Chávez-Negrete A. Increased Cardiovascular Risk Using Atherogenic Index Measurement Among Healthcare Workers. Arch Med Res. 2015 Apr;46(3):233-9. doi: 10.1016/j.arcmed.2015.03.002. Epub 2015 Mar 19. — View Citation

Menotti A, Kromhout D, Blackburn H, Fidanza F, Buzina R, Nissinen A. Food intake patterns and 25-year mortality from coronary heart disease: cross-cultural correlations in the Seven Countries Study. The Seven Countries Study Research Group. Eur J Epidemiol. 1999 Jul;15(6):507-15. — View Citation

Panagiotakos DB, Pitsavos C, Stefanadis C. Dietary patterns: a Mediterranean diet score and its relation to clinical and biological markers of cardiovascular disease risk. Nutr Metab Cardiovasc Dis. 2006 Dec;16(8):559-68. Epub 2006 Feb 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the Mediterranean diet greater control of circulating lipid levels	Score of adherence (points)	at Baseline
Secondary	Fasting plasma glucose	Fasting plasma glucose in mg/dl	Baseline
Secondary	Serum insulin	Serum insulin microU/ml	Baseline
Secondary	systolic blood pressure	systolic blood pressure (mmHg)	Baseline
Secondary	diastolic blood pressure	diastolic blood pressure (mmHg)	Baseline
Secondary	Waist circumference	Waist circumference in centimeters	Baseline
Secondary	BMI (Body Mass Index)	BMI in kilograms/(meters)2	Baseline
Secondary	LDL-Cholesterol	LDL-Cholesterol in mg/dl	Baseline
Secondary	Triglycerides	Triglyceridesin mg/dl	Baseline