Impact of Intermittent Fasting and Mediterranean Diet on the Physical Health of the Elderly (FASTMED)

June 24, 2024 updated by: María Isabel Iguacel Azorín, Universidad de Zaragoza

Impact of Intermittent Fasting and Mediterranean Diet on the Physical Health of the Elderly: A Randomized Controlled Trial

The prevalence of chronic diseases is increasing globally. In recent years, intermittent fasting has emerged as an effective dietary pattern against some of the most common chronic diseases in the elderly, alongside the Mediterranean diet.

The objective was to determine whether a 12-hour daily intermittent fasting regimen combined with a Mediterranean diet can improve analytical and anthropometric values in the elderly.

A total of 17 individuals of both sexes, over 60 years old, autonomous, and with preserved cognitive capacity participated. They were randomly divided into two groups: 8 people in the intervention group performed intermittent fasting along with a Mediterranean diet, and 9 in the control group adopted only a Mediterranean diet. The intervention lasted 3 months, with measurements taken at the beginning and end of the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain
        • University of Zaragoza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Over 60 years of age.
  • Belong to the Bombarda health centre.
  • Preserved cognitive capacity.
  • Autonomy for basic and instrumental activities of daily living.
  • Ability to follow a TRF and/or adopt a Mediterranean dietary pattern.

Exclusion Criteria:

  • Underweight (BMI <18.5).
  • Serious or chronic uncontrolled disease.
  • Specific treatment that could alter blood and/or anthropometric values.
  • Poorly controlled type 1 or type 2 insulin-dependent diabetes mellitus.
  • Present or past episode of eating disorder (ED).
  • High alcohol consumption.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Time Restricted Feeding (TRF)
8 participants who followed a 12/12 Time Restricted Feeding (12 consecutive hours of fasting, from 20:30 to approximately 8:30 the following day).
Other: Time Restricted Feeding
8 participants who practiced a 12/12 TRF (12 hours of fasting, from approximately 20:30 to 8:30 the following day).
Other Names:
  • TRF
Active Comparator: Mediterranean diet
A control group consisting of 9 participants who followed a standard Mediterranean diet.
Other: Mediterranean Diet
A control group consisting of 9 participants who followed a standard Mediterranean diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical values (mg/dL)
Time Frame: 12 weeks
Basal glucose, High-Density Lipoprotein, Low-Density Lipoprotein, total cholesterol, triglycerides, serum transferrin, urea, uric acid, creatinine.
12 weeks
Blood Pressure (mmHg)
Time Frame: 12 weeks
Blood pressure (Systolic blood pressure, diastolic blood pressure)
12 weeks
Anthropometric values (kg)
Time Frame: 12 weeks
Weight
12 weeks
Anthropometric values (cm)
Time Frame: 12 weeks
Weight, waist circumference, hip circumference.
12 weeks
Anthropometric values (kg/m^2)
Time Frame: 12 weeks
Body mass index.
12 weeks
Anthropometric index (numerical rating scale)
Time Frame: 12 weeks
Atherogenic index of plasma, waist/hip ratio.
12 weeks
Biochemical values (IU/L)
Time Frame: 12 weeks
Alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase
12 weeks
Biochemical values (mg/L)
Time Frame: 12 weeks
C-Reactive Protein
12 weeks
Biochemical values (µg/L)
Time Frame: 12 weeks
Serum ferritin
12 weeks
Biochemical values (µg/dL)
Time Frame: 12 weeks
Iron
12 weeks
Biochemical values (g/dL)
Time Frame: 12 weeks
Albumin
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Zaragoza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

June 4, 2024

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI23/610

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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