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

Not Applicable

Completed

• Conditions: Diabetes; Hypertension; Obesity; Dyslipidemias
• Interventions: Other: Time Restricted Feeding; Other: Mediterranean Diet

• Registration Number: NCT06480669
• Lead Sponsor: Universidad de Zaragoza

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-05-15
• Status Verified: 2024-06
• Study Completion: 2024-06-04
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Study First Posted: 2024-06-28
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Time Restricted Feeding (TRF)	Time Restricted Feeding	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).
Mediterranean diet	Mediterranean Diet	A control group consisting of 9 participants who followed a standard Mediterranean diet.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Zaragoza; 🇪🇸 Zaragoza, Spain