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Completed

NCT Number: NCT06480669

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

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.

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Key information

Conditions

Diabetes Body Weight Cardiovascular Diseases Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

61 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zaragoza

Zaragoza, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Time Restricted Feeding

Other

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

Mediterranean Diet

Other

A control group consisting of 9 participants who followed a standard Mediterranean diet.

Primary outcomes

  1. 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.

  2. Blood Pressure (mmHg)

    Time frame: 12 weeks

    Blood pressure (Systolic blood pressure, diastolic blood pressure)

  3. Anthropometric values (kg)

    Time frame: 12 weeks

    Weight

  4. Anthropometric values (cm)

    Time frame: 12 weeks

    Weight, waist circumference, hip circumference.

  5. Anthropometric values (kg/m^2)

    Time frame: 12 weeks

    Body mass index.

  6. Anthropometric index (numerical rating scale)

    Time frame: 12 weeks

    Atherogenic index of plasma, waist/hip ratio.

  7. Biochemical values (IU/L)

    Time frame: 12 weeks

    Alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase

  8. Biochemical values (mg/L)

    Time frame: 12 weeks

    C-Reactive Protein

  9. Biochemical values (µg/L)

    Time frame: 12 weeks

    Serum ferritin

  10. Biochemical values (µg/dL)

    Time frame: 12 weeks

    Iron

  11. Biochemical values (g/dL)

    Time frame: 12 weeks

    Albumin

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study title

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

Acronym: FASTMED

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2024
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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