NCT06480669

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable diabetes

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

June 17, 2024

Last Update Submit

June 24, 2024

Conditions

DiabetesHypertensionDyslipidemiasObesity

Outcome Measures

Primary Outcomes (11)

  • Biochemical values (mg/dL)

    Basal glucose, High-Density Lipoprotein, Low-Density Lipoprotein, total cholesterol, triglycerides, serum transferrin, urea, uric acid, creatinine.

    12 weeks

  • Blood Pressure (mmHg)

    Blood pressure (Systolic blood pressure, diastolic blood pressure)

    12 weeks

  • Anthropometric values (kg)

    Weight

    12 weeks

  • Anthropometric values (cm)

    Weight, waist circumference, hip circumference.

    12 weeks

  • Anthropometric values (kg/m^2)

    Body mass index.

    12 weeks

  • Anthropometric index (numerical rating scale)

    Atherogenic index of plasma, waist/hip ratio.

    12 weeks

  • Biochemical values (IU/L)

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

    12 weeks

  • Biochemical values (mg/L)

    C-Reactive Protein

    12 weeks

  • Biochemical values (µg/L)

    Serum ferritin

    12 weeks

  • Biochemical values (µg/dL)

    Iron

    12 weeks

  • Biochemical values (g/dL)

    Albumin

    12 weeks

Study Arms (2)

Time Restricted Feeding (TRF)

EXPERIMENTAL

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

Mediterranean diet

ACTIVE COMPARATOR

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

Other: Mediterranean Diet

Interventions

Time Restricted FeedingOTHER

8 participants who practiced a 12/12 TRF (12 hours of fasting, from approximately 20:30 to 8:30 the following day).

Also known as: TRF
Time Restricted Feeding (TRF)
Mediterranean DietOTHER

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

Mediterranean diet

Eligibility Criteria

Age61 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zaragoza

Zaragoza, Spain

Location

MeSH Terms

Conditions

Diabetes MellitusHypertensionDyslipidemiasObesity

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 17, 2024

First Posted

June 28, 2024

Study Start

January 1, 2024

Primary Completion

May 15, 2024

Study Completion

June 4, 2024

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)