DiabetesFASTMEDNCT06480669
Impact of Intermittent Fasting and Mediterranean Diet on the Physical Health of the Elderly
A study testing Time Restricted Feeding and Mediterranean Diet in people with Diabetes and Hypertension, run by Universidad de Zaragoza at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 61 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Hypertension, Dyslipidemias
- What is being tested?
- Time Restricted Feeding and Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 4 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 61 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetes, Hypertension, Dyslipidemias, Obesity
- Being tested
- Time Restricted Feeding, Mediterranean Diet
- Medical subject headings
- Diabetes Mellitus, Hypertension, Dyslipidemias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted FeedingOther
Also called TRF
8 participants who practiced a 12/12 TRF (12 hours of fasting, from approximately 20:30 to 8:30 the following day).
Mediterranean DietOther
A control group consisting of 9 participants who followed a standard Mediterranean diet.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Time Restricted Feeding |
| Mediterranean diet | Active comparator | A control group consisting of 9 participants who followed a standard Mediterranean diet. Receives: Other: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical values (mg/dL)
Basal glucose, High-Density Lipoprotein, Low-Density Lipoprotein, total cholesterol, triglycerides, serum transferrin, urea, uric acid, creatinine.
Measured: 12 weeks
Blood Pressure (mmHg)
Blood pressure (Systolic blood pressure, diastolic blood pressure)
Measured: 12 weeks
Anthropometric values (kg)
Weight
Measured: 12 weeks
Anthropometric values (cm)
Weight, waist circumference, hip circumference.
Measured: 12 weeks
Anthropometric values (kg/m^2)
Body mass index.
Measured: 12 weeks
Anthropometric index (numerical rating scale)
Atherogenic index of plasma, waist/hip ratio.
Measured: 12 weeks
Biochemical values (IU/L)
Alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase
Measured: 12 weeks
Biochemical values (mg/L)
C-Reactive Protein
Measured: 12 weeks
Biochemical values (µg/L)
Serum ferritin
Measured: 12 weeks
Biochemical values (µg/dL)
Iron
Measured: 12 weeks
Biochemical values (g/dL)
Albumin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Jan 2024
- Primary completion15 May 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Isabel Iguacel Azorín, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480669
- Sponsor's protocol ID
- PI23/610
- Acronym
- FASTMED
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intermittent Fasting and Mediterranean Diet on the Physical Health of the Elderly: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06480669
- Acronym / sponsor ID
- FASTMED / PI23/610
- Conditions
- Diabetes, Hypertension, Dyslipidemias, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Feeding (TRF) | Experimental | Other: Time Restricted Feeding8 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 | Active comparator | Other: Mediterranean DietA control group consisting of 9 participants who followed a standard Mediterranean diet. |
Who may qualify
- Ages
- 61 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted FeedingAlso: TRF8 participants who practiced a 12/12 TRF (12 hours of fasting, from approximately 20:30 to 8:30 the following day). | Other | Time Restricted Feeding (TRF) |
| Mediterranean DietA control group consisting of 9 participants who followed a standard Mediterranean diet. | Other | Mediterranean diet |
Primary outcome
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.
Blood Pressure (mmHg)
Time frame: 12 weeks
Blood pressure (Systolic blood pressure, diastolic blood pressure)
Anthropometric values (kg)
Time frame: 12 weeks
Weight
Anthropometric values (cm)
Time frame: 12 weeks
Weight, waist circumference, hip circumference.
Anthropometric values (kg/m^2)
Time frame: 12 weeks
Body mass index.
Anthropometric index (numerical rating scale)
Time frame: 12 weeks
Atherogenic index of plasma, waist/hip ratio.
Biochemical values (IU/L)
Time frame: 12 weeks
Alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase
Biochemical values (mg/L)
Time frame: 12 weeks
C-Reactive Protein
Biochemical values (µg/L)
Time frame: 12 weeks
Serum ferritin
Biochemical values (µg/dL)
Time frame: 12 weeks
Iron
Biochemical values (g/dL)
Time frame: 12 weeks
Albumin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Feeding and Mediterranean Diet in people with Diabetes and Hypertension, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical values (mg/dL) (time frame: 12 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.