Ketogenic vs Mediterranean Diets for Aging

Overseen By Sanaa Badour, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Diabetes, Cancer, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Preclinical data indicate that very low carbohydrate ketogenic diets (KD) may prevent progression of age-related sarcopenia (skeletal muscle decline) but also may disturb bone metabolism. The investigators will pilot test a randomized trial comparing the effects of short-term adaptation to a well-formulated ketogenic diet and Mediterranean diet on markers of bone metabolism and muscle function in older adults. The expected results will help inform the benefit-risk assessment for older patients considering longer term use of KD therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on anti-hypertensive medication, you may still be eligible to participate.

What data supports the effectiveness of the treatment Mediterranean Diet, MedDiet, Mediterranean-style diet, Very Low Carbohydrate Ketogenic Diet, Ketogenic Diet, Very Low Carbohydrate Diet, Low-Carb High-Fat Diet?

Research shows that the Mediterranean diet can reduce hospital stays, lower medical costs, and decrease mortality in older adults. The ketogenic diet has been beneficial for weight loss, diabetes control, and cancer outcomes in older patients, although it may cause some side effects like constipation and fatigue. ^{1 2 3 4 5}

Is the Mediterranean diet generally safe for humans?

Research suggests that the Mediterranean diet is generally safe and may even reduce the risk of death and improve cardiovascular health in adults. ^{1 6 7 8 9}

How does the ketogenic and Mediterranean diet treatment for aging differ from other treatments?

The ketogenic diet is unique because it focuses on very low carbohydrate intake, which can lead to weight loss and improved glucose control, while the Mediterranean diet emphasizes a balanced intake of essential nutrients and is associated with prolonged survival, especially in older adults. Both diets offer distinct health benefits, but the Mediterranean diet is more sustainable for long-term use. ^{3 4 9 10 11}

Research Team

Cora Best, PhD, RDN

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for older adults who are postmenopausal, have had a stable weight and BMI between 20 to <35 kg/m2 over the past year. Participants must live in a permanent home, be willing to eat provided food, follow dietary advice, document their intake, maintain their current weight, own a smartphone for monitoring purposes and attend study visits.

Inclusion Criteria

I am postmenopausal.

Your weight has not changed much in the past year.

Your body mass index (BMI) must be between 20 and 35.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person), 1 at-home urine collection

Dietary Intervention

Participants are assigned to either a very low carbohydrate ketogenic diet or a Mediterranean diet for 6 weeks. Meals are provided, and participants receive continuous support from a dietitian.

6 weeks

6 visits (in-person, weekly)

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention

4 weeks

Treatment Details

Interventions

• Mediterranean Diet
• Very Low Carbohydrate Ketogenic Diet

Trial Overview The study is testing how two diets affect muscle and bone health in older adults. One group will follow a very low carbohydrate ketogenic diet while another will adhere to a Mediterranean diet. The goal is to see which diet might better prevent muscle decline or impact bone metabolism.

Participant Groups

Group I: Very low carbohydrate ketogenic diet for six weeks Experimental Treatment 1 Intervention

Group II: Mediterranean diet for six weeks Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

In a study of 183 hospitalized patients over 65 years old, adherence to the Mediterranean diet (MedDiet) was associated with a significant reduction in hospital length of stay by 0.3 days for each unit increase in MedDiet score.

Higher adherence to the MedDiet also correlated with a 13% decrease in long-term mortality risk, suggesting that this dietary pattern not only improves health outcomes but may also reduce healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mediterranean diet on hospital length of stay, medical expenses, and mortality in elderly, hospitalized patients: A 2-year observational study. Lampropoulos, CE., Konsta, M., Dradaki, V., et al.[2021]

The Mediterranean Diet (MedDiet) has been linked to numerous health benefits, particularly in reducing the risk of cardiovascular diseases, metabolic disorders, and cancer, as evidenced by an increase in clinical trials over the last decade.

The diet's positive effects are largely attributed to its anti-inflammatory and antioxidant properties, with strict adherence and specific components like olive oil playing crucial roles in managing obesity and waist circumference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mediterranean Diet: An Update of the Clinical Trials. Finicelli, M., Di Salle, A., Galderisi, U., et al.[2022]

In a study of 200 older patients (median age 70) on a ketogenic diet, 67% reported beneficial outcomes, including significant weight loss for 79% of those seeking it, improved glucose control for 54% of those with diabetes, and positive effects on cancer outcomes for 63% of patients pursuing that goal.

While the ketogenic diet showed promise for various health issues in older adults, 15% of participants experienced adverse events, including dyslipidemia and constipation, highlighting the need for careful monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can older patients adopt and maintain a ketogenic diet? An observational study in support of clinical trials in older patients. Almodallal, Y., Cook, K., Lammert, LM., et al.[2023]

The Mediterranean diet, characterized by its balanced intake of macronutrients and micronutrients, is recommended for long-term weight maintenance and health benefits, unlike short-term restrictive diets that are difficult to sustain.

Low-carbohydrate ketogenic diets may pose medical risks, particularly for individuals with obesity, as they can lead to metabolic acidosis and renal issues, potentially reducing life expectancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-carbohydrate ketogenic diets in body weight control: A recurrent plaguing issue of fad diets? Schutz, Y., Montani, JP., Dulloo, AG.[2021]

A study of 200 hospitalized patients over 60 years old revealed that 91.5% had unhealthy diets, which were linked to poor clinical outcomes like malnutrition and frailty.

Higher adherence to the Mediterranean diet was associated with shorter hospital stays and better overall health, indicating that improving dietary habits could enhance recovery in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet in Turkish hospitalized older adults and its association with hospital clinical outcomes. Ergul, F., Sackan, F., Koc, A., et al.[2022]

A Mediterranean diet supplemented with dairy foods significantly reduced systolic and diastolic blood pressure in participants at risk of cardiovascular disease, indicating improved cardiovascular health.

The MedDairy diet also led to favorable changes in cholesterol levels, including higher HDL cholesterol and lower triglycerides, suggesting it may be an effective dietary approach for managing cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mediterranean diet supplemented with dairy foods improves markers of cardiovascular risk: results from the MedDairy randomized controlled trial. Wade, AT., Davis, CR., Dyer, KA., et al.[2023]

In a study of 15,535 middle-aged Spanish university graduates followed for an average of 6.8 years, higher adherence to the Mediterranean diet was linked to a significantly lower risk of death, with hazard ratios of 0.58 for moderate adherence and 0.38 for high adherence.

Each 2-point increase in the Mediterranean Diet Score corresponded to a 28% reduction in the risk of death, suggesting that even among younger adults, following this diet can have important health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mediterranean diet is associated with a reduction in premature mortality among middle-aged adults. Martínez-González, MA., Guillén-Grima, F., De Irala, J., et al.[2023]

This study will evaluate the cardiovascular and cognitive benefits of a modified Mediterranean diet that includes 2-3 servings of fresh, lean pork per week, aiming to make the diet more sustainable for Australian populations.

The trial will involve a 24-week cross-over design with at-risk men and women, measuring various health outcomes such as blood pressure, body composition, and cognitive function, which could provide important insights for preventing cardiovascular disease and dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Including pork in the Mediterranean diet for an Australian population: Protocol for a randomised controlled trial assessing cardiovascular risk and cognitive function. Wade, AT., Davis, CR., Dyer, KA., et al.[2019]

A study on individuals over 70 years old found that following the traditional Greek variant of the Mediterranean diet is linked to a significant 17% reduction in overall mortality for each unit increase in dietary adherence score.

This suggests that a closer adherence to this diet can positively impact life expectancy in elderly populations, highlighting the potential health benefits of traditional dietary patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival beyond age 70 in relation to diet. de Groot, LC., van Staveren, WA., Burema, J.[2019]

A study of 5200 individuals aged 65 and older found that greater adherence to the Mediterranean diet (MD) is linked to a lower risk of all-cause mortality, with a 5% reduction in death risk for each one-point increase in the Mediterranean diet score (MDS).

The findings were supported by a meta-analysis of seven prospective studies, indicating that following the MD can significantly enhance survival prospects for elderly individuals, making it a beneficial dietary choice for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet and mortality in the elderly: a prospective cohort study and a meta-analysis. Bonaccio, M., Di Castelnuovo, A., Costanzo, S., et al.[2019]

A study of 330 elderly individuals (141 Anglo-Celts and 189 Greek-Australians) found that following the Mediterranean diet principles is linked to a 17% reduction in overall mortality, suggesting its potential benefits for longevity.

The positive impact of the Mediterranean diet on survival was consistent across both cultural groups, indicating its effectiveness regardless of ethnic background in a non-Mediterranean context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are the advantages of the Mediterranean diet transferable to other populations? A cohort study in Melbourne, Australia. Kouris-Blazos, A., Gnardellis, C., Wahlqvist, ML., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Mediterranean diet on hospital length of stay, medical expenses, and mortality in elderly, hospitalized patients: A 2-year observational study. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Mediterranean Diet: An Update of the Clinical Trials. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Can older patients adopt and maintain a ketogenic diet? An observational study in support of clinical trials in older patients. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Low-carbohydrate ketogenic diets in body weight control: A recurrent plaguing issue of fad diets? [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet in Turkish hospitalized older adults and its association with hospital clinical outcomes. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Mediterranean diet supplemented with dairy foods improves markers of cardiovascular risk: results from the MedDairy randomized controlled trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The Mediterranean diet is associated with a reduction in premature mortality among middle-aged adults. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Including pork in the Mediterranean diet for an Australian population: Protocol for a randomised controlled trial assessing cardiovascular risk and cognitive function. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Survival beyond age 70 in relation to diet. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Mediterranean diet and mortality in the elderly: a prospective cohort study and a meta-analysis. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Are the advantages of the Mediterranean diet transferable to other populations? A cohort study in Melbourne, Australia. [2021]