Diet and Exercise for High Blood Pressure

(MAT Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Daniel O Clark, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

Must not be taking: Donepezil, Memantine, Rivastigmine, Galantamine

Disqualifiers: Dementia, Cancer, Psychosis, Hypertensive heart disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this randomized controlled trial is to determine the impact of Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) diet and aerobic training on cognition in Black adults with high systolic blood pressure. Researchers will compare Food Delivery and Cooking PLUS Aerobic Training (FoRKS+) versus Enhanced Usual Care (EUC) to evaluate the effects on cognition. Participants will complete cognitive and cardiovascular assessments, 24-hr blood pressure monitoring, standard blood pressure measurements, weight, fingerstick for HbA1c point-of-care testing, and questionnaires. Participants may also choose to participate in an optional blood draw for DNA Repair Capacity testing as a modifiable risk factor for aging-associated diseases.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have been prescribed certain medications for cognitive issues. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment MIND Foods and Aerobic Training for high blood pressure?

Research suggests that the MIND diet, which is part of the treatment, may help protect against heart-related conditions and risk factors like obesity and unhealthy cholesterol levels. This implies it could be beneficial for managing high blood pressure. ^{1 2 3 4 5}

Is the MIND diet safe for humans?

The MIND diet, which combines elements of the Mediterranean and DASH diets, has been studied for its effects on brain health and cardiometabolic diseases, and no significant safety concerns have been reported in these studies. ^{1 2 6 7 8}

How is the MIND Foods and Aerobic Training treatment different from other treatments for high blood pressure?

The MIND Foods and Aerobic Training treatment is unique because it combines the MIND diet, which is a blend of the Mediterranean and DASH diets, with aerobic exercise to potentially lower blood pressure and improve heart and mental health. This approach is novel as it targets both dietary and physical activity aspects, unlike many treatments that focus solely on medication or diet. ^{1 2 4 9 10}

Research Team

Daniel O Clark, PhD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for Black adults aged 35-75 living in Marion County with high blood pressure, who are physically inactive, have stable housing with a kitchen, and can see/read street signs. They must be fluent in English and independent in daily activities. Those with normal cognition scores are eligible.

Inclusion Criteria

I can do most daily activities by myself.

You can see and read street signs (according to your own statement).

You have a stable place to live with your own kitchen that has a stove or hotplate, oven, refrigerator, and freezer.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete cognitive and cardiovascular assessments, blood pressure, weight, HbA1c testing, questionnaires, 24-hour ambulatory blood pressure, and optional blood draw

1 week

1 visit (in-person)

Treatment

Participants receive either Enhanced Usual Care (EUC) or Food Delivery and Cooking PLUS Aerobic Training (FoRKS+). EUC includes a 5-week Hypertension Self-Management Education and Support (SMES) class. FoRKS+ includes the same SMES class plus 11 weeks of MIND diet ingredient kits and virtual cooking classes, and 12 weeks of aerobic training

28 weeks

Weekly virtual sessions

Mid-Intervention Assessment

Assessments completed at mid-intervention around Week 16

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at Week 28 and Week 52

24 weeks

2 visits (in-person)

Treatment Details

Interventions

• MIND Foods and Aerobic Training (Behavioural Intervention)

Trial Overview The study tests the MIND diet combined with aerobic exercise (FoRKS+) against Enhanced Usual Care (EUC) to see which is better at improving brain function in participants. It includes cognitive assessments, blood pressure monitoring, weight checks, diabetes screening via fingerstick test, and optional DNA testing.

Participant Groups

Group I: Food Delivery and Cooking PLUS Aerobic Training (FoRKS+) Experimental Treatment 1 Intervention

Participants randomized to FoRKS+ will attend weekly HTN SMES classes separately from EUC participants. SMES classes will include the EUC curriculum stated above and an introduction to the upcoming FoRKS+ intervention. Following HTN SMES completion, FoRKS+ continues with home-delivered Mediterranean-style ingredient kits, food management lessons, and hands-on cooking classes in one's own kitchen. Classes are led by registered dietitians via Webex. Classes are held twice per week thru Week 12, then only once per week through Week 16. Intervention continues with aerobic exercise led by health coaches via Webex. Classes start in Week 13 with one session per week, increasing to two sessions per week in Weeks 17-28.

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

Participants randomized to EUC will have access to existing usual primary care services. They will also be enrolled in Hypertension Self-Management Education and Support (SMES) class ("Hypertension group"), which is an existing CDC-endorsed program offered at Eskenazi Health to provide information and skills for managing hypertension (HTN). Classes are led by registered dietitians via Webex.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Alan Palkowitz

Indiana University

Chief Executive Officer since 2020

PhD in Chemistry from Indiana University

David Ingram

Indiana University

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

Adherence to the MIND diet is associated with a significantly reduced risk of developing multiple sclerosis (MS), with an adjusted odds ratio of 0.10, indicating a strong protective effect based on a study of 77 patients with relapsing-remitting MS and 148 healthy controls.

Specific components of the MIND diet, such as high consumption of green leafy vegetables, other vegetables, and beans, are linked to lower odds of MS, while higher intake of unhealthy foods like pastries, sweets, and fried foods is associated with increased odds of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MIND Diet Adherence Might be Associated with a Reduced Odds of Multiple Sclerosis: Results from a Case-Control Study. Noormohammadi, M., Ghorbani, Z., Naser Moghadasi, A., et al.[2022]

The MIND diet is associated with improvements in various cardiometabolic outcomes, including better blood pressure, glycemic control, and lipid profiles, based on a systematic review of 23 studies involving adults.

The evidence supports the MIND diet as a beneficial strategy for reducing cardiometabolic risk, although more long-term and well-designed studies are needed to confirm its effects on cardiovascular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of the MIND Diet with Cardiometabolic Diseases and Their Risk Factors: A Systematic Review. Akbar, Z., Fituri, S., Ouagueni, A., et al.[2023]

In a study of 2,598 older adults, those who adhered more closely to the MIND dietary pattern showed significantly better cognitive performance, particularly in tests related to memory and global cognition.

While both MIND and Mediterranean-like diets were associated with improved cognitive scores, the MIND diet demonstrated stronger positive correlations with cognitive performance compared to the Mediterranean Eating Pattern for Americans (MEPA III).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive performance in relation to MIND and MEPA III dietary pattern accordance of NHANES participants. Derdiger, S., Friedeborn, S., Tangney, CC.[2023]

In a 3-year randomized controlled trial involving 604 older adults at risk for dementia, the MIND diet did not show significant cognitive benefits compared to a control diet, with only a slight improvement in global cognition scores for the MIND diet group.

MRI results indicated no significant differences in brain characteristics, such as white-matter hyperintensities and hippocampal volumes, between participants following the MIND diet and those on the control diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons. Barnes, LL., Dhana, K., Liu, X., et al.[2023]

In a study of 339 individuals with obesity, those who adhered more closely to the MIND diet showed lower levels of stress and higher insulin sensitivity, suggesting potential mental health and metabolic benefits.

The highest MIND diet scores were linked to increased intake of brain-healthy foods and a significant reduction in the consumption of unhealthy sweets and pastries, indicating a positive dietary shift.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the association between the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet, mental health, and cardio-metabolic risk factors among individuals with obesity. Ardekani, AM., Vahdat, S., Hojati, A., et al.[2023]

A review of recent randomized controlled trials (RCTs) found that chronic intake of whole foods from Mediterranean, DASH, MIND, and ketogenic diets generally supports improvements in cognitive function, with 26 out of 29 studies showing positive results.

Despite variations in study design and small sample sizes, the evidence suggests that these dietary patterns can be an effective nonpharmacological approach to enhance cognitive health in middle-aged and older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Dietary Intake Through Whole Foods on Cognitive Function: Review of Randomized Controlled Trials. Jiwani, R., Robbins, R., Neri, A., et al.[2022]

In a study of 72 older Chinese patients with hypertension, both the MIND diet and the combination of the MIND diet with forest bathing showed a tendency to lower systolic blood pressure, although no significant differences were found between the groups after four weeks.

Participants in the MIND-FB group experienced significant reductions in total cholesterol, LDL cholesterol, triglycerides, and glucose levels, along with lower anxiety and negative mood states, suggesting that this combined approach may enhance both cardiac and mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac and Mental Benefits of Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet plus Forest Bathing (FB) versus MIND Diet among Older Chinese Adults: A Randomized Controlled Pilot Study. Yau, KY., Law, PS., Wong, CN.[2023]

Adhering to the MIND diet is associated with a significantly lower prevalence of hypertension and reduced systolic blood pressure among participants, indicating its potential as an effective dietary approach for managing blood pressure.

In hypertensive patients, those following the MIND diet had a lower risk of all-cause mortality and cardiovascular death over a 10-year follow-up, suggesting that this diet may improve long-term health outcomes for individuals with high blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of the MIND diet in the primary and secondary prevention of hypertension: A cross-sectional and longitudinal cohort study from NHANES analysis. Song, Y., Chang, Z., Cui, K., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

MIND Diet Adherence Might be Associated with a Reduced Odds of Multiple Sclerosis: Results from a Case-Control Study. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Associations of the MIND Diet with Cardiometabolic Diseases and Their Risk Factors: A Systematic Review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Cognitive performance in relation to MIND and MEPA III dietary pattern accordance of NHANES participants. [2023]

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

Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Roles of physical activity and diet in cognitive aging: is more better? [2023]

6. England pubmed.ncbi.nlm.nih.gov

Evaluating the association between the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet, mental health, and cardio-metabolic risk factors among individuals with obesity. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Adherence to the MIND diet is associated with 12-year all-cause mortality in older adults. [2022]

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

Effect of Dietary Intake Through Whole Foods on Cognitive Function: Review of Randomized Controlled Trials. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Cardiac and Mental Benefits of Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet plus Forest Bathing (FB) versus MIND Diet among Older Chinese Adults: A Randomized Controlled Pilot Study. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The value of the MIND diet in the primary and secondary prevention of hypertension: A cross-sectional and longitudinal cohort study from NHANES analysis. [2023]