Diet and Exercise for High Blood Pressure

(MAT Trial)

Overseen By Lyndsi R Moser, BA, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

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

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

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

Compensation: Varies

Number of Visits: 5

Duration: 28 weeks

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special diet and exercise routine, called MIND Foods and Aerobic Training, can enhance brain health in Black adults with high blood pressure. Researchers will compare two groups: one receiving food delivery, cooking classes, and exercise, and the other receiving enhanced usual care. They seek participants with a systolic blood pressure of 130 or higher who are willing to cook at home and exercise. Participants will undergo various health assessments, including blood pressure and cognitive tests. Optional DNA testing is available to explore risks related to aging-related diseases. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve brain health and manage high blood pressure.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the MIND diet, a component of the MIND Foods and Aerobic Training program, is generally safe and easy to follow. This diet includes healthy foods like leafy greens, berries, nuts, and whole grains, all recognized for their health benefits. No major reports of negative effects have emerged from following this diet.

Aerobic exercise, also part of the program, is widely considered safe when performed correctly. Studies combining the MIND diet with exercise have demonstrated improvements in cognitive and physical abilities without major safety issues.

While specific safety details for this combination in the current trial aren't provided, both the diet and exercise are known to promote good health. Participants can rely on existing evidence supporting the safety of these components. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FoRKS+ program because it combines a Mediterranean-style diet with guided cooking lessons and aerobic exercise, offering a holistic approach to managing high blood pressure. Unlike standard care, which often involves medication and basic lifestyle advice, this program provides personalized food delivery and hands-on virtual cooking classes led by dietitians. Additionally, the integration of regular aerobic training with health coaches distinguishes it from other lifestyle interventions, potentially leading to more sustainable health improvements.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

This trial will compare two approaches for managing high blood pressure. One group of participants will follow the MIND Foods and Aerobic Training program, which combines the MIND diet and aerobic exercise. Research has shown that the MIND diet, which merges elements of the Mediterranean and DASH diets, links to better brain health. Studies have found that people who closely follow the MIND diet often experience slower memory loss and have a lower risk of Alzheimer's disease. The diet emphasizes foods like berries and leafy greens, known to boost brain health. Additionally, aerobic exercise improves heart health and brain function. Together, the MIND diet and aerobic exercise may enhance thinking skills in adults with high blood pressure. ^{1 2 6 7 8}

Who Is on the Research Team?

Daniel O Clark, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• MIND Foods and Aerobic Training

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.

How Is the Trial Designed?

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+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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 132 healthy adults aged 52-91, adherence to the MIND diet and physical activity were both linked to better executive functioning and increased grey matter volume, especially when one of the two was low.

The results suggest that while both the MIND diet and physical activity independently contribute to cognitive health, combining them does not necessarily lead to significantly better outcomes than either alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Roles of physical activity and diet in cognitive aging: is more better? E Escher, C., Asken, BM., VandeBunte, A., et al.[2023]

In a study of 882 older adults over 12 years, adherence to the MIND diet was linked to a 12% reduction in all-cause mortality risk for each unit increase in diet score, indicating its potential health benefits.

Participants with the highest adherence to the MIND diet had a 37% lower risk of death compared to those with the lowest adherence, suggesting that this dietary pattern may be a valuable public health recommendation for increasing longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8042655/

Mediterranean-DASH Intervention for Neurodegenerative ... Previous observational studies showed that greater adherence to the MIND diet was related to a lower risk of AD [31, 32] and slower cognitive decline [33].

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7199507/

Mediterranean-Dash Intervention for Neurodegenerative ... This study sought to determine if the MIND diet (a hybrid of the Mediterranean and Dash diets, with modifications based on the science of nutrition and the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2161831324000188

Review The Mediterranean-Dietary Approaches to Stop ... The MIND diet is a hybrid of the Mediterranean and DASH diets and further emphasizes intake of food groups with neuroprotective properties, including berries ...

4. ejnpn.springeropen.com ejnpn.springeropen.com/articles/10.1186/s41983-023-00752-1

Examining the efficacy of the Mediterranean-DASH diet ... The review reveals consistent evidence suggesting a positive association between adherence to the MIND diet and improved cognitive performance.

5. mdpi.com mdpi.com/2072-6643/16/15/2458

The Mediterranean-DASH Intervention for ... MIND is a hybrid of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets, and its association with renal outcomes remains unclear.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06152614/mind-foods-and-aerobic-training-in-black-adults-with-htn?activelyRecruiting=false&page=261&id=312&slug=dementia

MIND Foods and Aerobic Training in Black Adults With HTN The goal of this randomized controlled trial is to determine the impact of Mediterranean-Dash Intervention for Neurodegenerative Delay ...

7. researchgate.net researchgate.net/publication/359727145_Aerobic_Exercise_with_Mediterranean-DASH_Intervention_for_Neurodegenerative_Delay_Diet_Promotes_Brain_Cells'_Longevity_despite_Sex_Hormone_Deficiency_in_Postmenopausal_Women_A_Randomized_Controlled_Tr

Aerobic Exercise with Mediterranean-DASH Intervention ... Conclusion: Aerobic exercise combined with the MIND diet improves cognitive and functional levels and substitutes sex hormones deficiency in ...

8. mdpi.com mdpi.com/2072-6643/17/15/2548

Mediterranean-DASH Intervention for Neurodegenerative ... MIND emphasizes consuming green leafy vegetables, berries, nuts, beans, whole grains, seafood, poultry, olive oil, wine, and limited intake of animal and high- ...