What side effects are associated with this type of intervention?

Common side effects of dietary changes emphasizing whole, plant-based foods include gastrointestinal issues such as bloating, gas, and changes in bowel habits due to increased fiber intake. Some individuals may experience initial fatigue or weakness as their bodies adjust to a lower intake of animal-based proteins and fats. Additionally, there may be a risk of nutrient deficiencies, such as vitamin B12, iron, and omega-3 fatty acids, if the diet is not well-planned. However, these side effects are generally manageable and can be mitigated with proper dietary planning and gradual adjustments.

What prior FDA approvals exist?

The FDA has approved various treatments for chronic diseases, particularly those focusing on cardiovascular health and weight loss. While specific dietary programs like the Whole Food, Plant-Based (WFPB) program are not directly approved by the FDA, the agency supports dietary guidelines that emphasize the consumption of fruits, vegetables, whole grains, and legumes. These dietary changes are known to improve cardiovascular health and aid in weight management. Additionally, the FDA has approved medications such as statins for lowering cholesterol and antihypertensive drugs for managing blood pressure, which can complement dietary interventions. Overall, the FDA endorses a combination of pharmacological treatments and lifestyle modifications, including diet, to manage chronic diseases effectively.

What other types of research exist?

Promising alternatives to a Whole Food, Plant-Based (WFPB) program for chronic disease patients include the Mediterranean diet and low-carbohydrate diets. The Mediterranean diet, which emphasizes fruits, vegetables, whole grains, nuts, and healthy fats like olive oil, has been shown to improve cardiovascular health and support weight loss. Low-carbohydrate diets, which limit carbohydrate intake and emphasize protein and fat, may also aid in weight loss and improve serum lipids, although long-term effects are still being studied.

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Behavioural Intervention

Plant-Based Diet Program for Chronic Disease

N/A

Waitlist Available

Led By Christiane L Meireles, PhD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a plant-based diet program with group medical meetings to help overweight or obese adults with chronic diseases improve their health. Participants eat mostly plants and whole foods, get regular support from healthcare professionals, and work on managing stress, sleeping better, and being more active.

Who is the study for?

This trial is for men and women over 18 who are overweight or obese, have at least one chronic disease, can use a smartphone or tablet with internet, and will follow the study rules. They must speak English.

What is being tested?

The trial tests the 'Plants-2-Plate' program which promotes whole food, plant-based nutrition through group medical appointments to see if it lowers heart risk factors and helps with weight loss in adults.

What are the potential side effects?

Since this is a nutritional program focusing on plant-based foods rather than medication, side effects may include changes in digestion or food preferences but no severe drug-related side effects are expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

C-reactive protein (HsCRP) measurement from blood test

HDL-Cholesterol from blood chemistry panel

Interleukin (IL)-18 measurement from blood test

+5 more

Secondary study objectives

Adherence to WFPB measurement

Diastolic Blood pressure measurement

Physical activity measurement

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Green Wellness Program: Plants-2-PlateExperimental Treatment1 Intervention

The Green Wellness Program:Plants-2-Plate is an established program focusing on whole food plant-based predominant eating pattern in academic primary care setting.The dietary approach includes vegetables, fruits, legumes, whole grains, seeds, nuts in small portion, elimination of all or most of animal foods, and reduction of processed foods. Participants will eat ad libitum. In addition, they will receive support to manage stress, improve quality of sleep, and increase physical activity during the SMA.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Whole Food, Plant-Based (WFPB) diet works by emphasizing the consumption of whole, plant-based foods that are high in fiber, antioxidants, and essential nutrients, while being low in saturated fats and refined sugars. This dietary approach helps reduce inflammation, improve lipid profiles, lower blood pressure, and enhance insulin sensitivity. For chronic disease patients, these mechanisms are vital as they contribute to significant reductions in cardiovascular risk factors, better weight management, and overall improved health outcomes.

Strategies and difficulties in dietary intervention in myocardial infarction patients.