What is the mechanism of action of this treatment?

A pulse-protein-based diet, which is naturally low in methionine (Met) and trimethylamine N-oxide (TMAO) production, offers several mechanisms of action that contribute to a healthy lifestyle. Pulses are rich in micronutrients and dietary fibers, which help stimulate the gut microbiome, leading to beneficial metabolic and anti-inflammatory adaptations. This diet can improve glycemic control, enhance body composition, and increase immunometabolic flexibility, thereby reducing the risk of chronic diseases and promoting longevity. These mechanisms are particularly important for patients aiming to maintain a healthy lifestyle, as they address both nutritional needs and long-term health outcomes.

What side effects are associated with this type of intervention?

Plant-based diets, particularly those rich in pulses and low in methionine and TMAO production, are generally well-tolerated and associated with several health benefits, including improved glycemic control and reduced risk of chronic diseases. However, some individuals may experience gastrointestinal discomfort, such as bloating and gas, due to the high fiber content. 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-balanced. It is important to monitor these potential side effects and adjust the diet accordingly under the guidance of a healthcare professional.

What prior FDA approvals exist?

The FDA has approved various dietary supplements and nutritional guidelines aimed at promoting a healthy lifestyle. While specific FDA approvals for pulse-protein-based diets are not detailed, the agency has endorsed dietary patterns that emphasize plant-based proteins, which are naturally low in methionine and TMAO production. These include recommendations for increased intake of pulses, legumes, and other plant-based foods to improve metabolic health and reduce the risk of chronic diseases. Additionally, the FDA supports the use of certain nutritional supplements, such as omega-3 fatty acids, which have been shown to improve metabolic markers and overall health.

What other types of research exist?

Promising alternatives to a pulse-protein-based diet include: 1) Mankai (Wolffia globosa) plant-based protein, which is rich in bioactive vitamin B12 and well-absorbed in humans, 2) Mediterranean diet variations, particularly those incorporating green Mediterranean elements with low meat intake, and 3) diets rich in omega-3 fatty acids, such as those including fish oil, which have shown benefits in reducing inflammation and supporting metabolic health.

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Pulse-Based Diet for Healthy Lifestyle (PRODMED1 Trial)

N/A

Waitlist Available

Led By Moul Dey, Ph.D.

Research Sponsored by South Dakota State University

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 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a plant-based diet rich in pulses to help older adults maintain muscle mass and improve health. The diet is low in certain compounds that can cause health issues, aiming to improve blood sugar levels, body composition, and overall health by supporting a healthy gut.

Who is the study for?

This trial is for people aged 60 or older, weighing at least 110 lbs, with normal HbA1C levels indicating generally good health. Participants should be currently following a meat-based diet without special dietary requirements and willing to eat on-site meals and provide samples. All races and sexes are welcome.

What is being tested?

The study tests the effects of a pulse-protein-based diet compared to a traditional meat-based diet on various health markers in older adults. It aims to see if this plant-based diet can improve long-term health outcomes by analyzing around 500 different biomarkers.

What are the potential side effects?

Since the intervention involves dietary changes, side effects may include digestive adjustments such as bloating or gas when introducing pulses into the diet. However, no specific side effects are listed as it's based on healthy lifestyle changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Concentration of TMAO in blood

Fasting blood glucose concentration in blood

Frequency of sit/stand using Chair rise test

Secondary study objectives

Balance assessment using balance and gait score

Blood pressure in mm Hg

Body weight in kilograms

+16 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pulse basedExperimental Treatment1 Intervention

Pulse-protein-based dietary intervention

Group II: Meat basedExperimental Treatment1 Intervention

Animal protein-based dietary intervention

Do I qualify?Apply below to find out

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

A pulse-protein-based diet, which is naturally low in methionine (Met) and trimethylamine N-oxide (TMAO) production, offers several mechanisms of action that contribute to a healthy lifestyle. Pulses are rich in micronutrients and dietary fibers, which help stimulate the gut microbiome, leading to beneficial metabolic and anti-inflammatory adaptations. This diet can improve glycemic control, enhance body composition, and increase immunometabolic flexibility, thereby reducing the risk of chronic diseases and promoting longevity. These mechanisms are particularly important for patients aiming to maintain a healthy lifestyle, as they address both nutritional needs and long-term health outcomes.

Increased protein intake derived from leucine-enriched protein enhances the integrated myofibrillar protein synthetic response to short-term resistance training in untrained men and women: a 4-day randomized controlled trial.High protein prescription in methylmalonic and propionic acidemia patients and its negative association with long-term outcome.Improved recovery from skeletal muscle damage is largely unexplained by myofibrillar protein synthesis or inflammatory and regenerative gene expression pathways.