What side effects are associated with this type of intervention?

Common treatments for health behaviors, particularly dietary modifications, include low-carbohydrate diets, low-fat diets, and Mediterranean diets. Known side effects of low-carbohydrate diets can include constipation, headache, halitosis (bad breath), muscle cramps, and general weakness. Low-fat diets may lead to deficiencies in essential fatty acids and fat-soluble vitamins if not properly balanced. Mediterranean diets are generally well-tolerated but may cause gastrointestinal discomfort in some individuals due to high fiber content. It is important to tailor dietary interventions to individual needs and monitor for any adverse effects.

What prior FDA approvals exist?

The FDA has approved various treatments aimed at modifying health behaviors, particularly in the context of dietary interventions. While specific drugs targeting dietary modifications for physical performance are not explicitly detailed, the FDA has approved medications for weight management and obesity, such as orlistat and liraglutide, which indirectly influence dietary habits and physical health. These approvals highlight the regulatory focus on interventions that can modify health behaviors through nutritional and lifestyle changes.

What other types of research exist?

Promising, novel alternatives to dietary modification for improving physical performance and health behaviors in 2024 include personalized nutrition plans using new dietary assessment methods, integration of physical activity with dietary changes, and the use of technology such as mobile applications and internet-based programs for dietary adherence and lifestyle interventions. Additionally, behavioral therapy and group support programs can enhance the effectiveness of these strategies.

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Diet Comparison for Athletic Performance

N/A

Waitlist Available

Led By Christopher D Gardner, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4 or week 6

Awards & highlights

No Placebo-Only Group

Summary

This trial compares plant-based diets with an animal meat diet to see how they affect athletic performance in healthy undergraduate athletes, especially focusing on BIPOC students. It aims to understand how these diets influence endurance and strength and to identify any cultural barriers to adopting plant-based diets.

Who is the study for?

This trial is for healthy, recreational athletes aged 18-35 with a BMI of 18.5-30 who run or lift weights regularly (3-4 times per week) and have been doing so consistently for the past year. They must eat meat daily, be on a Stanford meal plan, and not be pregnant or planning to compete in physical competitions soon.

What is being tested?

The study compares the effects of three diets on athletic performance: an omnivorous diet (Animal), a whole food plant-based diet (WFPB), and a diet including plant-based meat alternatives (PBMA). Participants will alternate between these diets while maintaining their regular exercise routines.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include digestive adjustments to new foods, potential nutrient deficiencies if not balanced correctly, and individual reactions to different types of proteins.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4 or week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4 or week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4 or week 6 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Composite Machine Strength Index (Resistance Trainers)

Cooper 12-Minute Timed Run Test (Runners)

Secondary study objectives

Diet satisfaction

Dietary intake and adherence

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: Plant-Based Meat Alternatives (PBMA)Experimental Treatment2 Interventions

Up to 2 servings per day of plant-based meat alternatives (Beyond Beef, Impossible Burger, Gardein Chick'n) OR as many plant-based meat alternative servings as available per day in the dining halls.

Group II: AnimalExperimental Treatment2 Interventions

2 servings/day of traditional meat products (beef burger, pork, chicken)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diet order: Animal, PBMA

2023

N/A

~50

Diet order: PBMA, Animal

2023

N/A

~50

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

Common treatments for health behaviors, particularly through dietary modifications, work by altering the intake of macronutrients such as fats, carbohydrates, and proteins. For example, low-carbohydrate diets can improve insulin sensitivity and promote weight loss, while Mediterranean diets, rich in healthy fats and vegetables, can reduce inflammation and improve cardiovascular health. These mechanisms are important for patients as they help in selecting the most suitable dietary strategy based on individual health goals, preferences, and metabolic responses, ultimately enhancing adherence and long-term health outcomes.

Nutritional recommendations for patients undergoing prolonged glucocorticoid therapy.