Peanuts for Dietary Changes

Overseen By Abigail Raffner, PhD, RD, LD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ian J. Neeland, MD

Must be taking: GLP-1 medicines

Disqualifiers: Nut allergy, Pregnant, Incarcerated, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how daily peanut consumption affects weight, diet, and overall well-being in individuals who have used GLP-1 medications like semaglutide or tirzepatide for at least three months. Researchers aim to determine if adding peanuts to meals for 12 weeks helps participants feel fuller, have more energy, and improve body health. The trial includes two groups: one will consume 2 ounces of peanuts daily, while the other will exclude peanuts from their diet. Adults with a BMI of 30 or higher who currently use GLP-1 medications are suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding dietary impacts on health while using GLP-1 medications.

Do I have to stop taking my current medications for the trial?

The trial does not require you to stop taking your current medications. In fact, you need to continue using semaglutide or tirzepatide for at least 6 months to participate.

Is there any evidence suggesting that eating peanuts daily is safe for participants?

Research has shown that peanuts are generally safe to eat and offer many health benefits. They are rich in protein, fiber, vitamins, and minerals. Studies have found that eating peanuts can aid in weight loss and may reduce the risk of diseases like cancer and heart issues. However, some people are allergic to peanuts, which can cause serious reactions. For those without allergies, adding peanuts to the diet is usually safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike conventional dietary interventions that often involve restrictive meal plans or supplements, this treatment focuses on incorporating peanuts, a natural food source, into the daily diet. Peanuts are unique because they are rich in healthy fats, protein, and various essential nutrients, which can support overall health in a balanced way. Researchers are excited about this approach because it offers an easy and enjoyable way to make dietary changes without the need for major lifestyle overhauls or synthetic supplements. Additionally, the simplicity and accessibility of peanuts make them a practical option for many people looking to improve their diet.

What evidence suggests that eating peanuts might be an effective treatment for improving diet and health markers?

Studies have shown that eating peanuts regularly can benefit health. Peanuts contain nutrients that may help reduce cholesterol, benefiting the heart. Research indicates that diets including nuts, such as peanuts, are linked to a lower risk of heart disease. Evidence also suggests that peanuts can improve the balance of fats in the blood. Some studies even suggest that eating peanuts might help extend life by lowering the risk of heart problems. In this trial, participants in the Peanut Group will add 2 ounces of peanuts to their regular diet each day, while those in the No Peanut Group will maintain their regular diet without peanuts. Adding peanuts to a diet could help increase fullness, boost energy, and improve overall health. ^{1 6 7 8 9}

Who Is on the Research Team?

Ian Neeland, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Abigail Raffner, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

Adults with obesity (BMI ≥30 kg/m2) who are taking GLP-1 medications like semaglutide or tirzepatide for at least three months and plan to continue for six more. Not suitable for those allergic to nuts, pregnant or breastfeeding women, incarcerated individuals, or anyone not using GLP-1 drugs due to contraindications.

Inclusion Criteria

I have a BMI of 30 or higher and plan to use semaglutide or tirzepatide for at least 6 months.

Exclusion Criteria

I have not used and cannot use GLP-1 RA medication.

Pregnant or breastfeeding

Incarcerated

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume 2 ounces of peanuts daily for 12 weeks to assess effects on satiety, fatigue, mood, dietary quality, food enjoyment, and physical activity

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Peanuts

Trial Overview The trial is testing the effects of daily peanut consumption on weight management, diet healthiness, energy levels, and body composition over 12 weeks. Participants' feelings of fullness and certain blood markers will also be monitored using DEXA scans.

How Is the Trial Designed?

Group I: Peanut Group Experimental Treatment 2 Interventions

Participants in this group will eat 2 ounces, or 53 grams of dry-roasted, lightly salted (low sodium) each day along with their regular diet.

Group II: No Peanut Group Active Control 1 Intervention

Participants in this group will continue eating regular diet without peanuts.

Who Is Running the Clinical Trial?

Ian J. Neeland, MD

Lead Sponsor

Trials

2

Recruited

280+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4711439/

Peanuts as functional food: a review - PMC Peanuts are excellent source of compounds like resveratrol, phenolic acids, flavonoids and phytosterols that block the absorption of cholesterol from diet.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622099424

Impact of Peanuts and Tree Nuts on Body Weight and ... In 1 early trial (26), peanuts provided 95% of the energy from fat to 10 participants adhering to a vegetarian diet for 6 d. With whole nuts, 17.8% of the lipid ...

3. ffhdj.com ffhdj.com/index.php/ffhd/article/download/1193/1982/8214

The effect of daily peanut consumption on indicators of ... A diet that includes nuts is associated with a reduced risk of cardiovascular disease and cardiovascular disease risk factors [1–4]. Peanuts and ...

4. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2022.853378/full

Effect of Peanut Consumption on Cardiovascular Risk ... The evidence for our major finding, that peanut product consumption improves the lipid profile, was rated as moderately strong in the case of ...

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2173094

Nut/Peanut Consumption and Mortality This cohort study demonstrates that nut consumption is associated with decreased overall and cardiovascular disease mortality across ...

6. healthline.com healthline.com/nutrition/peanuts

Peanuts 101: Nutrition Facts and Health Benefits Peanuts are rich in protein, fat, and various healthy nutrients. Studies show that peanuts may even be useful for weight loss and are linked to a reduced risk ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213453019301004

Health aspects of peanuts as an outcome of its chemical ... Specifically, nut consumption has been reported to be significantly associated with reduced risk of cancer, cardiovascular, respiratory, infectious, renal and ...

8. webmd.com webmd.com/diet/health-benefits-peanuts

Nutrition Facts and Health Benefits of Peanuts Peanuts are a rich source of nutrients. They contain fiber, B vitamins, vitamin E, and minerals such as iron, zinc, potassium, and magnesium.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5056823/

Impact of peanut consumption in The LEAP Study Participants randomized to peanut consumption (except those who were diagnosed with peanut allergy) were advised to eat at least 6g peanut protein/week ...