Peanuts for Prediabetes

Recruiting in Palo Alto (17 mi)

Overseen by Rafaela G Feresin, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Georgia State University

Must not be taking: Insulin, Antidiabetics, Antibiotics, Anti-inflammatories

Disqualifiers: Cancer, Renal, Cardiovascular, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The overall objective of this 13-month randomized crossover study is to seek evidence demonstrating that daily consumption of peanuts and peanut products improve cardiometabolic, cognitive, and intestinal health in a racially diverse prediabetes population.

Will I have to stop taking my current medications?

The trial requires that you stop taking insulin, antidiabetic, antibiotics, and anti-inflammatory drugs to participate.

What data supports the effectiveness of the treatment Peanuts for prediabetes?

Research shows that consuming peanuts as part of a weight loss diet can help improve markers of blood sugar control in adults at risk of type 2 diabetes. Additionally, nuts like almonds and pistachios have been shown to improve cardiovascular risk factors and blood sugar levels in prediabetic individuals, suggesting that peanuts might have similar benefits. ^{1 2 3 4 5}

Is it safe for humans to consume peanuts?

Peanuts are generally safe for most people, but they can cause severe allergic reactions in some individuals. Studies have shown that early introduction of peanuts in infants at high risk of allergy can reduce the risk of developing a peanut allergy. In adults, consuming peanuts as part of a diet did not show negative effects on blood sugar or weight, suggesting they are safe for general consumption. ^{3 5 6 7 8}

How do peanuts as a treatment for prediabetes differ from other treatments?

Peanuts as a treatment for prediabetes are unique because they are a natural food source that can be easily incorporated into meals, potentially improving blood sugar control and reducing appetite. Unlike traditional low-fat diets, consuming peanuts before meals may enhance satiety and help moderate glucose levels, offering a simple dietary approach to managing prediabetes. ^{2 8 9 10 11}

Research Team

Rafaela G Feresin, PhD

Principal Investigator

Georgia State University

Eligibility Criteria

This trial is for adults with conditions like high blood pressure, prediabetes, and insulin resistance. It's especially focused on those who might have early heart problems or issues with blood sugar control. People with polycystic ovary syndrome are also included to see how peanuts affect them.

Inclusion Criteria

I am either a man or a woman.

I am between 20 and 59 years old.

I have been diagnosed with prediabetes based on my blood sugar levels.

Exclusion Criteria

Consumption of greater than 2 alcoholic beverages per day

Allergies to peanuts and peanut products

Smoking

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume peanuts and peanut products to assess their impact on cardiometabolic, cognitive, and intestinal health

6 months

Regular visits at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Peanuts (Cancer Vaccine)

Trial Overview The study tests if eating peanuts daily for 13 months can improve heart health, brain function, and gut health in a diverse group of people at risk of diabetes. Participants will switch between having peanuts and not having them over the course of the study.

Participant Groups

Group I: Peanut Experimental Treatment 1 Intervention

43 g of peanut butter (1snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for 6 months

Group II: Control Active Control 1 Intervention

No intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Georgia State University Atlanta, GA

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Patients Recruited

33,600+

The Peanut Institute

Collaborator

Trials

7

Patients Recruited

350+

USDA ARS

Collaborator

Trials

3

Patients Recruited

200+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of pistachio consumption on plasma lipoprotein subclasses in pre-diabetic subjects. Hernández-Alonso, P., Salas-Salvadó, J., Baldrich-Mora, M., et al.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of a Peanut-Enriched Weight Loss Diet Compared to a Low-Fat Weight Loss Diet on Body Weight, Blood Pressure, and Glycemic Control: A Randomized Controlled Trial. Petersen, KS., Murphy, J., Whitbread, J., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Almond consumption and cardiovascular risk factors in adults with prediabetes. Wien, M., Bleich, D., Raghuwanshi, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Prediabetes Outcome at National Guard Primary Health Care Centers in Riyadh, Saudi Arabia: Retrospective Chart Review. Alateeq, MA., Aljohani, M., Kinani, SS., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of peanut and grain bar preloads on postmeal satiety, glycemia, and weight loss in healthy individuals: an acute and a chronic randomized intervention trial. Johnston, CS., Trier, CM., Fleming, KR.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pros and cons of pre-emptive screening programmes before peanut introduction in infancy. Abrams, EM., Brough, HA., Keet, C., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The National Institutes of Allergy and Infectious Diseases sponsored guidelines on preventing peanut allergy: A new paradigm in food allergy prevention. Greenhawt, M.[2017]

In a study involving 32 patients with type 2 diabetes mellitus, both peanuts and almonds incorporated into a low carbohydrate diet significantly reduced fasting and postprandial blood glucose levels after three months, showing similar efficacy in managing blood sugar.

While both nuts did not affect body mass index or blood lipid profiles, almonds showed a significant decrease in glycated hemoglobin A1c (HbA1c) levels, suggesting potential benefits that require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial to Compare the Effect of Peanuts and Almonds on the Cardio-Metabolic and Inflammatory Parameters in Patients with Type 2 Diabetes Mellitus. Hou, YY., Ojo, O., Wang, LL., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and second-meal effects of peanuts on glycaemic response and appetite in obese women with high type 2 diabetes risk: a randomised cross-over clinical trial. Reis, CE., Ribeiro, DN., Costa, NM., et al.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge, Attitudes and Practice Among Primary Care Physicians in Sudan Regarding Prediabetes: A Cross-Sectional Survey. Saleh, AM., Almobarak, AO., Badi, S., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inclusion of walnut in the diets of adults at risk for type 2 diabetes and their dietary pattern changes: a randomized, controlled, cross-over trial. Njike, VY., Yarandi, N., Petraro, P., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of pistachio consumption on plasma lipoprotein subclasses in pre-diabetic subjects. [2015]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of a Peanut-Enriched Weight Loss Diet Compared to a Low-Fat Weight Loss Diet on Body Weight, Blood Pressure, and Glycemic Control: A Randomized Controlled Trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Almond consumption and cardiovascular risk factors in adults with prediabetes. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Prediabetes Outcome at National Guard Primary Health Care Centers in Riyadh, Saudi Arabia: Retrospective Chart Review. [2020]

5. England pubmed.ncbi.nlm.nih.gov

The effect of peanut and grain bar preloads on postmeal satiety, glycemia, and weight loss in healthy individuals: an acute and a chronic randomized intervention trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Pros and cons of pre-emptive screening programmes before peanut introduction in infancy. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

The National Institutes of Allergy and Infectious Diseases sponsored guidelines on preventing peanut allergy: A new paradigm in food allergy prevention. [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial to Compare the Effect of Peanuts and Almonds on the Cardio-Metabolic and Inflammatory Parameters in Patients with Type 2 Diabetes Mellitus. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Acute and second-meal effects of peanuts on glycaemic response and appetite in obese women with high type 2 diabetes risk: a randomised cross-over clinical trial. [2015]

10. Iran pubmed.ncbi.nlm.nih.gov

Knowledge, Attitudes and Practice Among Primary Care Physicians in Sudan Regarding Prediabetes: A Cross-Sectional Survey. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Inclusion of walnut in the diets of adults at risk for type 2 diabetes and their dietary pattern changes: a randomized, controlled, cross-over trial. [2019]