Peanuts for Prediabetes

Overseen By Rafaela G Feresin, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Georgia State University

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

Disqualifiers: Cancer, Renal, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

72 Participants Needed

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

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

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

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

The Peanut Institute

Collaborator

Trials

7

Recruited

350+

USDA ARS

Collaborator

Trials

3

Recruited

200+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

Findings from Research

In a randomized cross-over trial involving 54 pre-diabetic subjects, chronic consumption of pistachios led to a significant decrease in small low-density lipoprotein particles (sLDL-P) and non-high-density lipoprotein particles (non-HDL-P), indicating a healthier lipoprotein profile.

The study found that pistachio consumption increased the percentage of small high-density lipoprotein particles (sHDL-P), suggesting that eating pistachios may help reduce cardiovascular disease risk, even when total plasma lipid levels remain unchanged.

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]

Consuming 35 g of peanuts before two main meals as part of a weight loss diet led to weight loss similar to a traditional low-fat diet over 6 months, with no significant difference in body weight between the two groups.

Participants who consumed peanuts experienced a greater reduction in systolic blood pressure compared to the control group, suggesting that peanut intake may help lower cardiovascular disease risk.

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]

In a study of 65 adults with prediabetes, a 16-week almond-enriched ADA diet led to significant improvements in insulin sensitivity, with reductions in insulin levels and insulin resistance compared to a nut-free diet.

The almond-enriched diet also resulted in clinically significant decreases in LDL cholesterol levels, indicating potential cardiovascular benefits for individuals with prediabetes.

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]

In a study of 92 prediabetic patients followed for three years, 76.08% remained in the prediabetic range, while only 16.4% reverted to normal blood sugar levels, indicating that many patients did not improve significantly despite interventions.

The use of metformin, a common medication for managing blood sugar, did not show a significant benefit in helping patients regress to a normal glycemic state, suggesting that more research is needed to explore effective interventions for prediabetes.

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]

In a study with 15 healthy adults, consuming a grain bar before a meal increased feelings of fullness more than eating peanuts or just drinking water, indicating that grain bars may enhance postmeal satiety.

In a longer trial with 44 overweight adults, those who consumed a grain bar before dinner lost more weight over eight weeks compared to those who had peanuts, suggesting that grain bars could be a helpful strategy for weight management.

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]

The Learning Early About Peanut study demonstrated that introducing peanuts early into the diets of high-risk infants (those with severe eczema or egg allergy) can reduce the risk of developing a peanut allergy by 81% by age 5.

The US National Institute of Allergy and Infectious Diseases recommends screening for peanut allergies in high-risk infants before introducing peanuts, contrasting with other international guidelines that do not support such screening, highlighting a debate on the best approach to prevent peanut allergies.

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]

Introducing peanuts to infants at high risk for allergies (like those with severe eczema or egg allergies) as early as 4-6 months can significantly reduce the risk of developing a peanut allergy, according to recent studies.

The updated guidelines recommend that parents and healthcare providers follow these early introduction practices to help lower the incidence of peanut allergies, emphasizing the importance of cooperation in implementing these recommendations.

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]

In a study involving 15 obese women at high risk for type 2 diabetes, adding peanut butter to breakfast significantly reduced post-meal glucose and NEFA levels compared to a control meal, indicating improved glucose metabolism.

Peanut butter consumption also increased gut satiety hormones (GLP-1, PYY, CCK) and decreased appetite ratings, suggesting that it may help manage hunger and food intake in individuals at risk for diabetes.

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]

A study involving 189 primary care physicians in Sudan found that 60.8% had satisfactory knowledge and positive attitudes towards prediabetes, indicating a good understanding of this critical health issue.

Physicians who attended relevant courses were twice as likely to have sufficient knowledge about prediabetes, highlighting the importance of continued education in improving healthcare practices and potentially reducing the risk of diabetes in the community.

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]

Including walnuts in the diets of 112 adults with prediabetes improved overall diet quality by increasing the intake of healthful foods like seafood and plant proteins, as well as beneficial fatty acids.

Participants who included walnuts in their diet also showed an increase in dairy consumption when calorie intake was regulated, suggesting that walnuts can help enhance the nutritional profile of diets for those at risk of diabetes.

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]