Peanuts for Cardiometabolic, Brain, and Intestinal Health

Last updated: March 7, 2025
Sponsor: Georgia State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Hormone Deficiencies

Diabetes (Pediatric)

Treatment

Peanuts

Clinical Study ID

NCT06867198
H25014
  • Ages 20-59
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • men and women

  • 20-59 years of age

  • Prediabetes (fasting blood glucose levels 100-125 mg/dL and/or HbA1c between 5.7-6.4%)

Exclusion

Exclusion Criteria:

  • Allergies to peanuts and peanut products

  • Use of insulin, antidiabetic, antibiotics, and anti-inflammatory drugs

  • Active cancer, gastrointestinal, renal, cardiovascular, thyroid, and neurologicaldiseases or severe head injury

  • Smoking

  • Consumes greater than 2 alcoholic beverages per day

  • Consumes antioxidant, probiotic, and prebiotic supplements

  • Pregnant or Lactating

  • Actively participating in a weight loss program

Study Design

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: Peanuts
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
September 30, 2027

Study Description

In the US, 37.1 million adults have diabetes mellitus and 96 million have prediabetes. Type 2 diabetes mellitus (T2DM) accounts for 95% of the cases and results in many public health complications that increase economic burden and reduce productivity and quality of life. Eight out of 10 people with T2DM die from cardiovascular disease, while those with T2DM also face a 50% higher risk of developing dementia compared to healthy individuals. Also, studies indicate that intestinal health significantly influences the development of T2DM. Of note, the burden of T2DM is particularly pronounced in non-Hispanic Black and Hispanic populations compared to the non-Hispanic White population. Prevention and treatment of T2DM focus on lifestyle changes including dietary modifications. Plant-based foods, including peanuts and peanut products, have been increasingly recognized for their importance in the prevention and management of prediabetes and T2DM due to their unique nutritional profile, including their favorable fatty acid composition, fiber content, and bioactive compounds. While emerging evidence indicates that peanut improves cardiometabolic, cognitive and intestinal health, no studies have collectively and comprehensively evaluated the effects of peanut or peanut product consumption on the cardiometabolic, cognitive, and intestinal health of individuals with prediabetes or T2DM. Thus, this study aims to investigate whether adults with prediabetes consuming 43 g of peanut butter (1 snack 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 six months will have 1) reduced levels of serum HbA1c, fasting glucose (FBG), insulin, HOMA-IR (homeostatic model assessment of insulin resistance) and improved lipid profile, 2) reduced blood pressure, improved endothelial function, arterial stiffness and microvascular function, 3) Improved gut microbiota composition and reduced intestinal permeability, 4) improved cognitive function (verbal memory and executive functions [inhibition, working memory, cognitive flexibility]) and brain health metrics as assessed by neuroimaging, and 5) reduced serum markers of oxidative stress and inflammation. The effectiveness of the intervention on the abovementioned outcomes among races including non-Hispanic Black (NHBA), non-Hispanic White (NHWA), non-Hispanic Asian (NHAA) and Hispanic (HA) adults will also be compared. Lastly, whether changes in cardiometabolic and cognitive outcomes are associated with changes in intestinal microbiota outcomes and whether changes in cardiometabolic outcomes are associated with changes in cognitive function parameters will be explored.

Connect with a study center

  • Georgia State University

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

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