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Completed

NCT Number: NCT03654651

Peanuts and Glycemic Control

A two-period randomized crossover study will be conducted to determine the effect of peanuts on glycemic control, and elucidate the role of the microbiome in glucose regulation, in individuals with impaired fasting glucose.

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Key information

Conditions

Type2 Diabetes Cardiovascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

About this study

A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 6 weeks followed by a minimum 4-week wash-out period. During the peanut treatment, participants will consume one ounce per day (28 g) of peanuts as an evening snack. The control treatments will be an isocaloric higher carbohydrate snack consumed after the evening meal. Markers of glycemic control, cardiovascular risk factors and gut health will be assessed at the beginning and the end of each treatment period.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-smoking
  • Impaired fasting glucose at screening (≥ 100 mg/dL).
  • BMI ≥20 and ≤40 kg/m2.

Exclusion criteria

  • Diagnosed diabetes or fasting glucose >126 mg/dl
  • Systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
  • Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
  • Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
  • Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
  • Pregnancy or lactation
  • Weight loss of >=10% of body weight within the 6 months prior to enrolling in the study
  • Smoking or use of any tobacco products
  • Allergy to test foods
  • Consumption of >14 alcoholic drinks/week

Treatment and study plan

Peanut

Drug

Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.

High carbohydrate snack

Drug

Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine).

Primary outcomes

  1. Fasting Plasma Glucose

    Time frame: 6 weeks

    Within-condition mean differences (change from baseline).

Secondary outcomes

  1. Fructosamine

    Time frame: 6 weeks

    Within-condition mean differences (change from baseline).

  2. Fasting Insulin

    Time frame: 6 weeks

    Within-condition mean differences (change from baseline).

  3. Peripheral Systolic and Diastolic Blood Pressure

    Time frame: 6 weeks

    Within-condition mean differences (change from baseline).

  4. Central Systolic and Diastolic Blood Pressure

    Time frame: 6 weeks

    Within-condition mean differences (change from baseline).

  5. Carotid Femoral Pulse Wave Velocity

    Time frame: 6 weeks

    Carotid-femoral pulse wave velocity is a measure of arterial stiffness and is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery.

    Within-condition mean differences (change from baseline).

  6. Augmentation Index (%)

    Time frame: 6 weeks

    A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness

    Within-condition mean differences (change from baseline).

  7. LDL Cholesterol

    Time frame: 6 weeks

    Within-condition mean differences (change from baseline).

  8. HDL Cholesterol

    Time frame: 6 weeks

    Within-condition mean differences (change from baseline).

  9. Total Cholesterol

    Time frame: 6 weeks

    Within-condition mean differences (change from baseline).

  10. Triglycerides

    Time frame: 6 weeks

    Within-condition mean differences (change from baseline).

  11. Body Weight

    Time frame: 6 weeks

    Within-condition mean differences (change from baseline).

  12. Microbiota Alpha-diversity

    Time frame: 6 weeks

    Measured by Faith's Phylogenetic Diversity Score. This is a measure of biodiversity (based on phylogeny). Faith's phylogenetic diversity measures the amount of the phylogenetic tree covered by the bacterial community. It's a sum of the minimum branch lengths. A higher number (more branches), means more richness (more diversity). Increases in Faith's Phylogenetic Diversity is indicative of more richness and diversity but no standard reference range or clinically relevant values have been established.

    Presented as endpoint mean values with IQR

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • The Peanut Institute

Registry information

Official study title

The Role of the Microbiome in Blood Glucose Regulation in Response to Peanut Consumption

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2018
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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