Peanuts and Glycemic Control

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654651
• Other study ID #: use PKE_PEANUT
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Type2 Diabetes

Intervention

Drug:
• Peanut
Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.
• High carbohydrate snack
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).

Locations

Country	Name	City	State
United States	Pennsylvania State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	The Peanut Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Plasma Glucose	Within-condition mean differences (change from baseline).	6 weeks
Secondary	Fructosamine	Within-condition mean differences (change from baseline).	6 weeks
Secondary	Fasting Insulin	Within-condition mean differences (change from baseline).	6 weeks
Secondary	Peripheral Systolic and Diastolic Blood Pressure	Within-condition mean differences (change from baseline).	6 weeks
Secondary	Central Systolic and Diastolic Blood Pressure	Within-condition mean differences (change from baseline).	6 weeks
Secondary	Carotid Femoral Pulse Wave Velocity	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 weeks
Secondary	Augmentation Index (%)	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).	6 weeks
Secondary	LDL Cholesterol	Within-condition mean differences (change from baseline).	6 weeks
Secondary	HDL Cholesterol	Within-condition mean differences (change from baseline).	6 weeks
Secondary	Total Cholesterol	Within-condition mean differences (change from baseline).	6 weeks
Secondary	Triglycerides	Within-condition mean differences (change from baseline).	6 weeks
Secondary	Body Weight	Within-condition mean differences (change from baseline).	6 weeks
Secondary	Microbiota Alpha-diversity	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	6 weeks