Clinical trial NCT03654651: Peanuts and Glycemic Control
Official title: The Role of the Microbiome in Blood Glucose Regulation in Response to Peanut Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type2 Diabetes
Cardiovascular Diseases
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: The Peanut Institute
First posted: 2018-08-31
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fasting Plasma Glucose
timeFrame: 6 weeks
Secondary outcomes:
measure: Fructosamine
timeFrame: 6 weeks
measure: Fasting Insulin
timeFrame: 6 weeks
measure: Peripheral Systolic and Diastolic Blood Pressure
timeFrame: 6 weeks
measure: Central Systolic and Diastolic Blood Pressure
timeFrame: 6 weeks
measure: Carotid Femoral Pulse Wave Velocity
timeFrame: 6 weeks
measure: Augmentation Index (%)
timeFrame: 6 weeks
measure: LDL Cholesterol
timeFrame: 6 weeks
measure: HDL Cholesterol
timeFrame: 6 weeks
measure: Total Cholesterol
timeFrame: 6 weeks
measure: Triglycerides
timeFrame: 6 weeks
measure: Body Weight
timeFrame: 6 weeks
measure: Microbiota Alpha-diversity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Penny M Kris-Etherton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Kristina S Petersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sapp PA, Kris-Etherton PM, Petersen KS. Peanuts or an Isocaloric Lower Fat, Higher Carbohydrate Nighttime Snack Have Similar Effects on Fasting Glucose in Adults with Elevated Fasting Glucose Concentrations: a 6-Week Randomized Crossover Trial. J Nutr. 2022 Jan 11;152(1):153-162. doi: 10.1093/jn/nxab347.