Phase 2
N=51
Peanuts and Glycemic Control
Type2 Diabetes · Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03654651 ↗Enrolled (actual)
51
Serious AEs
—
Results posted
May 2022
Primary outcome: Primary: Fasting Plasma Glucose — -0.9; -0.4 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Peanut (Drug); High carbohydrate snack (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Penn State University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fasting Plasma Glucose |
-0.9; -0.4 | — |
| SECONDARY Fructosamine |
-4.0; -3.8 | — |
| SECONDARY Fasting Insulin |
-0.2; -0.8 | — |
| SECONDARY Peripheral Systolic and Diastolic Blood Pressure |
0.4; -0.3; 0.5; -0.0 | — |
| SECONDARY Central Systolic and Diastolic Blood Pressure |
0.6; -0.4; 0.5; -0.4 | — |
| SECONDARY Carotid Femoral Pulse Wave Velocity |
0.3; 0.1 | — |
| SECONDARY Augmentation Index (%) |
-0.4; 0.2 | — |
| SECONDARY LDL Cholesterol |
2.4; -2.3 | — |
| SECONDARY HDL Cholesterol |
0.6; 0.6 | — |
| SECONDARY Total Cholesterol |
0.1; -2.7 | — |
| SECONDARY Triglycerides |
-17; -5.7 | — |
| SECONDARY Body Weight |
0.2; 0.0 | — |
| SECONDARY Microbiota Alpha-diversity |
10.4; 10.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03654651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.