Cardiovascular Diseases, Type2 Diabetes
Conditions
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.
Interventions
DRUGPeanut
Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.
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).
Sponsors
The Peanut Institute
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Plasma Glucose | 6 weeks | Within-condition mean differences (change from baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Insulin | 6 weeks | Within-condition mean differences (change from baseline). |
| Peripheral Systolic and Diastolic Blood Pressure | 6 weeks | Within-condition mean differences (change from baseline). |
| Central Systolic and Diastolic Blood Pressure | 6 weeks | Within-condition mean differences (change from baseline). |
| Carotid Femoral Pulse Wave Velocity | 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). |
| Augmentation Index (%) | 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). |
| Fructosamine | 6 weeks | Within-condition mean differences (change from baseline). |
| HDL Cholesterol | 6 weeks | Within-condition mean differences (change from baseline). |
| Total Cholesterol | 6 weeks | Within-condition mean differences (change from baseline). |
| Triglycerides | 6 weeks | Within-condition mean differences (change from baseline). |
| Body Weight | 6 weeks | Within-condition mean differences (change from baseline). |
| Microbiota Alpha-diversity | 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 |
| LDL Cholesterol | 6 weeks | Within-condition mean differences (change from baseline). |
Countries
United States
Participant flow
Recruitment details
267 participants were screened for eligibility
Pre-assignment details
51 participants were randomized. One participant withdrew from study before receiving either intervention
Participants by arm
| Arm | Count |
|---|---|
| Evening Peanut Consumption-Evening Snack Sequence First intervention:
Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).
Peanut: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.
Second Intervention:
Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).
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). | 25 |
| Evening Snack-Evening Peanut Consumption Sequence First Intervention:
Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).
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).
Second Intervention:
Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).
Peanut: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (6 Weeks) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Evening Snack-Evening Peanut Consumption Sequence | Total | Evening Peanut Consumption-Evening Snack Sequence |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 48 Participants | 24 Participants |
| Age, Continuous | 43 years STANDARD_DEVIATION 15 | 42 years STANDARD_DEVIATION 15 | 40 years STANDARD_DEVIATION 15 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 11 Participants | 24 Participants | 13 Participants |
| Sex: Female, Male Male | 14 Participants | 26 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Fasting Plasma Glucose
Within-condition mean differences (change from baseline).
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Evening Peanut Consumption | Fasting Plasma Glucose | -0.9 mg/dL |
| Evening Lower-fat Higher-carbohydrate Snack | Fasting Plasma Glucose | -0.4 mg/dL |
95% CI: [-2.7, 1.6]Mixed Models Analysis
95% CI: [-2.7, 0.9]Mixed Models Analysis
95% CI: [-2.2, 1.4]Mixed Models Analysis
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).
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Evening Peanut Consumption | Augmentation Index (%) | -0.4 % adjusted to a HR of 75 BPM |
| Evening Lower-fat Higher-carbohydrate Snack | Augmentation Index (%) | 0.2 % adjusted to a HR of 75 BPM |
95% CI: [-5.9, 3.3]Mixed Models Analysis
95% CI: [-3.7, 2.9]Mixed Models Analysis
95% CI: [-4, 4.3]Mixed Models Analysis
Secondary
Body Weight
Within-condition mean differences (change from baseline).
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Evening Peanut Consumption | Body Weight | 0.2 kg |
| Evening Lower-fat Higher-carbohydrate Snack | Body Weight | 0.0 kg |
95% CI: [-0.3, 0.7]Mixed Models Analysis
95% CI: [-0.1, 1.5]Mixed Models Analysis
95% CI: [-0.5, 0.5]Mixed Models Analysis
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).
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Evening Peanut Consumption | Carotid Femoral Pulse Wave Velocity | 0.3 m/s |
| Evening Lower-fat Higher-carbohydrate Snack | Carotid Femoral Pulse Wave Velocity | 0.1 m/s |
95% CI: [-0.1, 0.5]Mixed Models Analysis
95% CI: [0.1, 0.6]Mixed Models Analysis
95% CI: [-0.1, 0.3]Mixed Models Analysis
Secondary
Central Systolic and Diastolic Blood Pressure
Within-condition mean differences (change from baseline).
Time frame: 6 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Evening Peanut Consumption | Central Systolic and Diastolic Blood Pressure | Central systolic within-condition mean difference | 0.6 mmHg |
| Evening Peanut Consumption | Central Systolic and Diastolic Blood Pressure | Central diastolic within-condition mean difference | 0.5 mmHg |
| Evening Lower-fat Higher-carbohydrate Snack | Central Systolic and Diastolic Blood Pressure | Central systolic within-condition mean difference | -0.4 mmHg |
| Evening Lower-fat Higher-carbohydrate Snack | Central Systolic and Diastolic Blood Pressure | Central diastolic within-condition mean difference | -0.4 mmHg |
Comparison: central systolic BP95% CI: [-2.4, 4.4]Mixed Models Analysis
Comparison: central diastolic BP95% CI: [-1.7, 3.3]Mixed Models Analysis
Comparison: central systolic BP change from baseline95% CI: [-1.9, 3.1]Mixed Models Analysis
Comparison: central systolic BP change from baseline95% CI: [-2.9, 2.1]Mixed Models Analysis
Comparison: central diastolic BP change from baseline95% CI: [-1.5, 2.6]Mixed Models Analysis
Comparison: central diastolic BP change from baseline95% CI: [-2.4, 1.6]Mixed Models Analysis
Secondary
Fasting Insulin
Within-condition mean differences (change from baseline).
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Evening Peanut Consumption | Fasting Insulin | -0.2 umol/L |
| Evening Lower-fat Higher-carbohydrate Snack | Fasting Insulin | -0.8 umol/L |
95% CI: [-1.2, 2.1]Mixed Models Analysis
95% CI: [-1.5, 1]Mixed Models Analysis
95% CI: [-2.1, 0.5]Mixed Models Analysis
Secondary
Fructosamine
Within-condition mean differences (change from baseline).
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Evening Peanut Consumption | Fructosamine | -4.0 umol/L |
| Evening Lower-fat Higher-carbohydrate Snack | Fructosamine | -3.8 umol/L |
95% CI: [-4.8, 3.4]Mixed Models Analysis
95% CI: [-5.1, 5.4]Mixed Models Analysis
95% CI: [-5.1, 5.4]Mixed Models Analysis
Secondary
HDL Cholesterol
Within-condition mean differences (change from baseline).
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Evening Peanut Consumption | HDL Cholesterol | 0.6 mg/dL |
| Evening Lower-fat Higher-carbohydrate Snack | HDL Cholesterol | 0.6 mg/dL |
95% CI: [-2.3, 2.3]Mixed Models Analysis
95% CI: [-0.6, 1.8]Mixed Models Analysis
95% CI: [-1.6, 2.3]Mixed Models Analysis
Secondary
LDL Cholesterol
Within-condition mean differences (change from baseline).
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Evening Peanut Consumption | LDL Cholesterol | 2.4 mg/dL |
| Evening Lower-fat Higher-carbohydrate Snack | LDL Cholesterol | -2.3 mg/dL |
95% CI: [-1.4, 9.8]Mixed Models Analysis
95% CI: [-2.1, 6.9]Mixed Models Analysis
95% CI: [-6.8, 2.2]Mixed Models Analysis
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
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Evening Peanut Consumption | Microbiota Alpha-diversity | 10.4 Faith's Phylogenetic Diversity Score |
| Evening Lower-fat Higher-carbohydrate Snack | Microbiota Alpha-diversity | 10.6 Faith's Phylogenetic Diversity Score |
Secondary
Peripheral Systolic and Diastolic Blood Pressure
Within-condition mean differences (change from baseline).
Time frame: 6 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Evening Peanut Consumption | Peripheral Systolic and Diastolic Blood Pressure | Peripheral systolic within-condition mean difference | 0.4 mmHg |
| Evening Peanut Consumption | Peripheral Systolic and Diastolic Blood Pressure | Peripheral diastolic within-condition mean difference | 0.5 mmHg |
| Evening Lower-fat Higher-carbohydrate Snack | Peripheral Systolic and Diastolic Blood Pressure | Peripheral systolic within-condition mean difference | -0.3 mmHg |
| Evening Lower-fat Higher-carbohydrate Snack | Peripheral Systolic and Diastolic Blood Pressure | Peripheral diastolic within-condition mean difference | -0.0 mmHg |
Comparison: peripheral systolic BP95% CI: [-3.1, 4.6]Mixed Models Analysis
Comparison: peripheral diastolic BP95% CI: [-2.1, 2.9]Mixed Models Analysis
Comparison: peripheral systolic BP change from baseline95% CI: [-2.5, 3.3]Mixed Models Analysis
Comparison: peripheral systolic BP change from baseline95% CI: [-3.1, 2.6]Mixed Models Analysis
Comparison: peripheral diastolic BP change from baseline95% CI: [-1.5, 2.5]Mixed Models Analysis
Comparison: peripheral diastolic BP change from baseline95% CI: [-2, 2]Mixed Models Analysis
Secondary
Total Cholesterol
Within-condition mean differences (change from baseline).
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Evening Peanut Consumption | Total Cholesterol | 0.1 mg/dL |
| Evening Lower-fat Higher-carbohydrate Snack | Total Cholesterol | -2.7 mg/dL |
95% CI: [-3.8, 8.2]Mixed Models Analysis
95% CI: [-4.9, 5.1]Mixed Models Analysis
95% CI: [-7.8, 2.3]Mixed Models Analysis
Secondary
Triglycerides
Within-condition mean differences (change from baseline).
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Evening Peanut Consumption | Triglycerides | -17 mg/dL |
| Evening Lower-fat Higher-carbohydrate Snack | Triglycerides | -5.7 mg/dL |
95% CI: [-18.3, 2.8]Mixed Models Analysis
95% CI: [-29.1, -4.8]Mixed Models Analysis
95% CI: [-17.1, 5.7]Mixed Models Analysis