Trial Outcomes & Findings for Peanuts and Glycemic Control (NCT NCT03654651)
NCT ID: NCT03654651
Last Updated: 2023-08-18
Results Overview
Within-condition mean differences (change from baseline).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
6 weeks
Results posted on
2023-08-18
Participant Flow
267 participants were screened for eligibility
51 participants were randomized. One participant withdrew from study before receiving either intervention
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
First Intervention (6 Weeks)
STARTED
|
26
|
25
|
|
First Intervention (6 Weeks)
COMPLETED
|
25
|
25
|
|
First Intervention (6 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Washout Period (2-weeks)
STARTED
|
25
|
25
|
|
Washout Period (2-weeks)
COMPLETED
|
25
|
25
|
|
Washout Period (2-weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (6 Weeks)
STARTED
|
25
|
25
|
|
Second Intervention (6 Weeks)
COMPLETED
|
25
|
25
|
|
Second Intervention (6 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
|---|---|---|
|
First Intervention (6 Weeks)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Evening Peanut Consumption-Evening Snack Sequence
n=25 Participants
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).
|
Evening Snack-Evening Peanut Consumption Sequence
n=25 Participants
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=25 Participants
|
24 Participants
n=25 Participants
|
48 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
2 Participants
n=50 Participants
|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 15 • n=25 Participants
|
43 years
STANDARD_DEVIATION 15 • n=25 Participants
|
42 years
STANDARD_DEVIATION 15 • n=50 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=25 Participants
|
11 Participants
n=25 Participants
|
24 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=25 Participants
|
14 Participants
n=25 Participants
|
26 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
50 participants
n=50 Participants
|
PRIMARY outcome
Timeframe: 6 weeksWithin-condition mean differences (change from baseline).
Outcome measures
| Measure |
Evening Peanut Consumption
n=50 Participants
Evening Peanut Consumption
|
Evening Lower-fat Higher-carbohydrate Snack
n=50 Participants
Evening lower-fat higher-carbohydrate snack
|
|---|---|---|
|
Fasting Plasma Glucose
|
-0.9 mg/dL
Interval -2.7 to 0.9
|
-0.4 mg/dL
Interval -2.2 to 1.4
|
SECONDARY outcome
Timeframe: 6 weeksWithin-condition mean differences (change from baseline).
Outcome measures
| Measure |
Evening Peanut Consumption
n=50 Participants
Evening Peanut Consumption
|
Evening Lower-fat Higher-carbohydrate Snack
n=50 Participants
Evening lower-fat higher-carbohydrate snack
|
|---|---|---|
|
Fructosamine
|
-4.0 umol/L
Interval -5.1 to 5.4
|
-3.8 umol/L
Interval -5.1 to 5.4
|
SECONDARY outcome
Timeframe: 6 weeksWithin-condition mean differences (change from baseline).
Outcome measures
| Measure |
Evening Peanut Consumption
n=50 Participants
Evening Peanut Consumption
|
Evening Lower-fat Higher-carbohydrate Snack
n=50 Participants
Evening lower-fat higher-carbohydrate snack
|
|---|---|---|
|
Fasting Insulin
|
-0.2 umol/L
Interval -1.5 to 1.0
|
-0.8 umol/L
Interval -2.1 to 0.5
|
SECONDARY outcome
Timeframe: 6 weeksWithin-condition mean differences (change from baseline).
Outcome measures
| Measure |
Evening Peanut Consumption
n=50 Participants
Evening Peanut Consumption
|
Evening Lower-fat Higher-carbohydrate Snack
n=50 Participants
Evening lower-fat higher-carbohydrate snack
|
|---|---|---|
|
Peripheral Systolic and Diastolic Blood Pressure
Peripheral diastolic within-condition mean difference
|
0.5 mmHg
Interval -1.5 to 2.5
|
-0.0 mmHg
Interval -2.0 to 2.0
|
|
Peripheral Systolic and Diastolic Blood Pressure
Peripheral systolic within-condition mean difference
|
0.4 mmHg
Interval -2.5 to 3.3
|
-0.3 mmHg
Interval -3.1 to 2.6
|
SECONDARY outcome
Timeframe: 6 weeksWithin-condition mean differences (change from baseline).
Outcome measures
| Measure |
Evening Peanut Consumption
n=50 Participants
Evening Peanut Consumption
|
Evening Lower-fat Higher-carbohydrate Snack
n=50 Participants
Evening lower-fat higher-carbohydrate snack
|
|---|---|---|
|
Central Systolic and Diastolic Blood Pressure
Central systolic within-condition mean difference
|
0.6 mmHg
Interval -1.9 to 3.1
|
-0.4 mmHg
Interval -2.9 to 2.1
|
|
Central Systolic and Diastolic Blood Pressure
Central diastolic within-condition mean difference
|
0.5 mmHg
Interval -1.5 to 2.6
|
-0.4 mmHg
Interval -2.4 to 1.6
|
SECONDARY outcome
Timeframe: 6 weeksCarotid-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).
Outcome measures
| Measure |
Evening Peanut Consumption
n=50 Participants
Evening Peanut Consumption
|
Evening Lower-fat Higher-carbohydrate Snack
n=50 Participants
Evening lower-fat higher-carbohydrate snack
|
|---|---|---|
|
Carotid Femoral Pulse Wave Velocity
|
0.3 m/s
Interval 0.1 to 0.6
|
0.1 m/s
Interval -0.1 to 0.3
|
SECONDARY outcome
Timeframe: 6 weeksA 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).
Outcome measures
| Measure |
Evening Peanut Consumption
n=50 Participants
Evening Peanut Consumption
|
Evening Lower-fat Higher-carbohydrate Snack
n=50 Participants
Evening lower-fat higher-carbohydrate snack
|
|---|---|---|
|
Augmentation Index (%)
|
-0.4 % adjusted to a HR of 75 BPM
Interval -3.7 to 2.9
|
0.2 % adjusted to a HR of 75 BPM
Interval -4.0 to 4.3
|
SECONDARY outcome
Timeframe: 6 weeksWithin-condition mean differences (change from baseline).
Outcome measures
| Measure |
Evening Peanut Consumption
n=50 Participants
Evening Peanut Consumption
|
Evening Lower-fat Higher-carbohydrate Snack
n=50 Participants
Evening lower-fat higher-carbohydrate snack
|
|---|---|---|
|
LDL Cholesterol
|
2.4 mg/dL
Interval -2.1 to 6.9
|
-2.3 mg/dL
Interval -6.8 to 2.2
|
SECONDARY outcome
Timeframe: 6 weeksWithin-condition mean differences (change from baseline).
Outcome measures
| Measure |
Evening Peanut Consumption
n=50 Participants
Evening Peanut Consumption
|
Evening Lower-fat Higher-carbohydrate Snack
n=50 Participants
Evening lower-fat higher-carbohydrate snack
|
|---|---|---|
|
HDL Cholesterol
|
0.6 mg/dL
Interval -0.6 to 1.8
|
0.6 mg/dL
Interval -1.6 to 2.3
|
SECONDARY outcome
Timeframe: 6 weeksWithin-condition mean differences (change from baseline).
Outcome measures
| Measure |
Evening Peanut Consumption
n=50 Participants
Evening Peanut Consumption
|
Evening Lower-fat Higher-carbohydrate Snack
n=50 Participants
Evening lower-fat higher-carbohydrate snack
|
|---|---|---|
|
Total Cholesterol
|
0.1 mg/dL
Interval -4.9 to 5.1
|
-2.7 mg/dL
Interval -7.8 to 2.3
|
SECONDARY outcome
Timeframe: 6 weeksWithin-condition mean differences (change from baseline).
Outcome measures
| Measure |
Evening Peanut Consumption
n=50 Participants
Evening Peanut Consumption
|
Evening Lower-fat Higher-carbohydrate Snack
n=50 Participants
Evening lower-fat higher-carbohydrate snack
|
|---|---|---|
|
Triglycerides
|
-17 mg/dL
Interval -29.1 to -4.8
|
-5.7 mg/dL
Interval -17.1 to 5.7
|
SECONDARY outcome
Timeframe: 6 weeksWithin-condition mean differences (change from baseline).
Outcome measures
| Measure |
Evening Peanut Consumption
n=50 Participants
Evening Peanut Consumption
|
Evening Lower-fat Higher-carbohydrate Snack
n=50 Participants
Evening lower-fat higher-carbohydrate snack
|
|---|---|---|
|
Body Weight
|
0.2 kg
Interval -0.1 to 1.5
|
0.0 kg
Interval -0.5 to 0.5
|
SECONDARY outcome
Timeframe: 6 weeksMeasured 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
Outcome measures
| Measure |
Evening Peanut Consumption
n=50 Participants
Evening Peanut Consumption
|
Evening Lower-fat Higher-carbohydrate Snack
n=50 Participants
Evening lower-fat higher-carbohydrate snack
|
|---|---|---|
|
Microbiota Alpha-diversity
|
10.4 Faith's Phylogenetic Diversity Score
Interval 7.5 to 13.3
|
10.6 Faith's Phylogenetic Diversity Score
Interval 7.4 to 13.8
|
Adverse Events
Evening Peanut Consumption
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Evening Lower-Fat Higher-Carbohydrate Snack
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Penny Kris-Etherton
The Pennsylvania State University
Phone: 814-863-2923
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place