Type2 DiabetesPhase 2NCT03654651

Peanuts and Glycemic Control

A Phase 2 study testing Peanut and High carbohydrate snack in people with Type2 Diabetes and Cardiovascular Diseases, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Type2 Diabetes, Cardiovascular Diseases
What is being tested?: Peanut and High carbohydrate snack
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2018to 20 Dec 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Non-smoking
Impaired fasting glucose at screening (≥ 100 mg/dL).
BMI ≥20 and ≤40 kg/m2.

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Pennsylvania State University
University Park, Pennsylvania, 16802

Other trials in United States

About this study

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

Read the 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.

Conditions: Type2 Diabetes, Cardiovascular Diseases
Being tested: Peanut, High carbohydrate snack
Medical subject headings: Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PeanutDrug
Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.
High carbohydrate snackDrug
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).

Study groups in NCT03654651
Study group	Role	What they receive
Evening Peanut Consumption	Experimental	Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep). Receives: Drug: Peanut
Evening Snack	Active comparator	Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep). Receives: Drug: High carbohydrate snack

What is being measured

The primary outcome is the main question the study is designed to answer.

Fasting Plasma Glucose
Within-condition mean differences (change from baseline).
Measured: 6 weeks

Secondary outcomes (12)

Fructosamine
Within-condition mean differences (change from baseline).
Measured: 6 weeks
Fasting Insulin
Within-condition mean differences (change from baseline).
Measured: 6 weeks
Peripheral Systolic and Diastolic Blood Pressure
Within-condition mean differences (change from baseline).
Measured: 6 weeks
Central Systolic and Diastolic Blood Pressure
Within-condition mean differences (change from baseline).
Measured: 6 weeks
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).
Measured: 6 weeks
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).
Measured: 6 weeks
LDL Cholesterol
Within-condition mean differences (change from baseline).
Measured: 6 weeks
HDL Cholesterol
Within-condition mean differences (change from baseline).
Measured: 6 weeks
Total Cholesterol
Within-condition mean differences (change from baseline).
Measured: 6 weeks
Triglycerides
Within-condition mean differences (change from baseline).
Measured: 6 weeks
Body Weight
Within-condition mean differences (change from baseline).
Measured: 6 weeks
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
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201820 Dec 2019

First posted31 Aug 2018
Study start1 Oct 2018
Primary completion20 Dec 2019
Study completion20 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03654651
Sponsor's protocol ID: use PKE_PEANUT
Status last verified: Aug 2023
First submitted: 29 Aug 2018
Last updated: 18 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34562081

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of the Microbiome in Blood Glucose Regulation in Response to Peanut Consumption
ClinicalTrials.gov ID: NCT03654651
Acronym / sponsor ID: use PKE_PEANUT
Conditions: Type2 Diabetes, Cardiovascular Diseases
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Penn State UniversityUniversity, hospital or other
Collaborators: The Peanut Institute
Study start: 1 Oct 2018 (actual)
Primary completion: 20 Dec 2019 (actual)
Study completion: 20 Dec 2019 (actual)
First posted: 31 Aug 2018 (actual)
Results: Posted 13 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Evening Peanut Consumption	Experimental	Drug: PeanutParticipants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).
Evening Snack	Active comparator	Drug: High carbohydrate snackParticipants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Non-smoking
Impaired fasting glucose at screening (≥ 100 mg/dL).
BMI ≥20 and ≤40 kg/m2.

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PeanutRoasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.	Drug	Evening Peanut Consumption
High carbohydrate snackWhole 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).	Drug	Evening Snack

Primary outcome

Fasting Plasma Glucose
Time frame: 6 weeks
Within-condition mean differences (change from baseline).

12 secondary outcomes

Fructosamine
Time frame: 6 weeks
Fasting Insulin
Time frame: 6 weeks
Peripheral Systolic and Diastolic Blood Pressure
Time frame: 6 weeks
Central Systolic and Diastolic Blood Pressure
Time frame: 6 weeks
Carotid Femoral Pulse Wave Velocity
Time frame: 6 weeks
Augmentation Index (%)
Time frame: 6 weeks
LDL Cholesterol
Time frame: 6 weeks
HDL Cholesterol
Time frame: 6 weeks
Total Cholesterol
Time frame: 6 weeks
Triglycerides
Time frame: 6 weeks
Body Weight
Time frame: 6 weeks
Microbiota Alpha-diversity
Time frame: 6 weeks

Results and safety

Results posted to the registry on 13 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Evening Peanut Consumption - Evening Snack Sequence	26	25
Evening Snack-Evening Peanut Consumption Sequence	25	25

Primary outcome: Fasting Plasma Glucose

Time frame: 6 weeks. Least squares mean (95% Confidence Interval). Unit: mg/dL

Measure	Evening Peanut Consumption n = 50	Evening Lower-fat Higher-carbohydrate Snack n = 50
Value	-0.9 (-2.7 to 0.9)	-0.4 (-2.2 to 1.4)

Evening Peanut Consumption vs Evening Lower-fat Higher-carbohydrate Snack: Mean Difference (Final Values): -0.6 (95% CI -2.7 to 1.6), Mixed Models Analysis
Evening Peanut Consumption: Mean Difference (Final Values): -0.9 (95% CI -2.7 to 0.9), Mixed Models Analysis
Evening Lower-fat Higher-carbohydrate Snack: Mean Difference (Final Values): -0.4 (95% CI -2.2 to 1.4), Mixed Models Analysis

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: All 16-wks of trial. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Evening Peanut Consumption	0 of 0	0 of 50 (0%)	0
Evening Lower-Fat Higher-Carbohydrate Snack	0 of 0	0 of 50 (0%)	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34562081Sapp 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.
Individual participant dataSharing planned: No

Related trials for Type2 Diabetes

Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Recruiting
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Type 2 Diabetes, Healhty
RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Penny M Kris-Etherton, PhD principal investigator

Penn State University

Kristina S Petersen, PhD principal investigator

Penn State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Peanut and High carbohydrate snack in people with Type2 Diabetes and Cardiovascular Diseases, run by Penn State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting Plasma Glucose (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03654651, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.