Cardiometabolic & Cognitive Effects of Peanut Butter in Prediabetes
2026年7月15日 更新者：Kristina Petersen PhD, APD, FAHA、Penn State University
Peanut Butter Glycemic Control, Cognition and Cardiovascular Health
The purpose of this study is to look at the effect of consuming peanut butter at breakfast on blood sugar control, cognitive function, and heart disease risk factors in middle-aged adults with prediabetes.
研究概览
详细说明
This is a 2-period, randomized, crossover study.
In random sequence order participants will undergo each of the following conditions for 12 weeks with a ≥ 8-week washout between the two periods: 1) provision of 43 g/day (1.5 oz/day) of peanut butter with instructions to consume it as part of breakfast (or the first meal of the day); 2) instructions to continue usual intake with matched study contact and resource provision.
Testing will be conducted at the beginning and end of each period.
研究类型
介入性
注册 (估计的)
56
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kristina Petersen, PhD
- 电话号码：+1 814 865 7206
- 邮箱：kup63@psu.edu
研究联系人备份
- 姓名：Stacey Meily
- 电话号码：+1 814 863 8622
- 邮箱：sas117@psu.edu
学习地点
-
-
Pennsylvania
-
University Park、Pennsylvania、美国、16802
- The Pennsylvania State University
-
接触：
- Kristina Petersen, PhD
- 电话号码：+1 814-865 7206
- 邮箱：kup63@psu.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age 40-65 years
- BMI 25 to 40 kg/m2
- HbA1c 5.7-6.4%
- Low habitual intake of peanut butter (<0.5 Tablespoons/day on average)
- Have a smartphone device or be willing to use one provided by the study
Exclusion Criteria:
- Hemoglobin <13.2 g/dL for men or < 11.7 g/dL for women at screening
- Fasting triglycerides >350 mg/dL at screening
- LDL-cholesterol ≥190 mg/dL assessed by the Martin-Hopkins equation at screening
- ≥10% change in body weight within the 6 months prior to enrollment
- Blood pressure >140/90 mmHg at screening
- Diagnosed type 1 or type 2 diabetes
- Takes any (prescription or over-the-counter) anti-hypertensive, lipid-lowering, glucose-lowering or body weight altering drugs
- Intake of supplements that affect the outcomes of interest (i.e., lipids, blood pressure, glucose, body weight, and microbiome) and are unwilling to cease during the study period.
- Unwilling to refrain from starting to take any supplements, vitamins, nutritional products, or health foods that are not prescribed by a doctor for the duration of the study
- Self-reported history of diagnosed liver, kidney, or autoimmune disease
- Self-reported history of a prior cardiovascular event (e.g., stroke, heart attack)
- Self-reported history of diagnosed neurological disease (e.g. Alzheimer's Disease, Parkinson's Disease, Multiple Sclerosis)
- Current pregnancy or intention of pregnancy within the next 12 months
- Lactation within the prior 6 months
- Peanut allergy/intolerance/sensitivity/dislike
- Antibiotic use within the prior four weeks
- Oral steroid use within the prior four weeks
- Use of tobacco or nicotine-containing products within the past 6 months
- History of cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer within the past 5 years (eligible if ≥5 years without recurrence)
- Participation in another clinical trial within 60 days of baseline
- Currently following a restricted or weight-loss diet
- Prior bariatric surgery
- Intake of >14 alcoholic drinks/week and/or not willing to avoid alcohol consumption for 48 hours prior to test visits
- Does not speak and/or understand English
- Unwilling to refrain from donating blood and/or plasma during the study
- Weight <110 lb
- Unwilling to contact study staff before enrolling in other health-related research and avoid participating in any research that may interfere with this study
- For individuals taking thyroid medication: abnormal thyroid stimulated hormone (TSH) concentration, or change in dose of thyroid medication within the last 6 months
- Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements, including being able to come to attend visits
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Peanut Butter-Usual Diet
In the first period, participants will be provided with 43 g/day of peanut butter with instructions to consume it at breakfast (or the first meal of the day).
In the second period, participants will be instructed to continue their usual intake.
|
Intake of 43 g/day of peanut butter as part of breakfast (or the first meal of the day)
Continue intake of usual diet.
|
|
有源比较器：Usual Diet-Peanut Butter
In the first period, participants will be instructed to continue their usual intake.
In the second period, participants will be provided with 43 g/day of peanut butter with instructions to consume it at breakfast (or the first meal of the day).
|
Intake of 43 g/day of peanut butter as part of breakfast (or the first meal of the day)
Continue intake of usual diet.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in HbA1c
大体时间：12 weeks
|
HbA1c will be assessed at the beginning and end of each 12-week period and expressed as percentage.
The change in HbA1c will be calculated as the post-condition value minus the pre-condition value and expressed as percentage point change.
|
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in fasting glucose
大体时间：12 weeks
|
Change in fasting plasma glucose expressed as mg/dL.
Change in glucose will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
|
12 weeks
|
|
Change in fasting insulin
大体时间：12 weeks
|
Change in fasting serum insulin expressed as micro IU/mL.
Change in insulin will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
|
12 weeks
|
|
Mean glucose
大体时间：12 weeks
|
Mean glucose assessed by a continuous glucose monitor (CGM) expressed as mg/dL.
The between-condition difference in mean glucose will be evaluated by comparing the mean glucose calculated from 7 days of CGM wear at the end of each study period.
|
12 weeks
|
|
Mean glucose time in range
大体时间：12 weeks
|
Mean glucose time in range (70-140 mg/dL) assessed by a continuous glucose monitor (CGM) expressed as minutes per day.
The between-condition difference in mean glucose time in range will be evaluated by comparing the mean glucose time in range from 7 days of CGM wear at the end of each study period.
|
12 weeks
|
|
Glycemic variability
大体时间：12 weeks
|
Glycemic variability assessed by a continuous glucose monitor (CGM) expressed as the coefficient of variability.
The between-condition difference in glycemic variability will be evaluated by comparing the glycemic variability calculated from 7 days of CGM wear at the end of each study period.
|
12 weeks
|
|
Change in homeostatic model of insulin resistance (HOMA-IR)
大体时间：12 weeks
|
HOMA-IR will be calculated as (fasting insulin μIU/mL × fasting glucose mg/dL) / 405.
Change in HOMA-IR will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
|
12 weeks
|
|
Difference in ambulatory processing speed
大体时间：12 weeks
|
Ambulatory processing speed assessed by ecological momentary assessment (EMA) administered Symbol Search, expressed as median response time correct.
The between-condition difference in ambulatory processing speed will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.
|
12 weeks
|
|
Difference in ambulatory working memory
大体时间：12 weeks
|
Ambulatory working memory assessed by ecological momentary assessment (EMA) administered Grid Memory, expressed as number of correct dots.
The between-condition difference in ambulatory working memory will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.
|
12 weeks
|
|
Difference in ambulatory attention
大体时间：12 weeks
|
Ambulatory attention assessed by ecological momentary assessment (EMA) administered Multiple Object Tracking expressed as number of correct dots.
The between-condition difference in ambulatory attention will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.
|
12 weeks
|
|
Change in body weight
大体时间：12 weeks
|
Change in body weight expressed as kg.
Change in body weight will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
|
12 weeks
|
|
Difference in hunger
大体时间：12 weeks
|
Hunger assessed by ecological momentary assessment (EMA) administered visual analog scale (scored 0-100).
The between-condition difference in hunger will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.
|
12 weeks
|
|
Difference in satiety
大体时间：12 weeks
|
Satiety assessed by ecological momentary assessment (EMA) administered visual analog scale (scored 0-100).
The between-condition difference in satiety will be evaluated by comparing mean values from 7 days of EMA at the end of each study period.
|
12 weeks
|
|
Change in total cholesterol
大体时间：12 weeks
|
Change in fasting serum total cholesterol expressed as mg/dL.
Change in total cholesterol will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
|
12 weeks
|
|
Change in LDL-cholesterol
大体时间：12 weeks
|
Change in fasting serum LDL-cholesterol calculated with the Martin-Hopkins equation expressed as mg/dL.
Change in LDL-cholesterol will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
|
12 weeks
|
|
Change in triglycerides
大体时间：12 weeks
|
Change in fasting serum triglycerides expressed as mg/dL.
Change in triglycerides will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
|
12 weeks
|
|
Change in HDL-cholesterol
大体时间：12 weeks
|
Change in fasting serum HDL-cholesterol expressed as mg/dL.
Change in HDL-cholesterol will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
|
12 weeks
|
|
Change in non-HDL cholesterol
大体时间：12 weeks
|
Change in fasting serum non-HDL cholesterol expressed as mg/dL.
Change in non-HDL cholesterol will be calculated as the mean of the post-condition day 1 and day 2 testing values minus the mean of the pre-condition day 1 and day 2 testing values.
|
12 weeks
|
|
Change in central systolic and diastolic blood pressure
大体时间：12 weeks
|
Change in central blood pressure measured using a SphymoCor Xcel (Atcor Medical) expressed as mmHg.
Change in systolic and diastolic blood pressure will be calculated as the post-condition value minus the pre-condition value and expressed as mmHg.
|
12 weeks
|
|
Change in peripheral systolic and diastolic blood pressure
大体时间：12 weeks
|
Change in peripheral blood pressure measured using a SphymoCor Xcel (Atcor Medical) expressed as mmHg.
Change in systolic and diastolic blood pressure will be calculated as the post-condition value minus the pre-condition value and expressed as mmHg.
|
12 weeks
|
|
Change in carotid-femoral pulse wave velocity
大体时间：12 weeks
|
Change in carotid-femoral pulse wave velocity (PWV) measured using a SphymoCor Xcel (Atcor Medical) expressed as m/s.
Change in PWV will be calculated as the post-condition value minus the pre-condition value and expressed as m/s.
|
12 weeks
|
|
Change in diet quality
大体时间：12 weeks
|
Assessed from a 24-hour recall completed prior to the beginning of each study period and at the end of each study period.
Diet quality will be calculated according to the Healthy Eating Index-2020 (HEI).
Change in HEI will be calculated at the post-condition value minus the pre-condition value
|
12 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference in microbiota composition
大体时间：12 weeks
|
Microbiota composition assessed by 16S rRNA sequencing.
The between-condition difference in microbiota composition will be evaluated by alpha and beta diversity and taxa profile at the end of each study period.
|
12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2027年1月18日
初级完成 (估计的)
2028年10月31日
研究完成 (估计的)
2028年10月31日
研究注册日期
首次提交
2026年7月14日
首先提交符合 QC 标准的
2026年7月15日
首次发布 (实际的)
2026年7月20日
研究记录更新
最后更新发布 (实际的)
2026年7月20日
上次提交的符合 QC 标准的更新
2026年7月15日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- PB
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
De-identified individual participant data will be deposited into an open access repository once results from all pre-specified primary and secondary outcomes are published.
IPD 共享时间框架
The SAP and protocol will be posted on clinicaltrials.gov
prior to enrollment commencing.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.