Cardiometabolic & Cognitive Effects of Peanut Butter in Prediabetes
2026년 7월 15일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
56
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Kristina Petersen, PhD
- 전화번호: +1 814 865 7206
- 이메일: kup63@psu.edu
연구 연락처 백업
- 이름: Stacey Meily
- 전화번호: +1 814 863 8622
- 이메일: sas117@psu.edu
연구 장소
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Pennsylvania
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University Park, Pennsylvania, 미국, 16802
- The Pennsylvania State University
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연락하다:
- Kristina Petersen, PhD
- 전화번호: +1 814-865 7206
- 이메일: kup63@psu.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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Intake of 43 g/day of peanut butter as part of breakfast (or the first meal of the day)
Continue intake of usual diet.
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활성 비교기: 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).
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Intake of 43 g/day of peanut butter as part of breakfast (or the first meal of the day)
Continue intake of usual diet.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in HbA1c
기간: 12 weeks
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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.
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12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in fasting glucose
기간: 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.
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12 weeks
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Change in fasting insulin
기간: 12 weeks
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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.
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12 weeks
|
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Mean glucose
기간: 12 weeks
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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.
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12 weeks
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Mean glucose time in range
기간: 12 weeks
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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.
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12 weeks
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Glycemic variability
기간: 12 weeks
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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.
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12 weeks
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Change in homeostatic model of insulin resistance (HOMA-IR)
기간: 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.
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12 weeks
|
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Difference in ambulatory processing speed
기간: 12 weeks
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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.
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12 weeks
|
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Difference in ambulatory working memory
기간: 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.
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12 weeks
|
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Difference in ambulatory attention
기간: 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.
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12 weeks
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Change in body weight
기간: 12 weeks
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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.
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12 weeks
|
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Difference in hunger
기간: 12 weeks
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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.
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12 weeks
|
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Difference in satiety
기간: 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.
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12 weeks
|
|
Change in total cholesterol
기간: 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.
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12 weeks
|
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Change in LDL-cholesterol
기간: 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.
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12 weeks
|
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Change in triglycerides
기간: 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.
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12 weeks
|
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Change in HDL-cholesterol
기간: 12 weeks
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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.
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12 weeks
|
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Change in non-HDL cholesterol
기간: 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
기간: 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
기간: 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
기간: 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.
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12 weeks
|
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Change in diet quality
기간: 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
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12 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in microbiota composition
기간: 12 weeks
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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.
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12 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2027년 1월 18일
기본 완료 (추정된)
2028년 10월 31일
연구 완료 (추정된)
2028년 10월 31일
연구 등록 날짜
최초 제출
2026년 7월 14일
QC 기준을 충족하는 최초 제출
2026년 7월 15일
처음 게시됨 (실제)
2026년 7월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 15일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
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개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
The SAP and protocol will be posted on clinicaltrials.gov
prior to enrollment commencing.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
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미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .