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Cardiometabolic & Cognitive Effects of Peanut Butter in Prediabetes

15. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

56

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Kristina Petersen, PhD
  • Telefonní číslo: +1 814 865 7206
  • E-mail: kup63@psu.edu

Studijní záloha kontaktů

  • Jméno: Stacey Meily
  • Telefonní číslo: +1 814 863 8622
  • E-mail: sas117@psu.edu

Studijní místa

  • Spojené státy
    • Pennsylvania
      • University Park, Pennsylvania, Spojené státy, 16802
        • The Pennsylvania State University
        • Kontakt:
          • Kristina Petersen, PhD
          • Telefonní číslo: +1 814-865 7206
          • E-mail: kup63@psu.edu

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: Peanut butter
Intake of 43 g/day of peanut butter as part of breakfast (or the first meal of the day)
Jiný: Usual diet
Continue intake of usual diet.
Aktivní komparátor: 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).
Jiný: Peanut butter
Intake of 43 g/day of peanut butter as part of breakfast (or the first meal of the day)
Jiný: Usual diet
Continue intake of usual diet.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in HbA1c
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in fasting glucose
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Difference in microbiota composition
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Penn State University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

18. ledna 2027

Primární dokončení (Odhadovaný)

31. října 2028

Dokončení studie (Odhadovaný)

31. října 2028

Termíny zápisu do studia

První předloženo

14. července 2026

První předloženo, které splnilo kritéria kontroly kvality

15. července 2026

První zveřejněno (Aktuální)

20. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PB

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

The SAP and protocol will be posted on clinicaltrials.gov prior to enrollment commencing.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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