Cardiometabolic & Cognitive Effects of Peanut Butter in Prediabetes
Peanut Butter Glycemic Control, Cognition and Cardiovascular Health
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Kristina Petersen, PhD
- Puhelinnumero: +1 814 865 7206
- Sähköposti: kup63@psu.edu
Tutki yhteystietojen varmuuskopiointi
- Nimi: Stacey Meily
- Puhelinnumero: +1 814 863 8622
- Sähköposti: sas117@psu.edu
Opiskelupaikat
-
-
Pennsylvania
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University Park, Pennsylvania, Yhdysvallat, 16802
- The Pennsylvania State University
-
Ottaa yhteyttä:
- Kristina Petersen, PhD
- Puhelinnumero: +1 814-865 7206
- Sähköposti: kup63@psu.edu
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Yksittäinen
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
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Kokeellinen: 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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Active Comparator: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in HbA1c
Aikaikkuna: 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.
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12 weeks
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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in fasting glucose
Aikaikkuna: 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
|
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Change in fasting insulin
Aikaikkuna: 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
|
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Mean glucose
Aikaikkuna: 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.
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12 weeks
|
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Mean glucose time in range
Aikaikkuna: 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
Aikaikkuna: 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
|
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Change in homeostatic model of insulin resistance (HOMA-IR)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
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Difference in ambulatory attention
Aikaikkuna: 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
|
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Change in body weight
Aikaikkuna: 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
|
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Difference in hunger
Aikaikkuna: 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
|
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Difference in satiety
Aikaikkuna: 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
|
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Change in total cholesterol
Aikaikkuna: 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
|
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Change in LDL-cholesterol
Aikaikkuna: 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
Aikaikkuna: 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
|
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Change in HDL-cholesterol
Aikaikkuna: 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
|
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Change in non-HDL cholesterol
Aikaikkuna: 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
|
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Change in central systolic and diastolic blood pressure
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
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Change in diet quality
Aikaikkuna: 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
|
Muut tulostoimenpiteet
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Difference in microbiota composition
Aikaikkuna: 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
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Yhteistyökumppanit ja tutkijat
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Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
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Ensimmäinen toimitettu, joka täytti QC-kriteerit
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Ensimmäinen Lähetetty (Todellinen)
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Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
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Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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