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Impact of Peanut Consumption on Stress, Immune Function, Inflammation, and Cardiovascular Health in High-Stress Individuals

2026年9月8日 更新者：USDA, Western Human Nutrition Research Center

Effects of Peanut Consumption on Physiological and Psychosocial Stress, Circulating Immune Cell Status, Markers of Inflammation and Cardiovascular Disease Risk, and Gastrointestinal Health in High-Stress Individuals

The purpose of this research is to determine whether peanut consumption improves indicators of cardiovascular disease (CVD) risk in human subjects following the consumption of study foods.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

The overall goal of the proposed study is to determine whether peanut consumption improves indices of cardiovascular disease (CVD) risk in human subjects with high levels of perceived chronic stress. Chronic stress is a growing public health concern and is associated with adverse health outcomes, including CVD. Stress, experienced when a person feels that environmental, physiological, or psychosocial demands tax or exceed their adaptive capacity, triggers a coordinated response from the sympathetic nervous system (SNS) and hypothalamic- pituitary- adrenal (HPA) axis increasing blood pressure, driving systemic inflammation, and affecting the immune system by accelerating the output of disease-promoting immune cells from bone marrow.

研究の種類

介入

入学 (推定)

70

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • California
      • Davis、California、アメリカ、95616
        • 募集
        • Western Human Nutrition Research Center
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Ryan Snodgrass, PhD
        • 副調査官：
          • Danielle Lemay, PhD
        • 副調査官：
          • Mary Kable, PhD
        • 副調査官：
          • Kevin Laugero, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

  • Males and females
  • 18-65 years old
  • BMI ≥ 18.5 kg/m2 and ≤ 39.9 kg/ m2
  • Recruitment will be based on Perceived Stress Scale - 4 (PSS-4) score

Exclusion Criteria:

  • Less than 18 and over 65 years old
  • Pregnant or lactating women
  • Adults who rely on prescription medication that may influence study variables, apart from birth control
  • BMI < 18.5 kg/m2 and > 39.9 kg/m2
  • Smokers who currently use tobacco- or marijuana-containing products including e-cigarettes, vape pens, pod mods, tanks, and electronic nicotine delivery devices (ENDS)
  • Habitual consumption of nuts, nut butters, nut powders, nut side dishes, nut bars or other nut products
  • Known food allergies (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, sesame, corn) due to samples not prepared in a hypoallergenic environment
  • Currently living in close contact with individuals who have an allergy to peanuts, in order to avoid exposing these individuals to an allergen
  • Self-reported history of difficulties with blood drawing procedures including prior fainting or dizziness, or veins assessed as not suitable for four separate venipunctures by licensed phlebotomist

  • Diagnosed active chronic diseases for which the individual is currently taking daily medication, including but not limited to:

    • Diabetes mellitus, cardiovascular disease, cancer, gastrointestinal disorders, kidney disease, liver disease, bleeding disorders, asthma, autoimmune disorders, hypertension, osteoporosis
  • Recent minor surgery (within 4 weeks) or major surgery (within 16 weeks)
  • Known gallbladder disease or history of cholecystectomy
  • History of gastrointestinal surgery, including gastric bypass surgery or resection
  • Diagnosis of irritable bowel syndrome
  • Recent antibiotic therapy (within 4 weeks)
  • Recent hospitalization (within 4 weeks)
  • Current participation in another research study
  • Has HIV/AIDS, hepatitis, or another disease that affects the immune system
  • Gives regular blood donations and is unwilling to stop during the study
  • Blood Pressure ≥ 140 mmHg systolic or 90 mmHg diastolic
  • Current diagnoses of an eating disorder (ex. anorexia, bulimia, etc.)
  • High - very high triglyceride levels: ≥ 300 mg/dL
  • Adults who are unable to consent, individuals who are not yet adults (infants, children and teenagers), pregnant women and prisoners will be excluded from participation in the study
  • Participants who are unwilling to collect and transport urine, stool and saliva samples
  • Abnormal hemoglobin and/or hematocrit levels
  • Abnormal liver function (defined as liver enzymes that are >200% of upper limit (ALT upper limit is 43 U/L or Aspartate transaminase (AST) upper limit is 54 U/L)
  • Unwillingness to discontinue probiotic, prebiotic, fiber, or other supplements (except RDA-level vitamin and mineral supplements) during the study
  • Unwilling to consume study foods
  • Alcohol consumption > 20 g/day

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：基礎科学
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Peanut Intervention followed by corn chips Intervention
Participants will be asked to consume 42g of peanuts with skin daily for 4 weeks. Following a 4-week washout, the participant will then be asked to consume 45g of corn chips daily for 4 weeks.
他の：Peanuts, roasted, salted with skins
42g roasted salted peanuts with skins consumed daily
他の：Isocaloric food
Corn chips (45g)
実験的：Corn chip Intervention followed by Peanut Intervention
The participant will be asked to consume 45g of corn chips daily for 4 weeks. Following a 4-week washout, the participant will be then asked to consume 42g of peanuts with skin daily for 4 weeks.
他の：Peanuts, roasted, salted with skins
42g roasted salted peanuts with skins consumed daily
他の：Isocaloric food
Corn chips (45g)

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in psychosocial stress over time
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks

The PSS-10 will be administered 4 times during the study. The 10-item Perceived Stress Scale (PSS-10) is a validated, standard instrument used to assess subjective perceptions of chronic psychological stress (i.e., excessive demands, insufficient coping resources, and a perceived lack of control).

The minimum score is 0 and the maximum score is 40. Higher scores indicate greater severity of psychosocial stress.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of allostatic load following dietary interventions
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, cumulative physiological stress load, also referred to as allostatic load (AL), will be calculated. AL will be derived from 12-h overnight urinary cortisol, norepinephrine, and epinephrine levels (corrected for urinary creatinine levels), resting systolic and diastolic blood pressure, and overnight fasted waist-to-hip ratio, fasting serum levels of high-sensitivity C-reactive protein (hs-CRP), cholesterol, HDL-cholesterol, fasting plasma dehydroepiandrosterone sulfate (DHEA-S), and whole blood glycohemoglobin (HbA1c).
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of monocyte gene expression
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Total monocytes isolated from human peripheral blood mononuclear cells (PBMCs) at baseline and post-intervention will be collected, and their global gene expression will be analyzed by ribonucleic acid (RNA) sequencing.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of cytokine and interferon production in PBMCs
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Monocytes isolated from human peripheral blood mononuclear cells (PBMCs) will be challenged with and without toll-like receptor ligands to assess cytokine and interferon production in low- and high-stress subjects at baseline and after intervention.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of cytotoxicity of peripheral natural killer cells
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
The cytotoxicity of peripheral natural killer (NK) cells isolated from subject's peripheral blood mononuclear cells (PBMCs) of low- and high-stress individuals at baseline and after intervention will be assessed using an ex vivo cytotoxicity assay with human erythroleukemic cell line (K562) target cells.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of interferon-gamma
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Interferon-gamma (IFN-γ) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of tumor necrosis factors alpha and beta
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Tumor necrosis factors alpha and beta (TNF-α, TNF-β) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of interleukins
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
A panel of interleukins: (IL) (IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of fibroblast growth factor
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Fibroblast growth factor (FGF) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of granulocyte-macrophage colony-stimulating factor
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Granulocyte-macrophage colony-stimulating factor (GM-CSF) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery:
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of thymus and activation-regulated chemokine
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Thymus and activation-regulated chemokine (TARC). will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of macrophage inflammatory proteins-1 alpha and beta
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Macrophage inflammatory proteins-1 alpha and beta (MIP-1α, MIP-1β) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of macrophage-derived chemokine
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Macrophage-derived chemokine (MDC) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of monocyte chemoattractant proteins-1 and -4
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Monocyte chemoattractant proteins-1 and -4 (MCP-1, MCP-4) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of interferon gamma-induced protein-10
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Interferon gamma-induced protein-10 (IP-10) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of eotaxin and eotaxin-3
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Eotaxin and eotaxin-3 will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of C-reactive protein
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
C-reactive protein (CRP) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of intercellular adhesion molecule-1
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Intercellular adhesion molecule-1 (ICAM-1) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of placental growth factor
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Placental growth factor (PlGF) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of serum amyloid A
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum amyloid A (SAA) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of angiopoietin-1 receptor
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Angiopoietin-1 receptor (Tie-2) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of vascular cell adhesion molecule-1
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Vascular cell adhesion molecule-1 (VCAM-1) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of vascular endothelial growth factors A, C, and D
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Vascular endothelial growth factors A, C, and D (VEGF-A, VEGF-C, VEGF-D) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of vascular endothelial growth factor receptor-1
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Vascular endothelial growth factor receptor-1 (VEGFR-1/Flt-1) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of monocyte phenotype
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
Classical monocytes, intermediate monocytes, and non-classical monocytes, will be identified by leukocyte common antigen (CD45+), Low-density lipoprotein receptor-related protein 1 (CD91+), cluster of differentiation 14 (CD14), cluster of differentiation 16 (CD16), and cluster of differentiation 3 (lin-CD3)/cluster of differentiation 66b (CD66b)/neural cell adhesion molecule (CD56)/cluster of differentiation 19 (CD19) using flow cytometry.
Baseline, 4 weeks, 8 weeks, 12 weeks
Change from baseline of monocyte functional profile
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
Cellular activation of classical monocytes, intermediate monocytes, and non-classical monocytes will be assessed by expression of cluster of differentiation 11b (CD11b) and cluster of differentiation 163 (CD163).
Baseline, 4 weeks, 8 weeks, 12 weeks
Change from baseline of natural killer cell phenotype
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
Natural killer (NK) cells will be identified by CD45+, cluster of differentiation 56+ (CD56+), and lin-CD3/CD66b/CD14/CD19 using flow cytometry.
Baseline, 4 weeks, 8 weeks, 12 weeks
Change from baseline of natural killer cell functional profile
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
Natural killer (NK) cell maturation status and cytotoxic potential via CD16, cluster of differentiation 57 (CD57), killer cell lectin-like receptor K1 (NKG2D), and cluster of differentiation 159 (NKG2A) will be analyzed using flow cytometry.
Baseline, 4 weeks, 8 weeks, 12 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Changes in stool consistency
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to confirm the stool consistency reported by the study subject.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in stool metrics
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to determine the whole stool weight.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in bowel movement frequency
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
During the week prior to each intervention and the final week of each intervention, participants will maintain a stool diary for recording frequency of bowel movements.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in Gastrointestinal (GI) symptoms
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
During the week prior to each intervention and the final week of each intervention, a short GI Symptoms Questionnaire will be administered via Qualtrics to record occurrence of gastric symptoms.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut microbial diversity
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to determine the microbial community composition by 16-subunit ribosomal ribonucleic acid (16S rRNA) amplicon sequence analysis.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in stool short chain fatty acids
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to measure the amount of fecal short chain fatty acids (SCFAs).
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut inflammatory markers
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to measure the inflammatory marker, fecal calprotectin.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in salivary cortisol
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks

To assess waking and diurnal cortisol fluctuations, saliva will be collected at home at selected times upon waking and before bedtime. The waking saliva sample must be collected within 10-15 minutes of waking. Following the waking sample, participants will be asked to collect additional saliva samples at 15, 30, 45, and 60 minutes after the waking sample, as well as a saliva sample before bedtime.

In total, participants will return 24 saliva samples (6 per visit) throughout the study.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary cortisol levels
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, 12-hour overnight urinary cortisol will be measured.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary epinephrine levels
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, 12-hour overnight urinary epinephrine levels will be measured.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary norepinephrine levels
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, 12-hour overnight urinary norepinephrine levels will be measured.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary creatinine levels
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, 12-hour overnight urinary creatinine levels will be measured.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in resting blood pressure
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Research team will collect resting blood pressure (systolic and diastolic) in mmHg (millimeters of mercury).
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in dietary intake
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Dietary intake will be assessed by using the Automated Self-Administered 24-hour (ASA24®) dietary assessment tool, a web-based tool that enables multiple, automatically coded, self-administered 24-hour recalls. Three dietary recalls will be conducted in the week preceding and the final week of each intervention period, for a total of 12, 24-hour dietary recalls.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in Body Weight
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Research team will collect weight in kg.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in white blood cell count
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
White blood cell (WBC) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in lymphocyte count
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Lymphocyte (LY) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in monocyte count
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Monocyte (MO) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in neutrophil granulocyte count
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Neutrophil granulocyte (NE) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in eosinophil count
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Eosinophil (EO) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in basophil count
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Basophil (BA) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of triglycerides
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Lipid-related markers including triglycerides will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of total cholesterol
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Lipid-related markers including total cholesterol will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of HDL-cholesterol
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Lipid-related markers including HDL-cholesterol (HDL-C) will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of LDL-cholesterol
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Lipid-related markers including LDL-cholesterol (LDL-C) will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of glucose
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
Plasma glucose will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut transit time
時間枠：Baseline, 4 weeks, 8 weeks, and 12 weeks
During the week prior to each intervention and the final week of each intervention, participants will consume a muffin containing blue food dye. Participants will log the date and time of consumption, and will log each bowel movement until stool color changes. This will be used to measure gut transit time.
Baseline, 4 weeks, 8 weeks, and 12 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

USDA, Western Human Nutrition Research Center

捜査官

  • 主任研究者：Ryan Snodgrass, PhD、United States Department of Agriculture - Western Human Nutrition Research Center

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2028年8月1日

研究の完了 (推定)

2028年8月1日

試験登録日

最初に提出

2025年8月4日

QC基準を満たした最初の提出物

2026年7月24日

最初の投稿 (実際)

2026年7月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月11日

QC基準を満たした最後の更新が送信されました

2026年9月8日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2280324

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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