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Acute Effects of Grape Seed Extract on Insulin Sensitivity and Oxidative Stress and Inflammation Markers. (GSE2)

26 luglio 2021 aggiornato da: Clinical Nutrition Research Center, Illinois Institute of Technology

Effect of Grape Seed Extract on Modulation of Oxidative Stress/ Inflammation/ Insulin Sensitivity Induced by High Fat-carbohydrate Meal in Healthy Human Subjects

The proposed study aims to investigate that consumption of grape seed extract (GSE) would improve antioxidant status and impaired insulin action following consumption of a pro-oxidative high carbohydrate, high fat (HCHF) meal in healthy human subjects.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study is a single-center, double blind, placebo-controlled, randomized, 2-arm, 2-sequence, crossover study

A planned sample size of 15 will be recruited into the study. This study will require one initial screening, one pre-study visit, two 6-hour study visits. The study will take 2-5 weeks per subject to complete.

The initial screening visit will provide subjects an Institutional Review Board approved consent document and determine subject eligibility through BMI calculated from height and weight measurements, vital signs, fasting blood glucose test (finger prick), lipid profiles (3 ml blood sampling via a butterfly needle device) and completion of a questionnaire related to general eating, health, and exercise habits.

If subjects are willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend day) will be instructed at the initial screening visit and collected at the pre-study visit to assess subjects' usual dietary intake pattern. After reviewing food records, subjects will be instructed to avoid any grapes, grape products, berries, berry products throughout the study and strictly follow a limited polyphenolic diet for 3 days prior to each 6-hr study visit, while maintaining their usual diet pattern and physical activity. Prior to each study visit, subject will be advised to have the same or similar dinner meal to control the second meal effect from food and beverage intake of the night before each study visit.

Subjects will arrive at the center after ~10 hours overnight fasting, well hydrated and rested. Each study visit will require blood draws throughout the visit. After pre-study procedures (height, weight, waist circumferences, vital sign, and fasting blood glucose test), a registered nurse will place a catheter in subject's arm for the purpose of multiple blood sample collections and collect fasting blood sample. During each study visit, subject will take one of the two capsules right after fasting blood draw), based on randomization sequences (either 1 grape seed extract capsule or 1 placebo capsule). One hour after administration of the assigned capsule, blood samples will be collected. And a standard high carbohydrate and high fat breakfast meal will be served and subject will have blood draws at designated time up to 5 hours.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

13

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60616
        • Clinical Nutrition Research Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Aged between 20 to 65 years old
  • Body Mass Index (BMI) range from 18.5 to 24.9 kg/m2; exception BMI 18.5 to 23 kg/m2 for Asian population
  • Fasting blood glucose concentration < 110 mg/dL
  • Fasting LDL-cholesterol <180 mg/dL
  • Fasting Total cholesterol and Fasting Triglycerides < 250 mg/dL
  • Weight stable: not gained or lost weight +/- 5 lbs in previous 3 months
  • Non-smokers
  • No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
  • Not taking any medications or dietary supplements that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, fish oil, probiotics, grape seed supplement, etc…If anti-inflammation and/or antibiotic medications/supplements are taken, subjects may qualify if go off these medications/supplements 30 days wash-out before entering the study.
  • Able to provide informed consent
  • Able to comply and perform the procedures requested by the protocol

Exclusion Criteria:

  • Past smokers: abstinence for less than 2 years
  • Men and women who smoke
  • Men and women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compound or any their stated ingredients.
  • Men and women known to have/diagnosed with diabetes mellitus
  • Men and women who have fasting blood glucose concentrations ≥110 mg/dL
  • Men and women who have uncontrolled blood pressure >140 mmHg/90 mmHg
  • Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries.
  • Men and women with cancer other than non-melanoma skin cancer in previous 5 years.
  • Men and women who are taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplements, anti-inflammation, lipid lowering medication. Subjects may choose to go off dietary supplements (requires 30 days washout).
  • Men and women who are taking blood pressure lowering medication that may interfere the outcomes of the study; e.g. diuretics.
  • Men and women who have donated blood within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
  • Men and women who are vegetarians or vegans
  • Substance (alcohol or drug) abuse within the last 2 years.
  • Excessive coffee and tea consumers (> 4 cups/day)
  • Men and women who do excessive exercise regularly or athlete
  • Unstable weight: gained or lost weight +/- 5 lbs in previous 3 months
  • Women who are known to be pregnant or who are intending to become pregnant over the course of the study
  • Women who are lactating

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Active Capsule
Grape Seed Extract Capsule: 300 mg
Integratore alimentare: Active Capsule
GSE Capsule
Comparatore placebo: Placebo Capsule
Placebo Capsule: Maltodextrin
Integratore alimentare: Placebo Capsule
Placebo Capsule

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in insulin and glucose concentrations over 6 hours after the Grape Seed Extract Capsule administration
Lasso di tempo: 6 hours
The timing influence of the Grape Seed Extract administration on insulin and glucose concentrations in relative to the standard meal intake (1 hour before the meal and 5 hours after the meal)
6 hours

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in oxidative stress markers and inflammatory markers over 6 hours after the Grape Seed Extract Capsule administration
Lasso di tempo: 6 hours
The timing influence of grape seed extract administration on oxidative stress markers and inflammatory markers in relative to the standard meal intake (1 hour before the meal and 5 hours after the meal)
6 hours

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Clinical Nutrition Research Center, Illinois Institute of Technology

Investigatori

  • Cattedra di studio: Britt Burton-Freeman, Ph.D, MS, Institute for Food Safety and Health

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 ottobre 2013

Completamento primario (Effettivo)

1 agosto 2014

Completamento dello studio (Effettivo)

30 agosto 2014

Date di iscrizione allo studio

Primo inviato

21 novembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

25 novembre 2013

Primo Inserito (Stima)

26 novembre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 luglio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 luglio 2021

Ultimo verificato

1 luglio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2013-114

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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