Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal
26 november 2012 uppdaterad av: National Enzyme Company
A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal
The primary objective of the study is to assess the efficacy of Digestive Enzyme Blend #2, a digestive enzyme dietary supplement product, on markers indicative of inflammation after a meal.
The markers will be assessed by blood levels tumor necrosis factor alpha (TNF-alpha), interleukin-1 beta (IL-1beta), interleukin-6 (IL-6), and high sensitivity C-reactive protein (hsCRP) at times 0, 45 minutes, 2 hours and 4 hours post-meal.
A full complete blood count (CBC)and an erythrocyte sedimentation rate (ESR) blood test will also be conducted at times 0 and 4 hours post-meal.
In addition, a questionaire on Gastrointestinal symptoms will be administered 4 hours post-meal.
The study hypothesis is that some or all of these potential markers of inflammation will increase following the meal, and the amount of increase in inflammation will be attenuated when a digestive enzyme is consumed with the meal compared to the placebo.
In addition, it is hypothesized that levels of gastric discomfort as assessed by the questionaire will be reduced with the digestive enzyme compared to the placebo.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The primary objective of the study is to assess the efficacy of Digestive Enzyme Blend #2, a digestive enzyme dietary supplement product, on markers indicative of inflammation after a meal.
The study design is a randomized, double-blind, placebo-controlled, cross-over type study.
The markers will be assessed by blood levels TNF-alpha, IL-1beta, IL-6, and hsCRP at times 0, 45 minutes, 2 hours and 4 hours post-meal.
A full blood CBC panel and an ESR blood test will also be conducted at times 0 and 4 hours post-meal.
In addition, a questionaire on Gastrointestinal symptoms will be administered 4 hours post-meal.
The study hypothesis is that some or all of these potential markers of inflammation will increase following the meal, and the amount of increase in inflammation will be attenuated when a digestive enzyme is consumed with the meal compared to the placebo.
In addition, it is hypothesized that levels of gastric discomfort as assessed by the questionaire will be reduced with the digestive enzyme compared to the placebo.
Studietyp
Interventionell
Inskrivning (Förväntat)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ontario
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London, Ontario, Kanada, N6A 5R8
- KGK Synergize Inc.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
19 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- If female, not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgical with >1 year since last menstruation). OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
- Healthy as determined by laboratory results, medical history and physical exam
- Agrees to comply with study protocols
- Has given voluntary, written, informed consent to participate in the study -
Exclusion Criteria:
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
- Gastrointestinal lesions/ulcer, diabetes, or any condition requiring the use of prescribed medications for treatment
- Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
- History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable.
- History of bleeding disorders, or significant blood loss in the past 3 months
- Use of blood thinning medications.
- Use of anti-inflammatory medications, including over-the-counter pain relievers within the past 14 days.
- Use of prescription medication (other than birth control), vitamins, minerals or other natural health products within the past 3 days. .
- Alcohol use >2 standard alcoholic drinks per day and/or alcohol or drug abuse within the past year
- Allergy or sensitivity to study supplement ingredients, study meal ingredients or allergy or sensitivity to yeasts or molds/fungi.
- Participation in a clinical research trial within 30 days prior to randomization
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Use of fish oil supplements within 10 days of randomization and during the trial
Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
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Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Digestive Enzyme #2
A proprietary blend of dietary supplement enzymes in a capsule
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Contains dietary supplement proteases, lipases and carbohydrases
Andra namn:
|
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Placebo-jämförare: Placebo
Capsule identical to active arm containing only microcrystalline cellulose
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Capsule containing microcrystalline cellulose
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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TNF-alpha blood level change from time 0
Tidsram: 0, 45 minutes, 2 hours and 4 hours
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Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
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0, 45 minutes, 2 hours and 4 hours
|
|
IL-1beta blood level change from time 0
Tidsram: 0, 45 minutes, 2 hours and 4 hours
|
Aliquots will be taken at time 0 (pre-meal) and the remainder post-meal.
|
0, 45 minutes, 2 hours and 4 hours
|
|
IL-6 Blood Level change from time 0
Tidsram: 0, 45 minutes, 2 hours, 4 hours
|
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
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0, 45 minutes, 2 hours, 4 hours
|
|
hsCRP Blood Level change from time 0
Tidsram: 0, 45 minutes, 2 hours, 4 hours
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Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
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0, 45 minutes, 2 hours, 4 hours
|
|
CBC Panel change from time 0
Tidsram: 0, 4 hours
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Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
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0, 4 hours
|
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ESR blood test change from time 0
Tidsram: 0, 4 hours
|
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
|
0, 4 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Questionaire: Gastrointestinal Symptoms
Tidsram: 4 hours
|
The questionaire to assess gastrointestinal symptoms associated with gastrointestinal disturbances will be administered.
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4 hours
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Dale Wilson, MD, KGK Synergize
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2012
Primärt slutförande (Förväntat)
1 december 2012
Avslutad studie (Förväntat)
1 december 2012
Studieregistreringsdatum
Först inskickad
14 november 2012
Först inskickad som uppfyllde QC-kriterierna
14 november 2012
Första postat (Uppskatta)
20 november 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 november 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 november 2012
Senast verifierad
1 november 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NEC-001
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .