Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal
26. november 2012 oppdatert 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.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
-
London, Ontario, Canada, N6A 5R8
- KGK Synergize Inc.
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
19 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Digestive Enzyme #2
A proprietary blend of dietary supplement enzymes in a capsule
|
Contains dietary supplement proteases, lipases and carbohydrases
Andre navn:
|
|
Placebo komparator: Placebo
Capsule identical to active arm containing only microcrystalline cellulose
|
Capsule containing microcrystalline cellulose
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
TNF-alpha blood level change from time 0
Tidsramme: 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-1beta blood level change from time 0
Tidsramme: 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
Tidsramme: 0, 45 minutes, 2 hours, 4 hours
|
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
|
0, 45 minutes, 2 hours, 4 hours
|
|
hsCRP Blood Level change from time 0
Tidsramme: 0, 45 minutes, 2 hours, 4 hours
|
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
|
0, 45 minutes, 2 hours, 4 hours
|
|
CBC Panel change from time 0
Tidsramme: 0, 4 hours
|
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
|
0, 4 hours
|
|
ESR blood test change from time 0
Tidsramme: 0, 4 hours
|
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
|
0, 4 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Questionaire: Gastrointestinal Symptoms
Tidsramme: 4 hours
|
The questionaire to assess gastrointestinal symptoms associated with gastrointestinal disturbances will be administered.
|
4 hours
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Dale Wilson, MD, KGK Synergize
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2012
Primær fullføring (Forventet)
1. desember 2012
Studiet fullført (Forventet)
1. desember 2012
Datoer for studieregistrering
Først innsendt
14. november 2012
Først innsendt som oppfylte QC-kriteriene
14. november 2012
Først lagt ut (Anslag)
20. november 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. november 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. november 2012
Sist bekreftet
1. november 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NEC-001
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