Post Prandial Inflammation MarkersNCT01729793
Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal
A study testing Digestive Enzyme #2 in people with Post Prandial Inflammation Markers, run by National Enzyme Company at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Prandial Inflammation Markers
- What is being tested?
- Digestive Enzyme #2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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.
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- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Post Prandial Inflammation Markers
- Being tested
- Digestive Enzyme #2, Placebo
- Keywords
- TNFalpha, IL6, postprandial, digestive, inflammation, IL1beta, CRP, CBC, ESR
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digestive Enzyme #2Dietary supplement
Also called NEC formula #C372
Contains dietary supplement proteases, lipases and carbohydrases
PlaceboOther
Also called NEC formula #C373
Capsule containing microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Digestive Enzyme #2 | Active comparator | A proprietary blend of dietary supplement enzymes in a capsule Receives: Dietary Supplement: Digestive Enzyme #2 |
| Placebo | Placebo comparator | Capsule identical to active arm containing only microcrystalline cellulose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNF-alpha blood level change from time 0
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
Measured: 0, 45 minutes, 2 hours and 4 hours
IL-1beta blood level change from time 0
Aliquots will be taken at time 0 (pre-meal) and the remainder post-meal.
Measured: 0, 45 minutes, 2 hours and 4 hours
IL-6 Blood Level change from time 0
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
Measured: 0, 45 minutes, 2 hours, 4 hours
hsCRP Blood Level change from time 0
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
Measured: 0, 45 minutes, 2 hours, 4 hours
CBC Panel change from time 0
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
Measured: 0, 4 hours
ESR blood test change from time 0
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
Measured: 0, 4 hours
Secondary outcomes (1)
Questionaire: Gastrointestinal Symptoms
The questionaire to assess gastrointestinal symptoms associated with gastrointestinal disturbances will be administered.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Prandial Inflammation MarkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Enzyme Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dale Wilson, MD, Study director, KGK Synergize
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729793
- Sponsor's protocol ID
- NEC-001
- Status last verified
- Nov 2012
- First submitted
- 14 Nov 2012
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal
- ClinicalTrials.gov ID
- NCT01729793
- Acronym / sponsor ID
- NEC-001
- Conditions
- Post Prandial Inflammation Markers
- Keywords
- TNFalpha, IL6, postprandial, digestive, inflammation, IL1beta, CRP, CBC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Enzyme CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digestive Enzyme #2 | Active comparator | Dietary Supplement: Digestive Enzyme #2A proprietary blend of dietary supplement enzymes in a capsule |
| Placebo | Placebo comparator | Other: PlaceboCapsule identical to active arm containing only microcrystalline cellulose |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digestive Enzyme #2Also: NEC formula #C372Contains dietary supplement proteases, lipases and carbohydrases | Dietary supplement | Digestive Enzyme #2 |
| PlaceboAlso: NEC formula #C373Capsule containing microcrystalline cellulose | Other | Placebo |
Primary outcome
TNF-alpha blood level change from time 0
Time frame: 0, 45 minutes, 2 hours and 4 hours
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
IL-1beta blood level change from time 0
Time frame: 0, 45 minutes, 2 hours and 4 hours
Aliquots will be taken at time 0 (pre-meal) and the remainder post-meal.
IL-6 Blood Level change from time 0
Time frame: 0, 45 minutes, 2 hours, 4 hours
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
hsCRP Blood Level change from time 0
Time frame: 0, 45 minutes, 2 hours, 4 hours
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
CBC Panel change from time 0
Time frame: 0, 4 hours
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
ESR blood test change from time 0
Time frame: 0, 4 hours
Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
1 secondary outcome
Questionaire: Gastrointestinal Symptoms
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dale Wilson, MD study director
KGK Synergize
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digestive Enzyme #2 in people with Post Prandial Inflammation Markers, run by National Enzyme Company at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TNF-alpha blood level change from time 0 (time frame: 0, 45 minutes, 2 hours and 4 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.