Abdominal PainInflammagingNCT04450979
Study to Evaluate Bioactive Peptides' Effect on Digestive Discomfort Symptoms of the Elderly
A study testing Bioactive hydrolysate in people with Abdominal Pain, run by Nuritas Ltd.
Trial summary
This trial will investigate the potential of a bioactive peptide to reduce symptoms of digestive discomfort in a generally healthy elderly population. Participants will consume the bioactive peptide for 12 weeks and various measures indicating an improvement in health and well being will be taken throughout the trial. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Bioactive hydrolysate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 14 Jun 2016to 20 Jan 2017
- 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 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Be able to give written informed consent
- Be between 65 and 75 years of age (inclusive)
- Have symptoms of digestive pain \& discomfort
- Have a Fried Frailty score of <2
- Have a Short physical performance battery (SPPB) score of >5 and <10
- Have a Mini Mental State Exam (MMSE) score >24
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- Have low or moderate activity according to the IPAQ short form
- Have a BMI <30 kg/m2
- Be in good general health.
Who cannot join
- Are less than 65 and greater than 75 years of age
- Are severely immunocompromised (HIV positive, transplant Subject, on antirejection medications, on a steroid for >30 days.
- Have a diagnosis of Irritable Bowel Syndrome
- Is taking a high dose of statins and/or has changed had their dose modified in the previous 6 months
- Is experiencing muscle pain, soreness or muscle loss in the previous 6 months
- Has a history of drug and / or alcohol abuse at the time of enrolment
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- Has changed their dietary habit within the preceding month
- Has a known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease
- Subject currently involved in any other clinical trial or having participated in a trial within the preceding 90 days
- Has known allergy to components of the test product
- Use of anti-inflammatory steroid medications, anticoagulants, current/recent (3 months) history of anabolic steroid, corticosteroid or estrogen use, testosterone replacement therapy (ingestion, injection, or transdermal), or any anabolic steroid
- Has any concurrent medical or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements
About this study
Official title: A Randomised, Double-blinded, Parallel Group, Placebo-Controlled Study to Evaluate the Effects of a Bioactive Peptide on Symptoms of Digestive Discomfort in the Elderly
This trial will investigate the potential of a bioactive peptide to reduce symptoms of digestive discomfort in a generally healthy elderly population. Participants will consume the bioactive peptide for 12 weeks and various measures indicating an improvement in health and well being will be taken throughout the trial. It is believed that consumption of the study product will reduce the severity of digestive discomfort, reduce chronic inflammation, improve blood glucose metabolism and improve physical performance.
Read the detailed description
Forty subjects aged between 65 and 75 with self-reported symptoms of digestive discomfort will be randomised. Subjects will be randomised to receive either the Bioactive peptide or placebo for a total of 12 weeks.
Subjects will undergo an initial phone screen and will be asked questions regarding their age and their symptoms of digestive discomfort. Eligible subjects will be scheduled for a screening visit. The study will involve 5 visits over a 13 to 16 week period.
At the screening visit (Visit 1) the inclusion and exclusion criteria will be reviewed and the overall details of the study will be explained and informed consent obtained. Vitals and Medical history, demographic data and concomitant medication will be recorded.
Subjects will be asked questions relating to their digestive symptoms, including symptoms of abdominal pain, discomfort, bloating and flatulence. Subjects will complete the Digestive Symptom Frequency Questionnaire (DSFQ), the International Physical Activity Questionnaire (IPAQ) and the Mini-mental State Exam (MMSE) will be administered. The Fried Frailty score will be completed and the Short Physical Performance Battery (SPPB) test will be performed. A fasting blood sample (9mls) will be collected and haematology, biochemistry, glucose and blood lipids will be measured.
Subjects will be provided with a stool collection kit and instructions for collecting and storing. Subjects will collect a stool sample at home, within 24 hours of their next visit and bring it to the clinic at their next visit.
If the subject meets the eligibility criteria, they will be invited to participate in the study and will be given an appointment to return to the study site within 4 weeks for their baseline/week 0 visit.
Subjects will attend visit 2 fasting. The inclusion and exclusion criteria will be reviewed and eligibility for study entry confirmed. An Oral Glucose Tolerance Test will be performed. Haematology, biochemistry and blood lipids will also be measured.
A urine sample will be collected and also stored frozen for analysis of metabolites.
Vitals, anthropometric measurements, concomitant medication and any adverse events will be recorded and The Short Physical Performance Battery (SPPB) test will be performed.
Subjects will complete the Digestive Symptom Frequency Questionnaire and the hand-grip and chair-stand tests will be performed. A DEXA scan will be performed and muscle and fat mass recorded.
Subjects will be randomized to receive the Bioactive peptide or placebo and receive a 4 week supply of product and instructions for dosing. Subjects will be provided with a stool collection kit and instructions for collecting and storing. Subjects will collect a stool sample at home, within 24 hours of their next visit and bring it to the clinic at their next visit.
Subjects will return for visits at week 4, week 8 and week 12.
A similar regimen will be followed for visits at week 4, week 8 and week 12.
The site, investigator, protocol, informed consent form and any other pertinent documents for this study will be approved by: Cork Research Ethics Committee of the Cork Teaching Hospitals, Lancaster Hall, 6 Little Hanover Street, Cork.
The investigator is responsible for ensuring that all source documents (i.e. study and/or medical records) are completed and maintained according to the study protocol, Good Clinical Practice (GCP) and are available at the site.
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
ANCOVA Analysis of co-variance AUC Area Under the Plasma Concentration BMI Body mass index BP Blood pressure CI Confidence interval CRF Case Report Form CRO Contract Research Organization EFSA European Food Safety Authority GCP Good Clinical Practice GMP Good Manufacturing Practice HbAIc Glycated haemoglobin (A1c) ICH International Conference on Harmonization INCI The International Nomenclature of Cosmetic Ingredients ITT Intent-to-treat kDa Kilodalton kg Kilogram L Liter MCH Mean corpuscular hemoglobin MCHC Mean corpuscular hemoglobin concentration MCV Mean corpuscular volume MCPs Marine collagen peptides MedDRA Medical Dictionary for Regulatory Activities mITT Modified intention-to-treat mL Milliliter mmHg Millimeter of mercury mmol/mol Millimoles per mole OGTT Oral glucose tolerance test PPP Per protocol population RDW Red cell distribution width SAE Serious adverse event SAP Statistical analysis plan VLDL Very low-density lipoprotein WHO World Health Organisation
- Conditions
- Abdominal Pain
- Being tested
- Bioactive hydrolysate
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive hydrolysateDietary supplement
Participants given a bioactive vegetable hydrolysate to take one dose each morning and one dose each evening for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Bioactive hydrolysate | Active comparator | 20 g of hydrolysed rice protein Receives: Dietary Supplement: Bioactive hydrolysate |
| Placebo | Placebo comparator | 20 g micro crystalline cellulose Receives: Dietary Supplement: Bioactive hydrolysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digestive symptom frequency questionnaire
The primary endpoint is the difference between the change experienced over 12 weeks in the active group versus the change in the placebo group using the digestive symptom frequency questionnaire (DSFQ) at baseline and end of treatment
Measured: Baseline (week 0) and end of treatment (week 12)
Secondary outcomes (7)
To determine the effect of supplementation of a Bioactive Peptide on muscle mass
Muscle mass, measured by dual-energy x-ray absorptiometry (DXA) at weeks 0 and 12
Measured: Baseline (week 0) and week 12
To determine the effect of supplementation of a Bioactive Peptide on upper body muscle strength
Upper body muscle strength, measured by the hand-grip test
Measured: Baseline (weeks 0) and week 4, week 8 and week 12
To determine the effect of supplementation of a Bioactive Peptide on lower body muscle strength
Lower body muscle strength, measured by the chair stand test
Measured: Baseline (weeks 0) and week 4, week 8 and week 12
To determine the effect of supplementation of a Bioactive Peptide on physical performance
Short physical performance battery test score
Measured: Baseline (weeks 0) and week 12
To determine the effect of supplementation of a Bioactive Peptide on blood glucose
Glucose as measured by the Oral Glucose Tolerance Test
Measured: Baseline (weeks 0) and week 12
To determine the effect of supplementation of a Bioactive Peptide on blood markers of inflammation
Inflammatory cytokines (IL6 \& IL1R, CRP, TNF)
Measured: Baseline (weeks 0) and week 4, week 8 and week 12
To determine the effect of supplementation of a Bioactive Peptide on blood lipid
Lipids (Total cholesterol, LDL, HDL, Triglycerides
Measured: Baseline (weeks 0) and week 4, week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start14 Jun 2016
- Primary completion28 Oct 2016
- Study completion20 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuritas Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450979
- Sponsor's protocol ID
- AFCRO-063
- Acronym
- Inflammaging
- Status last verified
- Apr 2022
- First submitted
- 25 Jun 2020
- Last updated
- 14 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blinded, Parallel Group, Placebo-Controlled Study to Evaluate the Effects of a Bioactive Peptide on Symptoms of Digestive Discomfort in the Elderly
- ClinicalTrials.gov ID
- NCT04450979
- Acronym / sponsor ID
- Inflammaging / AFCRO-063
- Conditions
- Abdominal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nuritas LtdIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 28 Oct 2016 (actual)
- Study completion
- 20 Jan 2017 (actual)
- First posted
- 30 Jun 2020 (actual)
- 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.
This trial will investigate the potential of a bioactive peptide to reduce symptoms of digestive discomfort in a generally healthy elderly population. Participants will consume the bioactive peptide for 12 weeks and various measures indicating an improvement in health and well being will be taken throughout the trial. It is believed that consumption of the study product will reduce the severity of digestive discomfort, reduce chronic inflammation, improve blood glucose metabolism and improve physical performance.
Detailed description
Forty subjects aged between 65 and 75 with self-reported symptoms of digestive discomfort will be randomised. Subjects will be randomised to receive either the Bioactive peptide or placebo for a total of 12 weeks.
Subjects will undergo an initial phone screen and will be asked questions regarding their age and their symptoms of digestive discomfort. Eligible subjects will be scheduled for a screening visit. The study will involve 5 visits over a 13 to 16 week period.
At the screening visit (Visit 1) the inclusion and exclusion criteria will be reviewed and the overall details of the study will be explained and informed consent obtained. Vitals and Medical history, demographic data and concomitant medication will be recorded.
Subjects will be asked questions relating to their digestive symptoms, including symptoms of abdominal pain, discomfort, bloating and flatulence. Subjects will complete the Digestive Symptom Frequency Questionnaire (DSFQ), the International Physical Activity Questionnaire (IPAQ) and the Mini-mental State Exam (MMSE) will be administered. The Fried Frailty score will be completed and the Short Physical Performance Battery (SPPB) test will be performed. A fasting blood sample (9mls) will be collected and haematology, biochemistry, glucose and blood lipids will be measured.
Subjects will be provided with a stool collection kit and instructions for collecting and storing. Subjects will collect a stool sample at home, within 24 hours of their next visit and bring it to the clinic at their next visit.
If the subject meets the eligibility criteria, they will be invited to participate in the study and will be given an appointment to return to the study site within 4 weeks for their baseline/week 0 visit.
Subjects will attend visit 2 fasting. The inclusion and exclusion criteria will be reviewed and eligibility for study entry confirmed. An Oral Glucose Tolerance Test will be performed. Haematology, biochemistry and blood lipids will also be measured.
A urine sample will be collected and also stored frozen for analysis of metabolites.
Vitals, anthropometric measurements, concomitant medication and any adverse events will be recorded and The Short Physical Performance Battery (SPPB) test will be performed.
Subjects will complete the Digestive Symptom Frequency Questionnaire and the hand-grip and chair-stand tests will be performed. A DEXA scan will be performed and muscle and fat mass recorded.
Subjects will be randomized to receive the Bioactive peptide or placebo and receive a 4 week supply of product and instructions for dosing. Subjects will be provided with a stool collection kit and instructions for collecting and storing. Subjects will collect a stool sample at home, within 24 hours of their next visit and bring it to the clinic at their next visit.
Subjects will return for visits at week 4, week 8 and week 12.
A similar regimen will be followed for visits at week 4, week 8 and week 12.
The site, investigator, protocol, informed consent form and any other pertinent documents for this study will be approved by: Cork Research Ethics Committee of the Cork Teaching Hospitals, Lancaster Hall, 6 Little Hanover Street, Cork.
The investigator is responsible for ensuring that all source documents (i.e. study and/or medical records) are completed and maintained according to the study protocol, Good Clinical Practice (GCP) and are available at the site.
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
ANCOVA Analysis of co-variance AUC Area Under the Plasma Concentration BMI Body mass index BP Blood pressure CI Confidence interval CRF Case Report Form CRO Contract Research Organization EFSA European Food Safety Authority GCP Good Clinical Practice GMP Good Manufacturing Practice HbAIc Glycated haemoglobin (A1c) ICH International Conference on Harmonization INCI The International Nomenclature of Cosmetic Ingredients ITT Intent-to-treat kDa Kilodalton kg Kilogram L Liter MCH Mean corpuscular hemoglobin MCHC Mean corpuscular hemoglobin concentration MCV Mean corpuscular volume MCPs Marine collagen peptides MedDRA Medical Dictionary for Regulatory Activities mITT Modified intention-to-treat mL Milliliter mmHg Millimeter of mercury mmol/mol Millimoles per mole OGTT Oral glucose tolerance test PPP Per protocol population RDW Red cell distribution width SAE Serious adverse event SAP Statistical analysis plan VLDL Very low-density lipoprotein WHO World Health Organisation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioactive hydrolysate | Active comparator | Dietary Supplement: Bioactive hydrolysate20 g of hydrolysed rice protein |
| Placebo | Placebo comparator | Dietary Supplement: Bioactive hydrolysate20 g micro crystalline cellulose |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Be able to give written informed consent
- Be between 65 and 75 years of age (inclusive)
- Have symptoms of digestive pain \& discomfort
- Have a Fried Frailty score of <2
- Have a Short physical performance battery (SPPB) score of >5 and <10
Key exclusion criteria (12 listed)
- Are less than 65 and greater than 75 years of age
- Are severely immunocompromised (HIV positive, transplant Subject, on antirejection medications, on a steroid for >30 days.
- Have a diagnosis of Irritable Bowel Syndrome
- Is taking a high dose of statins and/or has changed had their dose modified in the previous 6 months
- Is experiencing muscle pain, soreness or muscle loss in the previous 6 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 |
|---|---|---|
| Bioactive hydrolysateParticipants given a bioactive vegetable hydrolysate to take one dose each morning and one dose each evening for the duration of the study. | Dietary supplement | Bioactive hydrolysate, Placebo |
Primary outcome
Digestive symptom frequency questionnaire
Time frame: Baseline (week 0) and end of treatment (week 12)
The primary endpoint is the difference between the change experienced over 12 weeks in the active group versus the change in the placebo group using the digestive symptom frequency questionnaire (DSFQ) at baseline and end of treatment
7 secondary outcomes
To determine the effect of supplementation of a Bioactive Peptide on muscle mass
Time frame: Baseline (week 0) and week 12
To determine the effect of supplementation of a Bioactive Peptide on upper body muscle strength
Time frame: Baseline (weeks 0) and week 4, week 8 and week 12
To determine the effect of supplementation of a Bioactive Peptide on lower body muscle strength
Time frame: Baseline (weeks 0) and week 4, week 8 and week 12
To determine the effect of supplementation of a Bioactive Peptide on physical performance
Time frame: Baseline (weeks 0) and week 12
To determine the effect of supplementation of a Bioactive Peptide on blood glucose
Time frame: Baseline (weeks 0) and week 12
To determine the effect of supplementation of a Bioactive Peptide on blood markers of inflammation
Time frame: Baseline (weeks 0) and week 4, week 8 and week 12
To determine the effect of supplementation of a Bioactive Peptide on blood lipid
Time frame: Baseline (weeks 0) and week 4, week 8 and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bioactive hydrolysate in people with Abdominal Pain, run by Nuritas Ltd.
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 9 inclusion and 12 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: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Digestive symptom frequency questionnaire (time frame: Baseline (week 0) and end of treatment (week 12)). 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 14 Apr 2022.