Healthy Young AdultsPhase 4NCT02376270
Pectin, Aging and Intestinal Barrier Function
A Phase 4 study testing Pectin and Maltodextrin in people with Healthy Young Adults and Healthy Elderly, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The population is aging worldwide, which requires more attention to health needs and leads to a dramatic increase in health care costs. Prevention or delay of onset of disorders associated with aging is needed. Dietary intake of pectin, a dietary fiber, may have beneficial effects on gut health parameters, i.e. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults, Healthy Elderly
- What is being tested?
- Pectin and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2015to May 2016
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Based on medical history and previous self-admitted examination, no gastrointestinal complaints can be defined.
- Age between 18 - 40 years and 65 - 75 years.
- Body Mass Index (BMI) between 20 and 30 kg/m2. Normal BMI has been chosen because obesity is associated with an altered microbial composition and increased intestinal permeability.
Who cannot join
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
- Use of proton-pump inhibitors, nonsteroidal anti-inflammatory drugs and/or vitamin supplementation, within 14 days prior to testing. Use of other medication will be reviewed by a medical doctor, who will decide on in- or exclusion based on the drug(s) used.
- Administration of probiotic or prebiotic supplements, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 90 days prior to the study
- Use of antibiotics in the 90 days prior to the study.
- Abdominal surgery interfering with gastrointestinal function, upon judgment of the principle investigator).
- Pregnancy, lactation.
Show all 11Show fewer
- Excessive alcohol consumption (>20 alcoholic consumptions per week).
- Smoking.
- Blood donation within 3 months before or after the study period.
- Self-admitted human immunodeficiency virus-positive state.
- History of side effects towards intake of prebiotic supplements.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
About this study
Official title: The Effects of Pectin on Aging-related Changes in Intestinal Barrier Function, Immune Function and Microbial Composition
The population is aging worldwide, which requires more attention to health needs and leads to a dramatic increase in health care costs. Prevention or delay of onset of disorders associated with aging is needed. Dietary intake of pectin, a dietary fiber, may have beneficial effects on gut health parameters, i.e. intestinal barrier function, immune function and microbial composition. As intestinal barrier function may be compromised in the elderly we will investigate whether the effects of pectin on selected parameters of gut health differ between young vs. older individuals. The primary objective of this study is to investigate the effects of aging on pectin-induced changes in intestinal permeability. Furthermore, this study has seven secondary objectives. This study conforms to a randomized, double-blind and placebo-controlled design including two parallel arms.The study population consists of Healthy human volunteers (male and female), 18-40 and 65-75 years old, BMI 20-30 kg/m2. One group will receive 7.5 grams of pectin supplements twice daily for four weeks. A second group will receive 7.5 grams of placebo supplements twice daily for four weeks. Before and after the supplementation period, several measurements will take place. The main study parameter is the change in urinary sugar excretion ratio before and after the intervention period.
- Conditions
- Healthy Young Adults, Healthy Elderly
- Being tested
- Pectin, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PectinDietary supplement
This group will receive 7.5 grams of pectin supplements twice daily for four weeks.
MaltodextrinDietary supplement
This group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pectin | Experimental | This group will receive 7.5 grams of pectin supplements twice daily for four weeks. Receives: Dietary Supplement: Pectin |
| Maltodextrin | Placebo comparator | This group group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sugar recovery in urine, as indicator of intestinal permeability
Measured: Change from Baseline to after 4 weeks of intervention
Secondary outcomes (16)
Tight junction structure and proteins in colonic biopsies, as indicator of intestinal barrier function
Measured: After 4 weeks of intervention
Ussing chamber experiments in colonic biopsies, as indicator of intestinal barrier function
Measured: After 4 weeks of intervention
Histology in colonic biopsies, as indicator of intestinal barrier function
Measured: After 4 weeks of intervention
MiR-29a in colonic biopsies, as indicator of intestinal barrier function
Measured: After 4 weeks of intervention
Zonulin in blood plasma, as indicator of intestinal barrier function
Measured: Change from Baseline to after 4 weeks of intervention
Immune infiltration cells in colonic biopsies, as indicator of immune system performance
Measured: After 4 weeks of intervention
T-cells and Natural Killer cells in blood plasma, as indicator of immune system performance
Measured: Change from Baseline to after 4 weeks of intervention
Cytokines Interleukin-10 and Interleukin-12 in blood plasma, as indicator of immune system performance
Measured: Change from Baseline to after 4 weeks of intervention
C-reactive protein in blood serum, as indicator of immune system performance
Measured: Change from Baseline to after 4 weeks of intervention
Secretory Immunoglobulin A in blood serum, as indicator of immune system performance
Measured: Change from Baseline to after 4 weeks of intervention
Microbial composition in luminal content and feces
Measured: Change from Baseline to after 4 weeks of intervention
Short-chain fatty acids in luminal content and feces, as indicator of microbial function
Measured: Change from Baseline to after 4 weeks of intervention
Volatile organic compounds in exhaled air, as indicator for metabolite production
Measured: Change from Baseline to after 4 weeks of intervention
Symptom diary questionnaire, as indicator of digestive parameters
Measured: Change from three days prior to the supplementation period to three days during the last week of the supplementation period
Stool frequency and consistency questionnaire, as indicator of digestive parameters
Measured: Change from Baseline to after 4 weeks of intervention
Gastrointestinal Symptom Rating Scale questionnaire, as indicator of digestive parameters
Measured: Change from Baseline to after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young AdultsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A.A.M. Masclee, Professor, Principal investigator, Department of Internal Medicine, Division of Gastroenterology-Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376270
- Sponsor's protocol ID
- 143055
- Status last verified
- Oct 2015
- First submitted
- 19 Feb 2015
- Last updated
- 15 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pectin on Aging-related Changes in Intestinal Barrier Function, Immune Function and Microbial Composition
- ClinicalTrials.gov ID
- NCT02376270
- Acronym / sponsor ID
- 143055
- Conditions
- Healthy Young Adults, Healthy Elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Mar 2015 (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 population is aging worldwide, which requires more attention to health needs and leads to a dramatic increase in health care costs. Prevention or delay of onset of disorders associated with aging is needed. Dietary intake of pectin, a dietary fiber, may have beneficial effects on gut health parameters, i.e. intestinal barrier function, immune function and microbial composition. As intestinal barrier function may be compromised in the elderly we will investigate whether the effects of pectin on selected parameters of gut health differ between young vs. older individuals. The primary objective of this study is to investigate the effects of aging on pectin-induced changes in intestinal permeability. Furthermore, this study has seven secondary objectives. This study conforms to a randomized, double-blind and placebo-controlled design including two parallel arms.The study population consists of Healthy human volunteers (male and female), 18-40 and 65-75 years old, BMI 20-30 kg/m2. One group will receive 7.5 grams of pectin supplements twice daily for four weeks. A second group will receive 7.5 grams of placebo supplements twice daily for four weeks. Before and after the supplementation period, several measurements will take place. The main study parameter is the change in urinary sugar excretion ratio before and after the intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectin | Experimental | Dietary Supplement: PectinThis group will receive 7.5 grams of pectin supplements twice daily for four weeks. |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinThis group group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Based on medical history and previous self-admitted examination, no gastrointestinal complaints can be defined.
- Age between 18 - 40 years and 65 - 75 years.
- Body Mass Index (BMI) between 20 and 30 kg/m2. Normal BMI has been chosen because obesity is associated with an altered microbial composition and increased intestinal permeability.
Key exclusion criteria (11 listed)
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
- Use of proton-pump inhibitors, nonsteroidal anti-inflammatory drugs and/or vitamin supplementation, within 14 days prior to testing. Use of other medication will be reviewed by a medical doctor, who will decide on in- or exclusion based on the drug(s) used.
- Administration of probiotic or prebiotic supplements, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 90 days prior to the study
- Use of antibiotics in the 90 days prior to the study.
- Abdominal surgery interfering with gastrointestinal function, upon judgment of the principle investigator).
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 |
|---|---|---|
| PectinThis group will receive 7.5 grams of pectin supplements twice daily for four weeks. | Dietary supplement | Pectin |
| MaltodextrinThis group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks. | Dietary supplement | Maltodextrin |
Primary outcome
Sugar recovery in urine, as indicator of intestinal permeability
Time frame: Change from Baseline to after 4 weeks of intervention
16 secondary outcomes
Tight junction structure and proteins in colonic biopsies, as indicator of intestinal barrier function
Time frame: After 4 weeks of intervention
Ussing chamber experiments in colonic biopsies, as indicator of intestinal barrier function
Time frame: After 4 weeks of intervention
Histology in colonic biopsies, as indicator of intestinal barrier function
Time frame: After 4 weeks of intervention
MiR-29a in colonic biopsies, as indicator of intestinal barrier function
Time frame: After 4 weeks of intervention
Zonulin in blood plasma, as indicator of intestinal barrier function
Time frame: Change from Baseline to after 4 weeks of intervention
Immune infiltration cells in colonic biopsies, as indicator of immune system performance
Time frame: After 4 weeks of intervention
T-cells and Natural Killer cells in blood plasma, as indicator of immune system performance
Time frame: Change from Baseline to after 4 weeks of intervention
Cytokines Interleukin-10 and Interleukin-12 in blood plasma, as indicator of immune system performance
Time frame: Change from Baseline to after 4 weeks of intervention
C-reactive protein in blood serum, as indicator of immune system performance
Time frame: Change from Baseline to after 4 weeks of intervention
Secretory Immunoglobulin A in blood serum, as indicator of immune system performance
Time frame: Change from Baseline to after 4 weeks of intervention
Microbial composition in luminal content and feces
Time frame: Change from Baseline to after 4 weeks of intervention
Short-chain fatty acids in luminal content and feces, as indicator of microbial function
Time frame: Change from Baseline to after 4 weeks of intervention
Volatile organic compounds in exhaled air, as indicator for metabolite production
Time frame: Change from Baseline to after 4 weeks of intervention
Symptom diary questionnaire, as indicator of digestive parameters
Time frame: Change from three days prior to the supplementation period to three days during the last week of the supplementation period
Stool frequency and consistency questionnaire, as indicator of digestive parameters
Time frame: Change from Baseline to after 4 weeks of intervention
Gastrointestinal Symptom Rating Scale questionnaire, as indicator of digestive parameters
Time frame: Change from Baseline to after 4 weeks of intervention
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 15 Jul 2016.
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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.
A.A.M. Masclee, Professor principal investigator
Department of Internal Medicine, Division of Gastroenterology-Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pectin and Maltodextrin in people with Healthy Young Adults and Healthy Elderly, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 11 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 15 Jul 2016. 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sugar recovery in urine, as indicator of intestinal permeability (time frame: Change from Baseline to after 4 weeks of intervention). 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 15 Jul 2016.