Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pectin, Aging and Intestinal Barrier Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376270
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : July 15, 2016
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy Young Adults Healthy Elderly Dietary Supplement: Pectin Dietary Supplement: Maltodextrin Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Pectin on Aging-related Changes in Intestinal Barrier Function, Immune Function and Microbial Composition
Study Start Date : March 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Pectin

Arm Intervention/treatment
Experimental: Pectin
This group will receive 7.5 grams of pectin supplements twice daily for four weeks.
Dietary Supplement: Pectin
This group will receive 7.5 grams of pectin supplements twice daily for four weeks.

Placebo Comparator: Maltodextrin
This group group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks.
Dietary Supplement: Maltodextrin
This group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks.




Primary Outcome Measures :
  1. Sugar recovery in urine, as indicator of intestinal permeability [ Time Frame: Change from Baseline to after 4 weeks of intervention ]

Secondary Outcome Measures :
  1. Tight junction structure and proteins in colonic biopsies, as indicator of intestinal barrier function [ Time Frame: After 4 weeks of intervention ]
  2. Ussing chamber experiments in colonic biopsies, as indicator of intestinal barrier function [ Time Frame: After 4 weeks of intervention ]
  3. Histology in colonic biopsies, as indicator of intestinal barrier function [ Time Frame: After 4 weeks of intervention ]
  4. MiR-29a in colonic biopsies, as indicator of intestinal barrier function [ Time Frame: After 4 weeks of intervention ]
  5. Zonulin in blood plasma, as indicator of intestinal barrier function [ Time Frame: Change from Baseline to after 4 weeks of intervention ]
  6. Immune infiltration cells in colonic biopsies, as indicator of immune system performance [ Time Frame: After 4 weeks of intervention ]
  7. 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 ]
  8. 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 ]
  9. C-reactive protein in blood serum, as indicator of immune system performance [ Time Frame: Change from Baseline to after 4 weeks of intervention ]
  10. Secretory Immunoglobulin A in blood serum, as indicator of immune system performance [ Time Frame: Change from Baseline to after 4 weeks of intervention ]
  11. Microbial composition in luminal content and feces [ Time Frame: Change from Baseline to after 4 weeks of intervention ]
  12. 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 ]
  13. Volatile organic compounds in exhaled air, as indicator for metabolite production [ Time Frame: Change from Baseline to after 4 weeks of intervention ]
  14. 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 ]
  15. Stool frequency and consistency questionnaire, as indicator of digestive parameters [ Time Frame: Change from Baseline to after 4 weeks of intervention ]
  16. Gastrointestinal Symptom Rating Scale questionnaire, as indicator of digestive parameters [ Time Frame: Change from Baseline to after 4 weeks of intervention ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376270


Locations
Layout table for location information
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: A.A.M. Masclee, Professor Department of Internal Medicine, Division of Gastroenterology-Hepatology

Layout table for additonal information
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02376270     History of Changes
Other Study ID Numbers: 143055
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: October 2015