Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 98 for:    grams | maltodextrin

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

Tracking Information
First Submitted Date  ICMJE February 19, 2015
First Posted Date  ICMJE March 3, 2015
Last Update Posted Date July 15, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
Sugar recovery in urine, as indicator of intestinal permeability [ Time Frame: Change from Baseline to after 4 weeks of intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02376270 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pectin, Aging and Intestinal Barrier Function
Official Title  ICMJE The Effects of Pectin on Aging-related Changes in Intestinal Barrier Function, Immune Function and Microbial Composition
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Healthy Young Adults
  • Healthy Elderly
Intervention  ICMJE
  • Dietary Supplement: Pectin
    This group will receive 7.5 grams of pectin supplements twice daily for four weeks.
  • Dietary Supplement: Maltodextrin
    This group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks.
Study Arms  ICMJE
  • Experimental: Pectin
    This group will receive 7.5 grams of pectin supplements twice daily for four weeks.
    Intervention: Dietary Supplement: Pectin
  • Placebo Comparator: Maltodextrin
    This group group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks.
    Intervention: Dietary Supplement: Maltodextrin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2016)
100
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2015)
96
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02376270
Other Study ID Numbers  ICMJE 143055
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: A.A.M. Masclee, Professor Department of Internal Medicine, Division of Gastroenterology-Hepatology
PRS Account Maastricht University Medical Center
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP