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OpenTrials
Completed

NCT Number: NCT02376270

Pectin, Aging and Intestinal Barrier Function

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pectin

Dietary Supplement

This group will receive 7.5 grams of pectin supplements twice daily for four weeks.

Maltodextrin

Dietary Supplement

This group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks.

Primary outcomes

  1. Sugar recovery in urine, as indicator of intestinal permeability

    Time frame: Change from Baseline to after 4 weeks of intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Effects of Pectin on Aging-related Changes in Intestinal Barrier Function, Immune Function and Microbial Composition

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 3, 2015
Registry last updated
Jul 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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