A Phase 4 interventional study of Pectin and Maltodextrin in Healthy Young Adults and Healthy Elderly, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-15.
Sponsored by Maastricht University Medical Center · Phase 4, Interventional, and Prevention
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.
Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 121 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will receive 7.5 grams of pectin supplements twice daily for four weeks.
Dietary Supplement: Pectin
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 pectin supplements twice daily for four weeks.
This group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks.
Sugar recovery in urine, as indicator of intestinal permeability
Time frame: Change from Baseline to after 4 weeks of intervention
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
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Maastricht University Medical Center