Pectin, Aging and Intestinal Barrier Function

Maastricht University Medical Centre (MUMC)

Status and phase

Completed

Phase 4

Conditions

Healthy Elderly

Healthy Young Adults

Treatments

Dietary Supplement: Pectin

Dietary Supplement: Maltodextrin

Study type

Interventional

Funder types

Other

Identifiers

NCT02376270

143055

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.