Clinical trial NCT01877057: Protected Pea Protein Extract and Satiety Hormone Release
Official title: Assessment of the Effects of Gastric Degradation-protected Pea Protein Extract on Mucosal Satiety Hormone Release by Human Duodenal Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Pea protein
Satiety hormone
Ussing Chamber
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The increasing prevalence of overweight and obesity among the population contributes to increased incidences of chronic metabolic diseases. Healthcare costs related to these diseases are rising; prevention or delay of onset of disorders associated with overweight is needed. Food ingestion exerts a transient suppressive effect on appetite and further food intake by releasing gastrointestinal hormones. Proteins have been shown to be more satiating than carbohydrates and fat. Intraduodenal administration (via a naso-duodenal intubation) of pea protein has been shown to reduce food intake and increase satiety hormone levels in humans, in contrast to orally dosed (unprotected) pea protein. In the present study we aim to investigate the effects of human gastric fluid on the degradability of five different protected pea protein products. Further, in an ex vivo experiment on freshly obtained human duodenum tissue applying Ussing chamber technology; we aim to investigate the intestinal satiety hormone release by the five different prototypes. The prototype that is less degraded by human gastric fluid and is most effective in intestinal satiety hormone release will be used in a future clinical trial.


Eligibility criteria: Inclusion Criteria:

* Healthy men/women
* BMI between 18 and 25 kg/m2
* Consistently stable body weight for at least 6 months (± 2 kg)

Exclusion Criteria:

* Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L);
* Gastroenterological diseases or abdominal surgery (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgment of the principle investigator);
* Cardiovascular diseases, cancer, liver or kidney malfunction, auto-immune diseases, disease with a life expectancy shorter than 5 years;
* Abuse of products; alcohol (\>20 alcoholic consumptions per week) and drugs
* Smoking
* Plans to lose weight or following a hypocaloric diet;
* Use of any medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing;
* Regular use of laxation products;
* Use of antibiotics in the 90 days prior to the start of study.
* Administration of 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
* Known pregnancy, lactation (checked by a pregnancy test before start of study)
* Blood donation within 3 months before study period
* Self-admitted HIV-positive state

Primary outcomes:
measure: To measure the release of satiety hormones (CCK, PYY, GLP-1) by intestinal mucosa in respons to five different protected pea protein extracts.
timeFrame: In Ussing Chamber at baseline
measure: To measure the release of satiety hormones (CCK, PYY, GLP-1) by intestinal mucosa in respons to five different protected pea protein extracts.
timeFrame: In Ussing Chamber after 240 minutes
Secondary outcomes:
measure: To measure the degradability of the different prototypes by human gastric fluid, tested in an in vitro setting.
timeFrame: At baseline
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Department of Internal Medicine, Division of Gastroenterology-Hepatology
name: A.A.M. Masclee, Professor
role: PRINCIPAL_INVESTIGATOR
References: