To assess the degradability of five different protected pea protein products by human gastric fluid, and to assess the effects of different protected pea protein extracts on the intestinal satiety hormone release.
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
Synonym
Health condition
Obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the effect of five different protected pea protein
extracts on intestinal satiety hormone release (CCK, GLP-1, PYY).
Secondary outcome
Secondary endpoint is the degradability of the different prototypes by human
gastric fluid, tested in an in vitro setting.
Background 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.
Study objective
To assess the degradability of five different protected pea protein products by
human gastric fluid, and to assess the effects of different protected pea
protein extracts on the intestinal satiety hormone release.
Study design
In vitro gastric fluid experiment and ex vivo Ussing chamber experiment.
Intervention
Participants will have to visit the study site once. For the gastric fluid
experiment the participant will receive a nasogastric catheter and about 75 mL
gastric fluid will be aspirated. On another occasion, a gastroduodenoscopy
tissue will be performed to obtain duodenum tissue samples for the Ussing
chamber experiments.
Study burden and risks
There are several burdens volunteers can experience during this study. After
the screening visit, participants will have to invest approximately 1 hour in
the study. They will have to visit the MUMC+ in total 2 times. Furthermore, a
subject that participates in the gastric fluid experiment will receive once a
nasogastric catheter. The risk of stomach perforation is generally considered
as nil. The subjects will perceive mild discomfort during the placement of the
catheter. For the Ussing chamber experiment, a gastroduodenoscopy will be
performed and biopsies will be taken. This procedure bears a small risk
(<0.0002%) risk of bowel perforation and bleeding at the biopsy sites in
general clinical use, however the risk in the present study is expected to be
much smaller, because instead of patients, healthy subjects without intestinal
disease will be investigated.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Men/women, healthy human beings, age 18-70 years, BMI between 18.5 and 24.9 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42988.068.13 |
| Other | Volgt, registratie in clinicaltrials.gov |