Protected Pea Protein Extract and Satiety Hormone Release

Obesity Clinical Trial

Official title:

Assessment of the Effects of Gastric Degradation-protected Pea Protein Extract on Mucosal Satiety Hormone Release by Human Duodenal Tissue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877057
• Other study ID #: 133001
• Status: Completed
• Phase: N/A
• First received: June 5, 2013
• Last updated: July 6, 2015
• Start date: March 2013
• Est. completion date: July 2013

Study information

• Verified date: July 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Saturn

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the release of satiety hormones (CCK, PYY, GLP-1) by intestinal mucosa in respons to five different protected pea protein extracts.		In Ussing Chamber at baseline	No
Primary	To measure the release of satiety hormones (CCK, PYY, GLP-1) by intestinal mucosa in respons to five different protected pea protein extracts.		In Ussing Chamber after 240 minutes	No
Secondary	To measure the degradability of the different prototypes by human gastric fluid, tested in an in vitro setting.	First, in vitro digestion will be conducted for the gastro-resistent protein in order to calculate the degree of hydrolysis of food proteins by o-phthaldialdehyde method (OPA). First, OPA solution and serine standard solution will be prepared. Samples are analyzed after the in vitro digestion. Measurements are made on 96 well microplates, each sample is analyzed twice. The absorbance is measured on spectrophotometer. The degree of hydrolysis corresponds to the amount of amino groups released during enzymatic digestion.	At baseline	No