Protected Pea Protein Extract and Satiety Hormone Release

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

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 Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Dietary supplement: Saturn

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Saturn; For the different prototypes of pea protein extract used in this study pea protein NUTRALYS F85M or F85G, Acacia Gum 381A or 396I and water will be used.	Dietary supplement: Saturn; Other Names: Protected pea protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: June 5, 2013
• First Submitted That Met QC Criteria: June 11, 2013
• First Posted (ESTIMATE): June 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 7, 2015
• Last Update Submitted That Met QC Criteria: July 6, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Pea protein; Satiety hormone; Ussing Chamber
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 133001