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Protected Pea Protein Extract and Satiety Hormone Release

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Saturn
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Pea protein, Satiety hormone, Ussing Chamber

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Saturn

Arm Description

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.

Outcomes

Primary Outcome Measures

To measure the release of satiety hormones (CCK, PYY, GLP-1) by intestinal mucosa in respons to five different protected pea protein extracts.
To measure the release of satiety hormones (CCK, PYY, GLP-1) by intestinal mucosa in respons to five different protected pea protein extracts.

Secondary Outcome Measures

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.

Full Information

First Posted
June 5, 2013
Last Updated
July 6, 2015
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01877057
Brief Title
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Pea protein, Satiety hormone, Ussing Chamber

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saturn
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Saturn
Other Intervention Name(s)
Protected pea protein
Primary Outcome Measure Information:
Title
To measure the release of satiety hormones (CCK, PYY, GLP-1) by intestinal mucosa in respons to five different protected pea protein extracts.
Time Frame
In Ussing Chamber at baseline
Title
To measure the release of satiety hormones (CCK, PYY, GLP-1) by intestinal mucosa in respons to five different protected pea protein extracts.
Time Frame
In Ussing Chamber after 240 minutes
Secondary Outcome Measure Information:
Title
To measure the degradability of the different prototypes by human gastric fluid, tested in an in vitro setting.
Description
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.
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A.A.M. Masclee, Professor
Organizational Affiliation
Department of Internal Medicine, Division of Gastroenterology-Hepatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

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Protected Pea Protein Extract and Satiety Hormone Release

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