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Protected Pea Protein Extract and Satiety Hormone Release

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ClinicalTrials.gov Identifier: NCT01877057
Recruitment Status : Completed
First Posted : June 13, 2013
Last Update Posted : July 7, 2015
Sponsor:
Information provided by (Responsible Party):
Bouke Salden, Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Dietary Supplement: Saturn Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessment of the Effects of Gastric Degradation-protected Pea Protein Extract on Mucosal Satiety Hormone Release by Human Duodenal Tissue
Study Start Date : March 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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 Name: Protected pea protein




Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. To measure the degradability of the different prototypes by human gastric fluid, tested in an in vitro setting. [ Time Frame: At baseline ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877057


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: A.A.M. Masclee, Professor Department of Internal Medicine, Division of Gastroenterology-Hepatology

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Responsible Party: Bouke Salden, Medical Degree, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01877057     History of Changes
Other Study ID Numbers: 133001
First Posted: June 13, 2013    Key Record Dates
Last Update Posted: July 7, 2015
Last Verified: July 2015

Keywords provided by Bouke Salden, Maastricht University Medical Center:
Pea protein
Satiety hormone
Ussing Chamber

Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs