Protected Pea Protein Extract and Satiety Hormone Release

NCT ID: NCT01877057

Last Updated: 2015-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-07-31

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.

Conditions

Obesity; Overweight

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Saturn

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Saturn

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Protected pea protein

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Bouke Salden

Medical Degree

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

A.A.M. Masclee, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Division of Gastroenterology-Hepatology

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

133001

Identifier Type: -

Identifier Source: org_study_id