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Completed

NCT Number: NCT02500069

Location Specific Differences in Intestinal Brake Activation

The appearance of intact macronutrients in the small intestine can result in the activation of an intestinal brake; a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. The researchers will investigate the effects of intraduodenal, intrajejunal and intralileal infusion of casein (protein) on ad libitum food intake, satiation and in vivo release of the gut satiety peptides CCK, PYY and GLP-1 and glucose and insulin.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6003, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  • Based on medical history and previous examination, no gastrointestinal complaints can be defined.
  • Age between 18 and 65 years. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
  • BMI between 18 and 25 kg/m2)
  • Weight stable over at least the last 6 months (≤5% weight change)

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

  • History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
  • Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
  • 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 180 days prior to the study
  • Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
  • Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
  • Pregnancy, lactation
  • Excessive alcohol consumption (>20 alcoholic consumptions per week)
  • Smoking
  • Blood donation within 3 months before the study period
  • Self-admitted HIV-positive state
  • Weight <60kg
  • Evidence of casein or sucrose hypersensitivity
  • Participation in any other study in which radiation was used, within 12 months before the study period

Treatment and study plan

Placebo

Other

infusion of tap water in all regions (duodenum, jejunum and ileum)

Casein (in duodenum)

Other

infusion of protein in duodenum

Casein (in jejunum)

Other

infusion of protein in jejunum

Casein (in ileum)

Other

infusion of protein in ileum

Primary outcomes

  1. To measure ad libitum food intake at the end of the test day

    Time frame: 1 test day

    Food intake measurement in kcal

Secondary outcomes

  1. VAS scores for hunger and satiety

    Time frame: 1 test day

    Visual analogue scale for hunger and satiety in mm (0-100 mm scale)

  2. GI peptides

    Time frame: 1 test day

    Measurement of GI peptide release during protein infusion (CCK, GLP-1, PYY, insulin and glucose)

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Effect of Intestinal Brake Activation at Different Locations in the Gut on Food Intake and Hormone Release

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jul 16, 2015
Registry last updated
Jul 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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