Location Specific Differences in Intestinal Brake Activation

NCT02500069 | Completed DMC

• 1 other identifier: METC-14-3-006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ileal Brake; Satiety; Overweight; Obesity; Overeating

Outcome Measures

Primary Outcomes (1)

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

  Food intake measurement in kcal

  1 test day

Secondary Outcomes (2)

• VAS scores for hunger and satiety

  1 test day

• GI peptides

  1 test day

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Tap water infusion in all three locations (duodenum, jejunum and ileum)

Other: placebo

Duodenum

EXPERIMENTAL

Infusion of casein in duodenum

Other: Casein (in duodenum)

Jejunum

EXPERIMENTAL

Infusion of casein in jejunum

Other: Casein (in jejunum)

Ileum

EXPERIMENTAL

Infusion of casein in ileum

Other: Casein (in ileum)

Interventions

placebo OTHER

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

Placebo

Casein (in duodenum) OTHER

infusion of protein in duodenum

Duodenum

Casein (in jejunum) OTHER

infusion of protein in jejunum

Jejunum

Casein (in ileum) OTHER

infusion of protein in ileum

Ileum

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6003, Netherlands

Location

Related Publications (1)

• van Avesaat M, Ripken D, Hendriks HF, Masclee AA, Troost FJ. Small intestinal protein infusion in humans: evidence for a location-specific gradient in intestinal feedback on food intake and GI peptide release. Int J Obes (Lond). 2017 Feb;41(2):217-224. doi: 10.1038/ijo.2016.196. Epub 2016 Nov 4.

  PMID: 27811949 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Hyperphagia

Interventions

Caseins

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoproteins

Study Officials

• A Masclee, Prof. dr.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: July 16, 2015
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

NL (1)