Effect of Amino Acids and Sugar Alcohols on Satiation Peptides and Activation of Specific Brain Regions

Effect of Amino Acids and Sugar Alcohols on Release of Satiation Peptides and Activation of Specific Brain Regions in Normal Weight and Obese Subjects

With this study the investigators investigate the effects of amino acids (tryptophan, leucin) and sugar alcohols (xylitol, erythritol) on satiety mechanisms and brain activation.

Study Overview

• Status: Completed
• Conditions: Endocrine System Diseases
• Intervention / Treatment: Dietary supplement: 1.56 g L-Tryptophan; Dietary supplement: Tap water; Dietary supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate); Device: Nasogastric Tube; Dietary supplement: 1.56 g L-Leucine; Dietary supplement: 50 g Xylitol; Dietary supplement: 75 g Erythritol; Dietary supplement: 75 g Glucose

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy normal weight subjects with a body-mass index of 19.0-24.9
• Healthy obese subjects with a body-mass index of > 30
• Normal eating habits (no diets; no dietary changes; no special dietary habits such as vegetarian/vegan)
• Age 18-40 years
• Stable body weight for at least three months

Exclusion Criteria:

• Smoking
• Substance abuse
• Regular intake of medications (except for oral contraceptives)
• Medical or psychiatric illness
• History of gastrointestinal disorders
• Food allergies
• Pregnancy, breast feeding
• Body piercings that cannot be removed
• History of claustrophobia
• Left-hander

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1.56 g L-Tryptophan; 1.56 g L-Tryptophan in 300 mL tap water given via nasogastric tube + after 60 min: 500ml of a mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate) given via nasogastric tube	Dietary supplement: 1.56 g L-Tryptophan; Dietary supplement: Tap water; Dietary supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate); Device: Nasogastric Tube
Active Comparator: 1.56 g L-Leucine; 1.56 g L-Leucine in 300 mL tap water given via nasogastric tube + after 60 min: 500ml of a mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate) given via nasogastric tube	Dietary supplement: Tap water; Dietary supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate); Device: Nasogastric Tube; Dietary supplement: 1.56 g L-Leucine
Active Comparator: 50 g Xylitol; 50 g Xylitol in 300 mL tap water given via nasogastric tube	Dietary supplement: Tap water; Device: Nasogastric Tube; Dietary supplement: 50 g Xylitol
Active Comparator: 75 g Erythritol; 75 g Erythritol in 300 mL tap water given via nasogastric tube	Dietary supplement: Tap water; Device: Nasogastric Tube; Dietary supplement: 75 g Erythritol
Placebo Comparator: 75 g Glucose and mixed liquid meal; 75 g Glucose in 300 mL tap water given via nasogastric tube + after 60 min: 500ml of a mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate) given via nasogastric tube	Dietary supplement: Tap water; Dietary supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate); Device: Nasogastric Tube; Dietary supplement: 75 g Glucose
Placebo Comparator: Tap water and mixed liquid meal; 300 mL tap water given via nasogastric tube + after 60 min: 500ml of a mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate) given via nasogastric tube	Dietary supplement: Tap water; Dietary supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate); Device: Nasogastric Tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect of aminoacids on cerebral blood flow measured by functional brain MRI	changes from baseline to one hour after treatment
Effect of sugar alcohols on cerebral blood flow measured by functional brain MRI	changes from baseline to one hour after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Measurement of Plasma Glucose concentrations	changes from baseline to three hours after treatment
Measurement of Plasma Insulin concentrations	changes from baseline to three hours after treatment
Measurement of Plasma cholecystokinin concentrations	changes from baseline to three hours after treatment
Measurement of Plasma Glucagon-like Peptide (GLP-1) concentrations	changes from baseline to three hours after treatment
Measurement of Plasma PYY concentrations	changes from baseline to three hours after treatment
Measurement of Plasma ghrelin concentrations	changes from baseline to three hours after treatment

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Chair: Christoph Beglinger, Prof., University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 26, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vasodilator Agents; Psychotropic Drugs; Antidepressive Agents; Antidepressive Agents, Second-Generation; Erythritol; Tryptophan
• Other Study ID Numbers: fMRI Aminoacids

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No