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

Primary Purpose

Endocrine System Diseases

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
1.56 g L-Tryptophan
1.56 g L-Leucine
50 g Xylitol
75 g Erythritol
75 g Glucose
Tap water
Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate)
Nasogastric Tube
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endocrine System Diseases

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

1.56 g L-Tryptophan

1.56 g L-Leucine

50 g Xylitol

75 g Erythritol

75 g Glucose and mixed liquid meal

Tap water and mixed liquid meal

Arm Description

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

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

50 g Xylitol in 300 mL tap water given via nasogastric tube

75 g Erythritol in 300 mL tap water given via nasogastric tube

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

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

Outcomes

Primary Outcome Measures

Effect of aminoacids on cerebral blood flow measured by functional brain MRI
Effect of sugar alcohols on cerebral blood flow measured by functional brain MRI

Secondary Outcome Measures

Measurement of Plasma Glucose concentrations
Measurement of Plasma Insulin concentrations
Measurement of Plasma cholecystokinin concentrations
Measurement of Plasma Glucagon-like Peptide (GLP-1) concentrations
Measurement of Plasma PYY concentrations
Measurement of Plasma ghrelin concentrations

Full Information

First Posted
June 27, 2016
Last Updated
February 26, 2017
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02823249
Brief Title
Effect of Amino Acids and Sugar Alcohols on Satiation Peptides and Activation of Specific Brain Regions
Official Title
Effect of Amino Acids and Sugar Alcohols on Release of Satiation Peptides and Activation of Specific Brain Regions in Normal Weight and Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocrine System Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.56 g L-Tryptophan
Arm Type
Active Comparator
Arm Description
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
Arm Title
1.56 g L-Leucine
Arm Type
Active Comparator
Arm Description
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
Arm Title
50 g Xylitol
Arm Type
Active Comparator
Arm Description
50 g Xylitol in 300 mL tap water given via nasogastric tube
Arm Title
75 g Erythritol
Arm Type
Active Comparator
Arm Description
75 g Erythritol in 300 mL tap water given via nasogastric tube
Arm Title
75 g Glucose and mixed liquid meal
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Tap water and mixed liquid meal
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
1.56 g L-Tryptophan
Intervention Type
Dietary Supplement
Intervention Name(s)
1.56 g L-Leucine
Intervention Type
Dietary Supplement
Intervention Name(s)
50 g Xylitol
Intervention Type
Dietary Supplement
Intervention Name(s)
75 g Erythritol
Intervention Type
Dietary Supplement
Intervention Name(s)
75 g Glucose
Intervention Type
Dietary Supplement
Intervention Name(s)
Tap water
Intervention Type
Dietary Supplement
Intervention Name(s)
Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate)
Intervention Type
Device
Intervention Name(s)
Nasogastric Tube
Primary Outcome Measure Information:
Title
Effect of aminoacids on cerebral blood flow measured by functional brain MRI
Time Frame
changes from baseline to one hour after treatment
Title
Effect of sugar alcohols on cerebral blood flow measured by functional brain MRI
Time Frame
changes from baseline to one hour after treatment
Secondary Outcome Measure Information:
Title
Measurement of Plasma Glucose concentrations
Time Frame
changes from baseline to three hours after treatment
Title
Measurement of Plasma Insulin concentrations
Time Frame
changes from baseline to three hours after treatment
Title
Measurement of Plasma cholecystokinin concentrations
Time Frame
changes from baseline to three hours after treatment
Title
Measurement of Plasma Glucagon-like Peptide (GLP-1) concentrations
Time Frame
changes from baseline to three hours after treatment
Title
Measurement of Plasma PYY concentrations
Time Frame
changes from baseline to three hours after treatment
Title
Measurement of Plasma ghrelin concentrations
Time Frame
changes from baseline to three hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Beglinger, Prof.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Basel
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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