NCT02823249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

June 27, 2016

Last Update Submit

February 26, 2017

Conditions

Endocrine System Diseases

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (6)

1.56 g L-Tryptophan

ACTIVE COMPARATOR

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-TryptophanDietary Supplement: Tap waterDietary Supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate)Device: Nasogastric Tube

1.56 g L-Leucine

ACTIVE COMPARATOR

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: 1.56 g L-LeucineDietary Supplement: Tap waterDietary Supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate)Device: Nasogastric Tube

50 g Xylitol

ACTIVE COMPARATOR

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

Dietary Supplement: 50 g XylitolDietary Supplement: Tap waterDevice: Nasogastric Tube

75 g Erythritol

ACTIVE COMPARATOR

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

Dietary Supplement: 75 g ErythritolDietary Supplement: Tap waterDevice: Nasogastric Tube

75 g Glucose and mixed liquid meal

PLACEBO COMPARATOR

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: 75 g GlucoseDietary Supplement: Tap waterDietary Supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate)Device: Nasogastric Tube

Tap water and mixed liquid meal

PLACEBO COMPARATOR

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 waterDietary Supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate)Device: Nasogastric Tube

Interventions

1.56 g L-TryptophanDIETARY_SUPPLEMENT
1.56 g L-Tryptophan
1.56 g L-LeucineDIETARY_SUPPLEMENT
1.56 g L-Leucine
50 g XylitolDIETARY_SUPPLEMENT
50 g Xylitol
75 g ErythritolDIETARY_SUPPLEMENT
75 g Erythritol
75 g GlucoseDIETARY_SUPPLEMENT
75 g Glucose and mixed liquid meal
Tap waterDIETARY_SUPPLEMENT
1.56 g L-Leucine1.56 g L-Tryptophan50 g Xylitol75 g Erythritol75 g Glucose and mixed liquid mealTap water and mixed liquid meal
Nasogastric TubeDEVICE
1.56 g L-Leucine1.56 g L-Tryptophan50 g Xylitol75 g Erythritol75 g Glucose and mixed liquid mealTap water and mixed liquid meal
Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate)DIETARY_SUPPLEMENT
1.56 g L-Leucine1.56 g L-Tryptophan75 g Glucose and mixed liquid mealTap water and mixed liquid meal

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Endocrine System Diseases

Interventions

TryptophanLeucineXylitolErythritolGlucoseProteinsCD36 AntigensCarbohydratesEnteral Nutrition

Intervention Hierarchy (Ancestors)

Amino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialAmino Acids, Branched-ChainSugar AlcoholsAlcoholsOrganic ChemicalsHexosesMonosaccharidesSugarsPlatelet Membrane GlycoproteinsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesFatty Acid Transport ProteinsMembrane Transport ProteinsCarrier ProteinsMembrane ProteinsReceptors, Cell SurfaceReceptors, ImmunologicScavenger Receptors, Class BReceptors, ScavengerReceptors, LDLReceptors, LipoproteinFeeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Christoph Beglinger, Prof.

    University Hospital, Basel, Switzerland

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 27, 2016

First Posted

July 6, 2016

Study Start

May 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

CH(1)