Effect of Amino Acids and Sugar Alcohols on Gastric Emptying and Release of Satiation Peptides in Humans

Effect of Amino Acids and Sugar Alcohols on Gastric Emptying and Release of Satiation Peptides in Normal Weight and Obese Subjects

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

Study Overview

• Status: Completed
• Conditions: Endocrine System Diseases
• Intervention / Treatment: Dietary supplement: 1.56 g L-Tryptophan; Dietary supplement: 1.56 g L-Leucine; Dietary supplement: 50 g Xylitol; Dietary supplement: 75 g Erythritol; Dietary supplement: 75 g Glucose; Dietary supplement: 0.52 g L-Tryptophan; Other: 50 mg 13C-sodium acetate; Dietary supplement: 300 mL tap water

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

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland
    • University Hospital Basel, Phase 1 Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.52 g L-Tryptophan; 0.52 g L-Tryptophan in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube	Dietary supplement: 0.52 g L-Tryptophan; Other: 50 mg 13C-sodium acetate
Active Comparator: 1.56 g L-Tryptophan; 1.56 g L-Tryptophan in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube	Dietary supplement: 1.56 g L-Tryptophan; Other: 50 mg 13C-sodium acetate
Active Comparator: 1.56 g L-Leucine; 1.56 g L-Leucine in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube	Dietary supplement: 1.56 g L-Leucine; Other: 50 mg 13C-sodium acetate
Active Comparator: 50 g Xylitol; 50 g Xylitol in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube	Dietary supplement: 50 g Xylitol; Other: 50 mg 13C-sodium acetate
Active Comparator: 75 g Erythritol; 75 g Erythritol in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube	Dietary supplement: 75 g Erythritol; Other: 50 mg 13C-sodium acetate
Placebo Comparator: 75 g Glucose; 75 g Glucose in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube	Dietary supplement: 75 g Glucose; Other: 50 mg 13C-sodium acetate
Placebo Comparator: Tap water; 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube	Other: 50 mg 13C-sodium acetate; Dietary supplement: 300 mL tap water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones	Plasma concentrations of glucose	changes from baseline to three hours after treatment
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones	Plasma concentrations of insulin are measured	changes from baseline to three hours after treatment
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones	Plasma concentrations of glucagon are measured	changes from baseline to three hours after treatment
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones	Plasma concentrations of glucagon-like Peptide (GLP-1) are measured	changes from baseline to three hours after treatment
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones	Plasma concentrations of PYY are measured	changes from baseline to three hours after treatment
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones	Plasma concentrations of cholecystokinin are measured	changes from baseline to three hours after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of different aminoacids and sugar alcohols on gastric emptying	measured by C13 breath test	changes from baseline to four hours after treatment

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• Meyer-Gerspach AC, Hafliger S, Meili J, Doody A, Rehfeld JF, Drewe J, Beglinger C, Wolnerhanssen B. Effect of L-Tryptophan and L-Leucine on Gut Hormone Secretion, Appetite Feelings and Gastric Emptying Rates in Lean and Non-Diabetic Obese Participants: A Randomized, Double-Blind, Parallel-Group Trial. PLoS One. 2016 Nov 22;11(11):e0166758. doi: 10.1371/journal.pone.0166758. eCollection 2016.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: September 28, 2015
• First Posted (Estimate): September 30, 2015

Study Record Updates

• Last Update Posted (Estimate): September 30, 2015
• Last Update Submitted That Met QC Criteria: September 28, 2015
• Last Verified: September 1, 2015

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: EKBB 2014/072