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

Endocrine System Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563847
• Other study ID #: EKBB 2014/072
• Status: Completed
• Phase: N/A
• First received: May 26, 2015
• Last updated: September 28, 2015
• Start date: May 2014

Study information

• Verified date: September 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endocrine System Diseases

Intervention

Dietary Supplement:
• 0.52 g L-Tryptophan

• 1.56 g L-Tryptophan

• 1.56 g L-Leucine

• 50 g Xylitol

• 75 g Erythritol

• 75 g Glucose

• 300 mL tap water

Other:
• 50 mg 13C-sodium acetate

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Phase 1 Research Unit	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of different aminoacids and sugar alcohols on secretion of satiation hormones	Plasma concentrations of glucose	changes from baseline to three hours after treatment	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Effect of different aminoacids and sugar alcohols on gastric emptying	measured by C13 breath test	changes from baseline to four hours after treatment	No