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

NCT02563847 | Completed

• 1 other identifier: EKBB 2014/072
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endocrine System Diseases

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Effect of different aminoacids and sugar alcohols on gastric emptying

  changes from baseline to four hours after treatment

Study Arms (7)

0.52 g L-Tryptophan

ACTIVE COMPARATOR

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

1.56 g L-Tryptophan

ACTIVE COMPARATOR

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

1.56 g L-Leucine

ACTIVE COMPARATOR

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

50 g Xylitol

ACTIVE COMPARATOR

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

75 g Erythritol

ACTIVE COMPARATOR

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

75 g Glucose

PLACEBO COMPARATOR

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

Tap water

PLACEBO COMPARATOR

300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube

Dietary Supplement: 300 mL tap water; Other: 50 mg 13C-sodium acetate

Interventions

0.52 g L-Tryptophan DIETARY_SUPPLEMENT

0.52 g L-Tryptophan

1.56 g L-Tryptophan DIETARY_SUPPLEMENT

1.56 g L-Tryptophan

1.56 g L-Leucine DIETARY_SUPPLEMENT

1.56 g L-Leucine

50 g Xylitol DIETARY_SUPPLEMENT

50 g Xylitol

75 g Erythritol DIETARY_SUPPLEMENT

75 g Erythritol

75 g Glucose DIETARY_SUPPLEMENT

75 g Glucose

300 mL tap water DIETARY_SUPPLEMENT

Tap water

50 mg 13C-sodium acetate OTHER

0.52 g L-Tryptophan; 1.56 g L-Leucine; 1.56 g L-Tryptophan; 50 g Xylitol; 75 g Erythritol; 75 g Glucose; Tap water

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Phase 1 Research Unit

Basel, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 27875537 DERIVED

MeSH Terms

Conditions

Endocrine System Diseases

Interventions

Tryptophan; Leucine; Xylitol; Erythritol; Glucose

Intervention Hierarchy (Ancestors)

Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Amino Acids, Branched-Chain; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Hexoses; Monosaccharides; Sugars

Study Officials

• Christoph Beglinger, Prof.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

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: May 26, 2015
• First Posted: September 30, 2015
• Study Start: May 1, 2014
• Primary Completion: March 1, 2015
• Last Updated: September 30, 2015

Record last verified: 2015-09

Locations

CH (1)