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Completed

NCT Number: NCT02563847

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

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.

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Key information

Conditions

Endocrine System Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel, Phase 1 Research Unit

Basel, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.52 g L-Tryptophan

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

300 mL tap water

Dietary Supplement

50 mg 13C-sodium acetate

Other

Primary outcomes

  1. Effect of different aminoacids and sugar alcohols on secretion of satiation hormones

    Time frame: changes from baseline to three hours after treatment

    Plasma concentrations of glucose

  2. Effect of different aminoacids and sugar alcohols on secretion of satiation hormones

    Time frame: changes from baseline to three hours after treatment

    Plasma concentrations of insulin are measured

  3. Effect of different aminoacids and sugar alcohols on secretion of satiation hormones

    Time frame: changes from baseline to three hours after treatment

    Plasma concentrations of glucagon are measured

  4. Effect of different aminoacids and sugar alcohols on secretion of satiation hormones

    Time frame: changes from baseline to three hours after treatment

    Plasma concentrations of glucagon-like Peptide (GLP-1) are measured

  5. Effect of different aminoacids and sugar alcohols on secretion of satiation hormones

    Time frame: changes from baseline to three hours after treatment

    Plasma concentrations of PYY are measured

  6. Effect of different aminoacids and sugar alcohols on secretion of satiation hormones

    Time frame: changes from baseline to three hours after treatment

    Plasma concentrations of cholecystokinin are measured

Secondary outcomes

  1. Effect of different aminoacids and sugar alcohols on gastric emptying

    Time frame: changes from baseline to four hours after treatment

    measured by C13 breath test

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
First posted
Sep 30, 2015
Registry last updated
Sep 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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