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Completed

NCT Number: NCT01674946

Effect of Bile Acids on the Secretion of Satiation Peptides in Humans

The purpose of this study is do determine the functional significance of the G protein-coupled receptor TGR5 in the secretion of GI satiation peptides by using natural bile acids and oleanolic acid (triterpenoid compound of plant origin) as TGR5 agonists.

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Key information

Conditions

Echolocation Animal Communication Behavior Behavior, Animal

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Basel, Phase 1 Research Unit

Basel, 4031, Switzerland

About this study

TGR5 is expressed in GLP-1-secreting cell lines and L cells from mice; gain- and loss-of-function models suggest a physiological role for TGR5 activation on GLP-1 secretion in rodents. TGR5 signaling showed improved postprandial glucose tolerance in obese mice, associated with marked postprandial GLP-1 release and insulin secretion. In contrast, TGR5-/- mice exhibited reduced glucose tolerance. In animals, TGR5 activation has been shown for natural bile acids (BAs) and triterpenoid compounds of plant origin, such as oleanolic acid (OA), suggesting a role for postprandial BAs in modulating nutrient-induced GLP-1 secretion. We therefore hypothesized that intraduodenal (ID) perfusions of TGR5 agonists (BAs and OA) stimulate the secretion of GLP-1 with respective changes in the glucose metabolism of healthy humans.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subjects
  • BMI of 19.0-24.5
  • Age 18-40
  • Stable body weight for at least 3 months

Exclusion criteria

  • Smoking
  • Substance abuse
  • Regular intake of medication
  • Medical of psychiatric illness
  • Gastrointestinal disorders or food allergies

Treatment and study plan

Saline

Other

intraduodenal perfusion

bile acid (CDCA, chenodeoxycholic acid)

Other

intraduodenal perfusion

Other names: primary bile acid

oleanolic acid

Other

intraduodenal perfusion

Other names: triterpenoid compound of plant origin

Oleic acid

Dietary Supplement

intraduodenal perfusion

Other names: fatty acid

Primary outcomes

  1. Gastrointestinal satiation peptide secretion

    Time frame: 3 hours blood sampling

    Assessment of plasma GLP-1, PYY and CCK release to BA and OA stimulation

Secondary outcomes

  1. Serum bile acids

    Time frame: 3 hours blood sampling

    Assessment of serum bile acids levels to BA and OA stimulation

  2. Appetite perceptions during 3 hours using visual analogue scales

    Time frame: 3 hours

    Assessment of the following appetite perceptions markers: feelings of hunger, feelings of prospective food consumption, feelings of fullness and feelings of satiety using validated visual analogue scales

  3. Glucose and insulin secretion

    Time frame: 3 hours blood sampling

    Assessment of plasma glucose and insulin levels to BA and OA stimulation

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Effect of Intraduodenal Perfusion of Bile Acids on the Secretion of Gastrointestinal Satiation Peptides in Healthy Male Volunteers

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Aug 29, 2012
Registry last updated
Aug 29, 2012

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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