The effects of the herbal preparation, STW5-II, on gastric emptying in healthy volunteers.

Not Applicable

• Conditions: Functional Dyspepsia; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12621000204842
• Lead Sponsor: niversity of Adelaide

Brief Summary

The study was stopped early due to recruitment difficulties. Statistical analysis was not performed on data obtained.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-26
• Study Completion: 2022-06-29
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Healthy, lean (BMI: 19-25 kg/m2) male and female volunteers will be included. Participants will be required to be weight-stable (ie <5% fluctuation) at study entry. Females will be required to be premenopausal and studied during the follicular phase of the menstrual cycle

Exclusion Criteria

Each participant will be questioned prior to the study to exclude:
- regular GI symptoms, as measured by the GI symptom score (score >1 for any component), or significant GI disease or surgery
- use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, GI function, body weight or appetite (eg domperidone, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
- regular medication that cannot be discontinued during the study where it may affect outcomes
- lactose intolerance/other food allergy, or allergy to any of the ingredients of STW5-II
- current gallbladder or pancreatic disease
- cardiovascular or respiratory diseases
- epilepsy
- any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above)
- Exposure to ionising radiation from X-ray machines or radioactive substances in the last 12 months for research purposes
- high performance athletes
- current intake of > 2 standard drinks on > 5 days per week
- current smokers/users of tobacco products (including pipe, chewing, cigarettes, cigars, sheesha, vaping)
- recreational drug use (e.g marijuana)
- current intake of any illicit substance
- vegetarians
- inability to comprehend study protocol
- in female participants, pregnancy, lactation or surgical sterilisation (a pregnancy test will be performed, using a urine sample, prior to each study day)

Study & Design

• Study Type: Interventional
• Study Design: Not specified