None listed
Conditions
Brief summary
This trial will observe the physiological gastrointestinal responses to a single dose (20 drops, 1.1 ml) of STW5-II, vs placebo, to investigate the mechanisms by which this herbal preparation may exert its gastrointestinal symptom relieving effects. Participants will attend two visits at which they will receive either STW5-II or placebo, and oesophago-gastric junction pressures will be measured for the following two hours. The hypothesis is that STW5-II will increase lower oesophageal sphincter pressure compared with placebo.
Interventions
This trial will observe the physiological gastrointestinal responses to a single dose (20 drops, 1.1 ml) of STW5-II to investigate the mechanisms by which this herbal preparation may exert its gastrointestinal symptom relieving effects.
Two study visits, separated by at least four days, are required. Visits will last approximately 3 hours each. Participants will receive, in randomised, double-blind fashion, oral administration of either (i) 20 drops (1.1ml) of STW5-II or (ii) 20 drops (1.1ml) c
This trial will observe the physiological gastrointestinal responses to a single dose (20 drops, 1.1 ml) of STW5-II to investigate the mechanisms by which this herbal preparation may exert its gastrointestinal symptom relieving effects. Two study visits, separated by at least four days, are required. Visits will last approximately 3 hours each. Participants will receive, in randomised, double-blind fashion, oral administration of either (i) 20 drops (1.1ml) of STW5-II or (ii) 20 drops (1.1ml) control solution (i.e. containing no active ingredients). For both study visits, participants will fast for ~14 hrs overnight, and abstain from alcohol and vigorous exercise for 24 hrs prior to each visit. On each study day, participants will attend the Gut Function Laboratories at the Department of Surgery, Flinders Medical Centre. Upon arrival, participants will be intubated with an 8 French (2.5mm diameter) solid-state unidirectional high-resolution manometry catheter (32 pressure sensors at 1cm, 16, 2 cm length impedance segments, Unisensor/Laborie, Attikon, Switzerland) which will be used to measure oesophago-gastric junction (OGJ) pressures. The catheter will be inserted through an anaesthetised nostril and passed until the pressure array straddles the OGJ region from distal oesophagus to stomach. Once correctly positioned and fixed in place, the sensor array straddling the OGJ, will not need further adjustment. After a 10-min period to accommodate to the presence of the catheter, baseline OGJ pressure will be recorded for a 10-min period (t = -15 to -5 min) during which time each participant will complete a VAS questionnaire to assess GI perceptions (fullness, nausea, bloating). These scales consist of a horizontal line, 100 mm long, on which the participant places a vertical mark across the line, indicating the strength of each symptom felt at that time, with 0 mm indicating that the symptom is not felt and 100 mm that the symptom is extremely strong. At t = -5 min, participants will ingest 50 ml of water with either (i) STW5-II or (ii) control solution (as stated previously), immediately followed by a mixed solid-liquid meal to be consumed within 5 min. The meal will consist of 100 g minced beef burger (270 kcal, 25 g protein, 21 g fat) and will be immediately followed by 150 ml of dextrose (10 %, 62 kcal). Complete ingestion of STW5-II or placebo, each with 50 mls water, and the meal, will be confirmed by the investigator. OGJ pressures will then be measured for 120 min, and participants will complete VAS questionnaires every 15 min. At t = 120 min, the manometric assembly will be removed. The participant will be offered a light refreshment after which they will be free to leave the laboratory.
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
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 - 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) - 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 tolerate oro/naso-gastric tube - 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)
Outcome results
None listed