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 gastric emptying will be measured for the following three hours. The hypothesis is that STW5-II will increase meal retention in the proximal stomach and decrease content in the antrum, without affecting overall gastric emptying.
Interventions
This trial will observe the physiological gastrointestinal responses to a single dose (20 drops, 1.1 ml) of STW5-II, compared with placebo, 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, each lasting approximately 3 hours. Participants will receive, in randomised, double-blind fashion, oral administration of either (i) 20 drops (1.1ml) of STW5-II or (ii) 20 d
This trial will observe the physiological gastrointestinal responses to a single dose (20 drops, 1.1 ml) of STW5-II, compared with placebo, 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, each lasting approximately 3 hours. 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 Gamma Camera Suite at the Clinical Research Facility, Adelaide Medical School, Adelaide Health and Medical Sciences (AHMS) Building at 8:30am. Upon arrival, the participant will rest quietly, seated with their back against a gamma camera. The participant will then be asked to complete a visual analogue scale (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. Further VAS questionnaires will be administered at 15-min intervals throughout the study. The participant will then ingest 50 ml of water with either (i) STW5-II or (ii) control solution (as stated previously), immediately followed by a solid-liquid meal to be consumed within 5 min. Complete ingestion of STW5-II or placebo, each with 50 mls water, will be confirmed by the investigator. The meal will consist of 100 g minced beef burger (270 kcal, 25 g protein, 21 g fat) radiolabelled with 20 MBq 99mTc-sulphur colloid and will be immediately followed by 150 ml of dextrose (10 %, 62 kcal) radiolabelled with 7 MBq 67Ga-EDTA. Gastric emptying and intragastric meal distribution of the solid and liquid components of this meal will be measured from t = 0-120 min, where t = 0 min represents the time of meal completion. On one of the study days (decided by the investigator), following the 120 min intervention, participants will drink 100 ml water containing 4 MBq of 99mTc-sulphur colloid, and a lateral image of the stomach will be acquired to derive correction factors for gamma ray attenuation. This will take < 5 min. At the end of the study day, the participant will be offered a light lunch and then 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
40 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 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)
Outcome results
None listed