Effects of intestinal Amarasate™ (a bitter hops extract) on gut function in healthy, lean volunteers.

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Healthy human gastrointestinal physiology; Obesity; Diet and Nutrition - Obesity; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12619000813189
• Lead Sponsor: Professor Christine Feinle-Bisset

Brief Summary

In healthy men, intraduodenal administration of Amarasate, at the dose of 250 mg, had modest, and transient effects to stimulate pyloric pressures during the first 90 min post-administration and a significant effect to stimulate PYY beyond 60 min post-administration, but, at both doses of 100 and 250 mg, had no effect on CCK, appetite perceptions and gastrointestinal symptoms or energy intake.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-04
• Study Completion: 2019-08-30
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

A total of 12 healthy, lean (BMI 19-25 kg/m2) male subjects, aged between 18 - 60 years will be included. Subjects will be required to be weight stable (ie <5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceding 4 weeks.

Exclusion Criteria

Significant GI symptoms, 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, cisapride, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
Lactose intolerance/other food allergy(ies), including hops allergy, diagnosed idiopathic anaphylaxis or occupational exposure to hops (hops pickers, brewers)
Current gallbladder or pancreatic disease
Cardiovascular or respiratory diseases
Individuals with low ferritin levels (females <15 ng/mL, males <30 ng/mL), or who have donated blood in the 12 weeks prior to taking part in the study
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 of cigarettes/cigars/marijuana
Recreational drug use
Current intake of any illicit substance
Vegetarians
Inability to tolerate nasogastric tube
Inability to comprehend study protocol
Restrained eaters (score >12 on the 3-factor eating questionnaire)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of gastrointestinal hormones, e.g. CCK, GLP-1, PYY and ghrelin, will be assessed by Enzyme-linked Immunosorbent Assay (ELISA) or Radio Immunosorbent Assay (RIA).<br><br>This intervention is of an exploratory nature to characterise the effects of varying doses of amarasate. As such, it is unknown which plasma concentrations of gastrointestinal hormones may prove to be of importance. Hence these have been grouped into one composite primary outcome. <br>[At t = -10 min, 10 minute intervals from t= 10- 30 min, 15 min intervals from t= 30 - 60 min, 30 min intervals from t= 60 - 180 min, and at t= 210 min.];Antropyloroduodenal pressures will be measured using a 17-channel manometric assembly (Dentsleeve, Mui Scientific). [Baseline (t = -10 - 0 min) and after intraduodenal administration (t = 0 - 180 min).]