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Description: This study was undertaken to understand more about functional dyspepsia, a common condition of recurring symptoms of indigestion that have no obvious cause but can have a profound adverse effect on quality of life. Honey has been used since ancient times to treat or prevent indigestion symptoms. Studies show that mānuka honey has unique natural compounds that could reduce inflammation in the upper gastrointestinal tract. This inflammation is associated with the symptoms of functional dyspepsia and reducing inflammation might improve indigestion symptoms.
Comvita Ltd is a New Zealand owned mānuka honey manufacturer. They have recently identified a unique natural compound in mānuka honey, called Lepteridine™, which has also been shown to have anti-inflammatory properties. There have been no clinical trials investigating the effects of manuka honey or Lepteridine™ on functional dyspepsia symptoms.
In this study we will compare the effects of consuming mānuka honey containing different amounts of Lepteridine™, over six weeks, on functional dyspepsia symptoms, inflammation, and quality of life. This study will also help us to design future studies on the effects of consuming mānuka honey on symptoms of functional dyspepsia to gain a fuller understanding of the benefits of mānuka honey on this condition.
Publisher
University of AucklandTemporal coverage: start
2021-01-01HVN Project / Programme Name
HVN1953 SOOTHEData access requirements
Individual participant data is not available to the public. A copy of the informed consent form will be available on request (soothestudy@otago.ac.nz).Principal investigator organisation
University of OtagoCollaborating researchers and affiliations
Principal Investigator:
-Dr Jody Miller, Department of Human Nutrition, University of Otago, Dunedin
-Professor Nicole Roy, Department of Human Nutrition, University of Otago, Dunedin
Associate Investigators:
-Professor Richard Gearry (University of Otago)
-Professor Michael Schultz (University of Otago)Data description
Outcomes of the Study and associated data
Primary outcomes
- Symptom severity and quality of life indices specific to functional dyspepsia (Nepean Dyspepsia Index score)
- Feasibility determined by a composite of the number of participants recruited and attrition rates.
Associated data: Nepean Dyspepsia Index score, feasibility score
Secondary outcomes
- Composite gastrointestinal symptoms score using the Patient-Reported Outcomes Measurement Information System Questionnaire (PROMIS Gastrointestinal)
- Anxiety scores using the Patient-Reported Outcomes Measurement Information System Questionnaire (PROMIS Anxiety)
- Dyspepsia-related quality of life (Nepean Dyspepsia Index)
- Epigastric pain score (Nepean Dyspepsia Index)
- Postprandial discomfort score (Nepean Dyspepsia Index)
- Stool form and frequency via daily bowel habit diary
- Spontaneous symptom resolution (Nepean Dyspepsia Index score)
- Faecal metabolome, metagenome, metagenome assemblies, bile and organic acid production
- Composite cardiovascular risk profile
- Plasma matrix metallopeptidase-9
- Blood immune markers
- Blood inflammation markers
- Postprandial appearance of manuka honey-derived compounds and metabolites
Associated data: PROMIS Gastrointestinal, PROMIS Anxiety, dyspepsia-related quality of life, epigastric pain score, postprandial discomfort score, stool form and frequency, spontaneous symptom resolution, faecal metabolome/metagenome/metagenome assemblies, cardiovascular risk profile, plasma matric metallopeptidase-9, immune markers, inflammation markers, postprandial appearance of manuka honey-derived compounds and metabolitesPrincipal investigator contact email
jody.miller@otago.ac.nz
