None listed
Conditions
Brief summary
We are undertaking this study 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. Symptoms of functional dyspepsia include: o Pain or burning in the stomach, bloating, excessive belching, or nausea after meals o An early feeling of fullness when eating o Pain in the stomach that may sometimes occur unrelated to meals or may be relieved with meals At present, treatment options to relieve symptoms of functional dyspepsia are limited, often have only a modest effect and tend not to provide long-term improvement. Honey has been used since ancient times to treat or prevent indigestion symptoms. Studies show that manuka 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 manuka honey manufacturer. They have recently identified a unique natural compound in manuka 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 manuka 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 manuka honey on symptoms of functional dyspepsia to gain a fuller understanding of the benefits of manuka honey on this condition.
Interventions
The intervention consists of two manuka honey products containing either A) 0.1 mg or B) 0.4 mg of Lepteridine™ per 10 g of honey. Lepteridine™ is a natural compound unique to manuka honey. The levels of Lepteridine™ in the two honey products are the high and low levels found naturally in manuka honey.
The study duration is a nominal total of ten weeks, with a two-week lead-in phase, six week intervention phase, and follow-up two weeks after the end of the intervention.
The 2-weeks lead-in pha
The intervention consists of two manuka honey products containing either A) 0.1 mg or B) 0.4 mg of Lepteridine™ per 10 g of honey. Lepteridine™ is a natural compound unique to manuka honey. The levels of Lepteridine™ in the two honey products are the high and low levels found naturally in manuka honey. The study duration is a nominal total of ten weeks, with a two-week lead-in phase, six week intervention phase, and follow-up two weeks after the end of the intervention. The 2-weeks lead-in phase requires participants to record their bowel motion every day on an app designed for this trial, and complete a weekly questionnaire about their digestive health and general wellbeing (to be completed for the full ten weeks); and complete a non-consecutive 3-day food diary on the 2nd week of lead-in phase. Participants will provide a faecal sample and fast overnight for 9 hours one day prior to their baseline visit (end of 2nd week of lead-in phase). At their baseline visit (beginning of intervention phase) participants will provide a fasted blood sample, have height and weight measured, complete a set of questionnaires in regards to their mental and physical health, general well-being, and clinical variables. A subgroup of participants will provide blood samples before consuming 10 g of their honey product at the clinic, and then provide blood samples 1, 2, 3, and 5 hours after consumption. The first 5 participants in each group who consent to providing these samples will participate in the substudy. During the six week intervention phase, participants will consume 10 g of their assigned honey product twice per day, before morning and dinner, complete their daily bowel motion app and weekly digestive health questionnaires, for six weeks. The honey will be packaged in sachets containing one serving size. Participants will be given two-weeks supply of honey to take home. Compliance will be monitored by checklist and measuring returned unused sachets. Participants will attend the study clinic at weeks 2 and 4 to return unused sachets, pick up their next two weeks of honey, and give a fasted blood sample. At the final clinic visit (end of intervention phase), the aforementioned baseline visit procedures will be repeated, except the sub study blood samples which will not be repeated. Prior to the final visit, participants will again complete the same set of questionnaires and non-consecutive 3-day food diary, provide a faecal sample, and fast overnight for 9 hours. During the clinic visit, they will provide a fasted blood sample and have their weight measured. Participants will receive their reimbursement (grocery vouchers). Attendance of clinic visits and completion of questionnaires will be assessed to measure the adherence of participants. Two-weeks after the final clinic visit, participants will complete an online survey regarding their mental and physical health, general wellbeing, and gastrointestinal symptoms; the link to this survey will be sent to the participant by email.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Adults with mild/moderate functional dyspepsia (FD) and Body Mass Index between 18.5 and 35 kg/m2. FD participants will be selected based on the ROME IV Diagnostic Criteria (fulfilled for the last three months with symptom onset at least six months prior to diagnosis): 1. Must include one or more of the following: - Bothersome postprandial fullness - Bothersome early satiation - Bothersome epigastric pain severe enough to impact on usual activities - Bothersome epigastric burning severe sufficient to impact on normal activities AND 2. No previous diagnosis of structural disease (including at upper endoscopy) that is likely to explain the symptoms AND 3. Must fulfil criteria for Postprandial Distress Syndrome (PDS) and/or Epigastric Pain Syndrome (EPS) as follows: a. PDS: must include one or both of the following at least three days a week: - Bothersome postprandial fullness severe enough to impact on usual activities - Bothersome early satiation severe enough sufficient to prevent finishing a regular size meal b. EPS: must include one or both of the following at least one day a week: - Bothersome epigastric pain severe enough to impact on usual activities - Bothersome epigastric burning severe sufficient to impact on usual activities People with mild to moderate severity of dyspepsia will be identified with the Short Form Leeds Dyspepsia Questionnaire. This consists of eight items that assess the presence and severity of dyspepsia by measuring the frequency and severity of upper abdominal pain/discomfort, heartburn, regurgitation and nausea. Possible scores range from 0 to 32 with higher values corresponding with increasing severity of dyspepsia. A score of 1 to 23 indicates mild to moderate dyspepsia symptoms.
Exclusion criteria
- Inability to give informed consent - Severe functional dyspepsia, defined by a score of 23 or higher from the Short Form Leeds Dyspepsia Questionnaire - Taken antibiotics within the month before starting the study - Use of certain prescribed medication or recreational drugs. People taking Proton Pump Inhibitors, H2-receptor antagonists, antacids, mucosal protectants, prokinetics, antidepressant drugs if they were prescribed solely for controlling dyspepsia symptoms, anticholinergic agents, cholinergic agents, and over-the-counter herbal remedies used to treat dyspepsia symptoms will be required to stop taking four weeks prior to the start of the study - Helicobacter pylori-positive (physician-diagnosed) or undertaking treatment for H. pylori infection within one month of initiation of study. Potential participants will also be screened for H. pylori infection prior to beginning the lead-in and intervention. - Alarm features associated with significant GI or other disorders, such as abdominal pain that wakes the patient from sleep; frequent vomiting; family history of gastrointestinal (GI) malignancies suggestive of a significant hereditary cancer syndrome; lower GI bleeding; odynophagia; dysphagia. - Medical history of upper GI surgery or other significant disorders (inflammatory bowel disease, ulcerative colitis, coeliac disease, Crohn's disease), significant cardiorespiratory disease, diabetes mellitus, significant bleeding disorders, sleep disorders, active psychiatric conditions (major depressive disorder, schizophrenia) - Significant weight loss (>5% of total body weight) during the six months before starting the study - Significant dietary changes within the month before starting the study (i.e., being on a controlled diet or dietary weight loss regimen) - Intolerance or allergy to honey and bee products - Pregnancy or breastfeeding - Smokers - Excessive alcohol intake >20 g of pure alcohol (2 drinks)/d on average (>21 standard drinks a week)
Outcome results
None listed