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Effects of Diet on Reflux and Dyspepsia

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ClinicalTrials.gov Identifier: NCT02425553
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

Reflux and dyspeptic symptoms are common affecting 10-20% of the population on a regular basis. Reflux symptoms such as heartburn and regurgitation are caused by the return of acid or non-acid gastric contents into the esophagus. Dyspeptic symptoms are caused by abnormal gastric relaxation (impaired accommodation) or increased sensitivity of the stomach to distension during the meal.

The effects of diet on gastrointestinal function are debated and the efficacy of dietary management for digestive symptoms has not been established. Epidemiological studies suggest an effect; however, it is not possible to distinguish the effects of fat intake and total energy (i.e. calorie) intake in this work. This issue has been addressed by small physiological studies. The results show that esophageal acid exposure was related to total calorie intake but not to fat content. In contrast, the number of reflux symptoms was 40% higher after the high-fat than the low-fat meals. Similar findings were found for the relationship between gastric distension, fullness and dyspeptic symptoms by Magnetic Resonance Imaging. Thus, it appears that fat does not cause digestive dysmotility but heightens sensitivity to visceral events and so increases the number and severity of symptoms reported by patients. As yet, these findings have not been confirmed in larger, more representative surveys.

Similar to the effects of food, there are inconsistent findings regarding the effects of alcohol on gastro-esophageal reflux (GER) and gastric function. Physiological studies have noted delayed gastric emptying and an increase in reflux events when alcohol is taken with food. However, larger surveys have not confirmed that alcohol triggers reflux or dyspeptic symptoms.

The proposed observational, dietary study with cross-over design will assess the independent effects of energy intake (i.e. calorie load) and fat intake on gastric fullness, the number and severity of reflux and dyspeptic symptoms after meals. The effect of alcohol on symptoms after the high calorie, high fat meals will also be documented. The study population of senior academics attending a conference are likely to have a relatively high prevalence of risk factors for gastro-esophageal reflux disease (GERD) being predominantly male, with an older age and a larger waist circumference than average in the general community. This will increase study power and relevance of the findings.

The results will provide new information concerning the impact of dietary factors and alcohol on digestive symptoms after meals. This data will inform future guidelines for the dietary management of patients with reflux and dyspeptic symptoms after meals which will be relevant in both primary and secondary care.


Condition or disease Intervention/treatment
Gastroesophageal Reflux Dyspepsia Other: Diet

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Effects of Diet and Alcohol on Fullness, Reflux and Dyspeptic Symptoms After Meals
Study Start Date : April 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Indigestion

Group/Cohort Intervention/treatment
Faculty and Delegates of Ascona II Meeting Other: Diet
High calorie (1200 kcal), high fat (50% energy), 400 ml juice (230 kcal)
Other Name: Dinner

Other: Diet
High calorie (1200 kcal), low fat (20% energy), 400 ml juice (230 kcal)
Other Name: Dinner

Other: Diet
Low calorie (600 kcal), low fat (20% energy), 400 ml juice (230 kcal)
Other Name: Dinner

Other: Diet
High calorie (1200 kcal), high fat (50% energy), 300 ml wine (40 g alcohol, 230 kcal), 100 ml water
Other Name: Dinner




Primary Outcome Measures :
  1. Number of reflux symptoms [ Time Frame: Participants will be followed for the duration of the conference, an expected average of 4 days ]
    Similar to "Pharmacokinetic outcome measures" the occurrence of reflux symptoms after each dinner will be summed up and compared between different dinners.

  2. Number of dyspeptic symptoms [ Time Frame: Participants will be followed for the duration of the conference, an expected average of 4 days ]
    Similar to "Pharmacokinetic outcome measures" the occurrence of dyspeptic symptoms after each dinner will be summed up and compared between different dinners.


Secondary Outcome Measures :
  1. The severity of reflux symptoms measured by a visual-to-analogue scale from 0 to 100 [ Time Frame: Participants will be followed at time points -30 min (before dinner) and at 0, 30, 60, 90, 120, 150, 180 min (after dinner) for 4 consecutive days ]
  2. The severity of dyspeptic symptoms measured by a visual-to-analogue scale from 0 to 100 [ Time Frame: Participants will be followed at time points -30 min (before dinner) and at 0, 30, 60, 90, 120, 150, 180 min (after dinner) for 4 consecutive days ]
  3. The sensation of fullness measured by a visual-to-analogue scale from 0 to 100 [ Time Frame: Participants will be followed at time points -30 min (before dinner) and at 0, 30, 60, 90, 120, 150, 180 min (after dinner) for 4 consecutive days ]

Other Outcome Measures:
  1. Quality of Life measured by EQ-5D Quality of Life questionnaire [ Time Frame: Participants will be followed for the duration of the conference, an expected average of 4 days ]
    A 5-item index score, the VAS score and the utility score (composite score calculated from the first two scores) from the EQ-5D Quality of Life questionnaire.

  2. Postprandial Distress measured by Leuven dyspepsia questionnaire [ Time Frame: Participants will be followed for the duration of the conference, an expected average of 4 days ]
    A composite score from Leuven dyspepsia questionnaire will be analysed

  3. Safety outcome measured by the number of severe reflux symptoms [ Time Frame: Participants will be followed for the duration of the conference, an expected average of 4 days ]
    Severe reflux symptom was defined as >60% on the visual-to-analogue scale form 0 to 100

  4. Safety outcome measured by the number of severe dyspeptic symptoms [ Time Frame: Participants will be followed for the duration of the conference, an expected average of 4 days ]
    Severe dyspeptic symptom was defined as >60% on the visual-to-analogue scale form 0 to 100



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be all faculty and delegates attending the "Ascona II: Advances in clinical measurement of gastrointestinal motility and function" conference that agree to participate in the study and sign the informed consent form.
Criteria

Inclusion Criteria:

  • Participants will be faculty and delegates attending the "Ascona II: Advances in clinical measurement of gastrointestinal motility and function" conference.

Exclusion Criteria:

  • Age < 18,
  • special dietary requirements incompatible with meals served at congress hotel restaurant,
  • participation in another study with investigational drug within the 30 days preceding and during the present study (purely diagnostic studies are acceptable),
  • individuals unwilling to provide written informed consent,
  • inability to follow the procedures of the study, e.g. due to language problems (all study documents in English).

Participants with a history of alcohol dependency or medical conditions that may be exacerbated or affected by alcohol intake are allowed to participate but are instructed not to drink the alcohol provided with the high calorie, high fat test meal on day 4.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425553


Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Mark R Fox, Prof. (UK) Division of Gastroenterology and Hepatology, University Hospital Zurich, Switzerland

Publications:
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02425553     History of Changes
Other Study ID Numbers: KEK-Nr. 2015-0095
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: June 2015

Keywords provided by University of Zurich:
Diet
Reflux
Dyspepsia
Symptoms
Alcohol

Additional relevant MeSH terms:
Gastroesophageal Reflux
Dyspepsia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms