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Effect of Gingest on Symptoms of Dyspepsia

Primary Purpose

Dyspepsia, Epigastric Fullness, Bloating

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Gingest powdered extract obtained from Ginger rhizomes
Placebo
Sponsored by
Atlantia Food Clinical Trials
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy free-living men and women,
  2. Be aged 30 to 55 years (inclusive),
  3. Be willing to provide informed consent,
  4. Subject has upper abdominal pain or discomfort that is an unpleasant sensation, characterized by one or more of the following symptoms: early satiety, postprandial fullness, bloating, and nausea for at least 3 months during last year, without an identifiable underlying structural or biochemical motivation.
  5. Leeds Dyspepsia Questionnaire score 8 to 24 (mild-moderate)
  6. Beck's Depression Inventory score between 4 and 15

Exclusion Criteria:

  1. Pregnancy/lactation
  2. Subjects with relevant gastroesophageal reflux symptoms (retrosternal pain, burning, or regurgitation.
  3. Subjects with clear evidence of irritable bowel syndrome.
  4. Subjects under treatment with pharmacological substances that could influence the gastrointestinal system, such as prokinetics, ursodeoxycholic acid (UDCA), nonsteroidal anti-inflammatory drugs (NSAIDs), cholagogues, protonpump inhibitors, and H2 blockers, were asked to interrupt this treatment for one month before starting the study treatment.
  5. Subjects with previous diagnosis of cancer or with previous surgery of the upper gastro gastrointestinal endoscopy were performed in order to exclude the presence of structural or biochemical causes of dyspepsia.
  6. Participants are asked to avoid all foods containing ginger within the 14 days prior to study product administration and throughout the study. A list of foods high in ginger will be provided to subjects as a guide and this list will be reviewed at each visit.
  7. Subject with known allergy to components of the test product
  8. Any medical condition deemed exclusionary by the Principal Investigator
  9. Subject has a history of drug and / or alcohol abuse at the time of enrolment
  10. Change of dietary habit within the preceding month
  11. Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease
  12. Subject currently involved in any other clinical trial or having participated in a trial within the preceding 60 days,
  13. Subject has any concurrent medical or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements,
  14. Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation/severe, difficulty swallowing)
  15. Subject has a history of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years,
  16. Subject has a significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude supplement ingestion and/or assessment of safety and the study objectives,

Sites / Locations

  • Atlantia CRO, Heron House

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Gingest High

Gingest low

Placebo

Arm Description

200 mg/d Gingest (powdered extract obtained from Ginger rhizomes) for 4-weeks

100 mg/d Gingest (powdered extract obtained from Ginger rhizomes) + 100 mg maltodextrin for 4-weeks

200 mg/d maltodextrin for 4-weeks

Outcomes

Primary Outcome Measures

Intensity of functional dyspepsia symptom score over 4-weeks as measured by subject rating score at week-4
Overall score indicates the intensity of functional dyspepsia as defined by Subject's rating after four weeks of intervention with Gingest (100mg and 200mgs) versus placebo. The lower the score, the higher the intensity of the dyspeptic symptoms. 0: Not improved or worsened Slightly improved Markedly improved Completely improved

Secondary Outcome Measures

Intensity of functional dyspepsia symptoms over 2-weeks as measured by subject rating score
Overall score indicates the intensity of functional dyspepsia as defined by Subject's rating after two weeks of intervention with Gingest (100mg and 200mgs) versus placebo. 0: Not improved or worsened Slightly improved Markedly improved Completely improved
Severity of dyspeptic symptoms as measured by subject severity score measured at week-4.
Overall severity of specific suite of dyspeptic symptoms (including epigastric fullness, bloating, early satiety, nausea, vomiting epigastric pain) Absence of symptoms =0 Mild Symptoms = 1 Moderate Symptoms = 2 Severe symptoms = 3
Participant Global Assessment as measured by Participant Global Assessment Score at week-4
Participant Global Assessment Short Form 36 assesses the overall general mental and physical health. Answers are combined to produce the following. Physical function score= a higher score means better health Role limitation due to physical health Score: a lower score means better health Role limitations due to emotional problems Score: a lower score means better health Energy/ fatigue Score: a lower score means better health Emotional well-being Score: a higher score means better health Social Functioning Score: a higher score means better health Pain Score: a lower score means better health General health Score: a higher score means better health
Leeds Dyspepsia Questionnaire as measured by total score at week-4
Overall score is calculated from subject rating for frequency and severity responses for each symptom of dyspepsia. a summed total score of the frequency and severity responses for each symptom( Indigestion, heartburn, regurgitation, nausea combined) range: 0-32). 0= least severe.32= most severe each symptom = indigestion, regurgitation, heartburn and nausea a summed score of the frequency responses for each symptom (range: 0-16); a summed score of the severity responses for each symptom (range: 0-16); a categorized score of the single most frequent symptom (range: 0-4) and a categorized score of the single most severe symptom (range: 0-4).
Profile of Mood States Questionnaire (POMS) as measured by score at week-4.
Overall score assess changes in mood Not at all= 0 little = 1 Moderately = 2 Quite a lot = 3 Extremely = 4 Answers are combined. Higher the score for negative feelings i.e. tense the worse the mood. Higher the score for positive feelings i.e. Energetic the better the mood.
Beck's Depression Inventory as measured by score at week-4.
Overall score indicates severity of depressive symptoms 1-10 = These ups and downs are considered normal 11-16__ Mild mood disturbance 17-20__Borderline clinical depression 21-30_Moderate depression 31-40_Severe depression over 40__________________Extreme depression
Cortisol awakening response (nmol/L) at week-4.
Measures salivary cortisol (nmol/L)
Reduction in medication to manage number of episodes requiring medication for dyspeptic symptoms as measured at week-4
Number of times medication is taken to manage dyspeptic symptoms
Safety as assessed by adverse events and serious adverse events ongoing throughout the trial
Number of adverse events and serious adverse events

Full Information

First Posted
April 11, 2018
Last Updated
January 9, 2019
Sponsor
Atlantia Food Clinical Trials
Collaborators
Naturex SA
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1. Study Identification

Unique Protocol Identification Number
NCT03548363
Brief Title
Effect of Gingest on Symptoms of Dyspepsia
Official Title
A Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy of Gingest on Symptoms of Dyspepsia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 13, 2018 (Actual)
Primary Completion Date
January 2, 2019 (Actual)
Study Completion Date
January 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atlantia Food Clinical Trials
Collaborators
Naturex SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomised, double-blind, placebo controlled study on the effect of Gingest (ginger root extract) on symptoms of dyspepsia in 150 participants with mild to moderate dyspepsia.
Detailed Description
Functional dyspepsia (FD) is a chronic disorder of sensation and movement (peristalsis) in the upper digestive tract. A diagnosis of functional dyspepsia is determined when there is no evidence of structural disease and there have been at least three months of one or more of the following (with onset at least six months earlier). Ginger (Zingiber officinale) is traditionally used to treat a number of medical conditions, including those affecting the digestive tract, such as dyspepsia, flatulence, nausea and abdominal pain. Recent human clinical studies have found beneficial effects of ginger extract in patients with dyspepsia and gastric emptying in healthy populations. The aim of the present study is therefore to investigate if two different doses of Gingest (100mg and 200 mg) reduces intensity of functional dyspepsia (based on a symptom severity questionnaire) compared to placebo (maltodextrin) in 150 subjects with mild to moderate dyspepsia (as determined through the Leeds Dyspepsia Questionnaire).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Epigastric Fullness, Bloating, Epigastric Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, placebo-controlled, 4-week parallel intervention in subjects with mild to moderate Dyspepsia (as defined by the Leeds Dyspepsia Questionnaire) in 3-treatment arms: 1.) 100 mg/d Gingest; 2.) 200 mg/d Gingest; 3.) Placebo (maltodextrin)
Masking
ParticipantInvestigator
Masking Description
Both the investigators with any involvement in the study or data analysis prior to database locking and subjects are blinded to what treatment they receive.
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gingest High
Arm Type
Active Comparator
Arm Description
200 mg/d Gingest (powdered extract obtained from Ginger rhizomes) for 4-weeks
Arm Title
Gingest low
Arm Type
Active Comparator
Arm Description
100 mg/d Gingest (powdered extract obtained from Ginger rhizomes) + 100 mg maltodextrin for 4-weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
200 mg/d maltodextrin for 4-weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Gingest powdered extract obtained from Ginger rhizomes
Intervention Description
Description: Powdered extract obtained from Ginger rhizomes. Botanical name: Zingiber officinale Roscoe Plant part used: Dried rhyzome Extraction solvent: CO2 Extract Ratio 45-60 / 1 100mg of extract are equivalent to an average of 4400 mg of dry ginger rhizomes Composition: Natural extract, Calcium Hydroxide, Polysorbate 80, De-oiled soya lecithin, Calcium silicate
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
200 mg/d maltodextrin
Primary Outcome Measure Information:
Title
Intensity of functional dyspepsia symptom score over 4-weeks as measured by subject rating score at week-4
Description
Overall score indicates the intensity of functional dyspepsia as defined by Subject's rating after four weeks of intervention with Gingest (100mg and 200mgs) versus placebo. The lower the score, the higher the intensity of the dyspeptic symptoms. 0: Not improved or worsened Slightly improved Markedly improved Completely improved
Time Frame
4-weeks
Secondary Outcome Measure Information:
Title
Intensity of functional dyspepsia symptoms over 2-weeks as measured by subject rating score
Description
Overall score indicates the intensity of functional dyspepsia as defined by Subject's rating after two weeks of intervention with Gingest (100mg and 200mgs) versus placebo. 0: Not improved or worsened Slightly improved Markedly improved Completely improved
Time Frame
2-weeks
Title
Severity of dyspeptic symptoms as measured by subject severity score measured at week-4.
Description
Overall severity of specific suite of dyspeptic symptoms (including epigastric fullness, bloating, early satiety, nausea, vomiting epigastric pain) Absence of symptoms =0 Mild Symptoms = 1 Moderate Symptoms = 2 Severe symptoms = 3
Time Frame
4-weeks
Title
Participant Global Assessment as measured by Participant Global Assessment Score at week-4
Description
Participant Global Assessment Short Form 36 assesses the overall general mental and physical health. Answers are combined to produce the following. Physical function score= a higher score means better health Role limitation due to physical health Score: a lower score means better health Role limitations due to emotional problems Score: a lower score means better health Energy/ fatigue Score: a lower score means better health Emotional well-being Score: a higher score means better health Social Functioning Score: a higher score means better health Pain Score: a lower score means better health General health Score: a higher score means better health
Time Frame
4 weeks
Title
Leeds Dyspepsia Questionnaire as measured by total score at week-4
Description
Overall score is calculated from subject rating for frequency and severity responses for each symptom of dyspepsia. a summed total score of the frequency and severity responses for each symptom( Indigestion, heartburn, regurgitation, nausea combined) range: 0-32). 0= least severe.32= most severe each symptom = indigestion, regurgitation, heartburn and nausea a summed score of the frequency responses for each symptom (range: 0-16); a summed score of the severity responses for each symptom (range: 0-16); a categorized score of the single most frequent symptom (range: 0-4) and a categorized score of the single most severe symptom (range: 0-4).
Time Frame
4 weeks
Title
Profile of Mood States Questionnaire (POMS) as measured by score at week-4.
Description
Overall score assess changes in mood Not at all= 0 little = 1 Moderately = 2 Quite a lot = 3 Extremely = 4 Answers are combined. Higher the score for negative feelings i.e. tense the worse the mood. Higher the score for positive feelings i.e. Energetic the better the mood.
Time Frame
4 weeks
Title
Beck's Depression Inventory as measured by score at week-4.
Description
Overall score indicates severity of depressive symptoms 1-10 = These ups and downs are considered normal 11-16__ Mild mood disturbance 17-20__Borderline clinical depression 21-30_Moderate depression 31-40_Severe depression over 40__________________Extreme depression
Time Frame
4 weeks
Title
Cortisol awakening response (nmol/L) at week-4.
Description
Measures salivary cortisol (nmol/L)
Time Frame
4 weeks
Title
Reduction in medication to manage number of episodes requiring medication for dyspeptic symptoms as measured at week-4
Description
Number of times medication is taken to manage dyspeptic symptoms
Time Frame
4 weeks
Title
Safety as assessed by adverse events and serious adverse events ongoing throughout the trial
Description
Number of adverse events and serious adverse events
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy free-living men and women, Be aged 30 to 55 years (inclusive), Be willing to provide informed consent, Subject has upper abdominal pain or discomfort that is an unpleasant sensation, characterized by one or more of the following symptoms: early satiety, postprandial fullness, bloating, and nausea for at least 3 months during last year, without an identifiable underlying structural or biochemical motivation. Leeds Dyspepsia Questionnaire score 8 to 24 (mild-moderate) Beck's Depression Inventory score between 4 and 15 Exclusion Criteria: Pregnancy/lactation Subjects with relevant gastroesophageal reflux symptoms (retrosternal pain, burning, or regurgitation. Subjects with clear evidence of irritable bowel syndrome. Subjects under treatment with pharmacological substances that could influence the gastrointestinal system, such as prokinetics, ursodeoxycholic acid (UDCA), nonsteroidal anti-inflammatory drugs (NSAIDs), cholagogues, protonpump inhibitors, and H2 blockers, were asked to interrupt this treatment for one month before starting the study treatment. Subjects with previous diagnosis of cancer or with previous surgery of the upper gastro gastrointestinal endoscopy were performed in order to exclude the presence of structural or biochemical causes of dyspepsia. Participants are asked to avoid all foods containing ginger within the 14 days prior to study product administration and throughout the study. A list of foods high in ginger will be provided to subjects as a guide and this list will be reviewed at each visit. Subject with known allergy to components of the test product Any medical condition deemed exclusionary by the Principal Investigator Subject has a history of drug and / or alcohol abuse at the time of enrolment Change of dietary habit within the preceding month Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease Subject currently involved in any other clinical trial or having participated in a trial within the preceding 60 days, Subject has any concurrent medical or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements, Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation/severe, difficulty swallowing) Subject has a history of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years, Subject has a significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude supplement ingestion and/or assessment of safety and the study objectives,
Facility Information:
Facility Name
Atlantia CRO, Heron House
City
Blackpool
State/Province
Munster
ZIP/Postal Code
T23R50R
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All data will remain proprietary and will only be shared with Naturex (commercial partner) and contract statisticians.

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Effect of Gingest on Symptoms of Dyspepsia

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