Clinical trial NCT03548363: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dyspepsia
Epigastric Fullness
Bloating
Epigastric Pain
Lead sponsor: Atlantia Food Clinical Trials
Sponsor class: INDUSTRY
Collaborators: name: Givaudan France Naturals
First posted: 2018-06-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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).

Eligibility criteria: 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,

Primary outcomes:
measure: Intensity of functional dyspepsia symptom score over 4-weeks as measured by subject rating score at week-4
timeFrame: 4-weeks
Secondary outcomes:
measure: Intensity of functional dyspepsia symptoms over 2-weeks as measured by subject rating score
timeFrame: 2-weeks
measure: Severity of dyspeptic symptoms as measured by subject severity score measured at week-4.
timeFrame: 4-weeks
measure: Participant Global Assessment as measured by Participant Global Assessment Score at week-4
timeFrame: 4 weeks
measure: Leeds Dyspepsia Questionnaire as measured by total score at week-4
timeFrame: 4 weeks
measure: Profile of Mood States Questionnaire (POMS) as measured by score at week-4.
timeFrame: 4 weeks
measure: Beck's Depression Inventory as measured by score at week-4.
timeFrame: 4 weeks
measure: Cortisol awakening response (nmol/L) at week-4.
timeFrame: 4 weeks
measure: Reduction in medication to manage number of episodes requiring medication for dyspeptic symptoms as measured at week-4
timeFrame: 4 weeks
measure: Safety as assessed by adverse events and serious adverse events ongoing throughout the trial
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Blackpool
country: Ireland
facility: Atlantia CRO, Heron House
state: Munster
Study officials:
References: