Effect of Gingest on Symptoms of Dyspepsia

NCT ID: NCT03548363

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-13
• Study Completion Date: 2019-01-02

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).

Conditions

Dyspepsia; Epigastric Fullness; Bloating; Epigastric Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gingest High

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

Group Type: ACTIVE_COMPARATOR

Gingest powdered extract obtained from Ginger rhizomes

Intervention Type: DIETARY_SUPPLEMENT

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

Gingest low

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

Group Type: ACTIVE_COMPARATOR

Gingest powdered extract obtained from Ginger rhizomes

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

200 mg/d maltodextrin for 4-weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

200 mg/d maltodextrin

Interventions

Gingest powdered extract obtained from Ginger rhizomes

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

Placebo

200 mg/d maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Givaudan France Naturals

INDUSTRY

Sponsor Role: collaborator

Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Atlantia CRO, Heron House

Blackpool, Munster, Ireland

Countries

Ireland

Other Identifiers

AFCRO 085

Identifier Type: -

Identifier Source: org_study_id