Effect of Gingest on Symptoms of Dyspepsia

NCT03548363 | Completed DMC

• 1 other identifier: AFCRO 085
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspepsia; Epigastric Fullness; Bloating; Epigastric Pain

Outcome Measures

Primary Outcomes (1)

• 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 1. Slightly improved 2. Markedly improved 3. Completely improved

  4-weeks

Secondary Outcomes (9)

• Intensity of functional dyspepsia symptoms over 2-weeks as measured by subject rating score

  2-weeks

• Severity of dyspeptic symptoms as measured by subject severity score measured at week-4.

  4-weeks

• Participant Global Assessment as measured by Participant Global Assessment Score at week-4

  4 weeks

• Leeds Dyspepsia Questionnaire as measured by total score at week-4

  4 weeks

• Profile of Mood States Questionnaire (POMS) as measured by score at week-4.

  4 weeks

Study Arms (3)

Gingest High

ACTIVE COMPARATOR

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

Dietary Supplement: Gingest powdered extract obtained from Ginger rhizomes

Gingest low

ACTIVE COMPARATOR

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

Dietary Supplement: Gingest powdered extract obtained from Ginger rhizomes

Placebo

PLACEBO COMPARATOR

200 mg/d maltodextrin for 4-weeks

Dietary Supplement: Placebo

Interventions

Gingest powdered extract obtained from Ginger rhizomes 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 High; Gingest low

Placebo DIETARY_SUPPLEMENT

200 mg/d maltodextrin

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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,

Sponsors & Collaborators

• Atlantia Food Clinical Trials: lead
• Givaudan France Naturals: collaborator

Study Sites (1)

Atlantia CRO, Heron House

Blackpool, Munster, T23R50R, Ireland

Location

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: June 7, 2018
• Study Start: March 13, 2018
• Primary Completion: January 2, 2019
• Study Completion: January 2, 2019
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)