The Effect of a Ginger Supplement on Digestive Complaints in Healthy Adults Versus a Placebo

NCT06446921 | Not Yet Recruiting

• 1 other identifier: GIV/010123
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this clinical study is to investigate the effect of a ginger formulation as a dietary supplement on gastrointestinal complaints in healthy adults. The effect of this formula will be compared to a placebo after 8 weeks of consumption.

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Leuven Postprandial Distress scale (LPDS)

  The LPDS is a questionnaire consisting of eight items: early satiation, postprandial fullness, upper abdominal bloating, epigastric pain, epigastric burning, nausea, belching and heartburn. Each symptom will be rated on a 5-point Likert-type scale: absent=0, mild=1, moderate=2, severe=3 and very severe=4 over a period of one day.

  daily, up to 66 days after the day of inclusion. from the day after inclusion until 8 weeks after randomization visit

Secondary Outcomes (5)

• Short Form Nepean Dyspepsia Index (SF-NDI)

  monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months

• Overall Treatment Effect (OTE)

  monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months

• Gastric emptying

  twice : basal at visit V1 (randomization) and after 2 months

• Chalder fatigue scale

  monthly, from the day of randomization visit (V1) till end of study visit (V3) after 8 weeks

• Perceived stress scale (PSS-10)

  monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months

Study Arms (2)

Ginger formula

EXPERIMENTAL

100 mg of ginger formula per capsule 2 capsules per day during 8 weeks

Dietary Supplement: Ginger formula

Placebo formula

PLACEBO COMPARATOR

2 capsules per day during 8 weeks

Dietary Supplement: Placebo

Interventions

Ginger formula DIETARY_SUPPLEMENT

supplement delivering a minimum of 20 mg of gingeroids / d

Ginger formula

Placebo DIETARY_SUPPLEMENT

arabic gum

Placebo formula

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18-65 years
• Body Mass Index (BMI) 18.5 - 30.0 kg/m2 (limits included)
• Otherwise healthy subjects with Postprandial Distress Syndrome (PDS) as defined by ROME IV criteria: Must include one or both of the following criteria\* at least 3 days a week: - Bothersome postprandial fullness (i.e. severe enough to impact on usual activities)
• Bothersome early satiation (i.e. severe enough to prevent finishing a regular size meal)
• \*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis with no apparent evidence of organic, systemic or metabolic disease or structural disease by standard clinical examination by the investigator at V0 that is likely to explain the complaints
• Documented Helicobacter pylori negative subjects according to a validated previous test (histological, breath, stool antigen or serological test) in the last 5 years or if not, with a rapid assay realized during V0
• Negative urine pregnancy test for women in childbearing age at V0 At V1, after 1-week diary completion, mean "PDS score" on LPDS scale ≥ 1 and \<3 (mild and moderate) As per this randomization criterion, any subjects with a "PDS score" of ≥3 (severe or very severe) or \<1 (too low) at V1 will be withdrawn from the study.
• For assessment of PDS, the last 7 consecutive days before V1 should be used to calculate the score.

You may not qualify if:

• Subjects with dominant Epigastric Pain Syndrome (EPS) (as per Rome IV criteria) as main complaints at V0 as per investigator's judgement
• Subject with a dominant Irritable Bowel Syndrome (IBS) as per Rome IV criteria at V0 as per investigator's judgement
• Subjects suffering from or with history of dominant gastroesophageal reflux disease (GERD)-like symptoms at V0 as per investigator's judgement
• Self-reported organic findings in endoscopy in the last 5 years (if any) likely to explain dyspeptic symptoms
• Subject with other chronic gastrointestinal (GI) disorders (e.g. inflammatory bowel disease, coeliac disease)
• History of major gastrointestinal surgery (except for appendectomy or cholecystectomy)
• Suffering from or history of severe chronic disease in the last 5 years (e.g. cancer, HIV, hepatic or biliary disorders ongoing, pancreatic disease, kidney disease, uncontrolled cardiovascular disease, or chronic respiratory diseases) (self-reported)
• Presence of an organic cause explaining the dyspeptic complaints (e.g. peptic ulcer disease or parasitic infection) (self-reported)
• Family history of oesophageal or gastric cancer
• Subjects with diabetes (self-reported)
• Subjects with PHQ-9 (PATIENT HEALTH QUESTIONNAIRE)(score over 15 at V0
• Subjects with GAD-7 (Generalized Anxiety Disorder 7-item) score over 15 at V0
• Active psychiatric conditions (stable dose of 1 antidepressant is allowed, no other medication for psychiatric conditions)
• Subjects under treatment for dyspepsia complaints such as Proton Pump Inhibitors (PPI), Histamine 2 receptor antagonists (H2RAs), prokinetics, within the last 6 weeks before V0 and during the study and not willing to refrain their use during the study
• Subjects under opioids or immunosuppressants (antihistaminics and topical corticosteroids (nasal sprays, cutaneous) are allowed) or Non-steroidal anti-inflammatory drugs (NSAIDS) within the last 2 weeks before V0 and during the study and not willing to refrain their use during the study

Sponsors & Collaborators

• Givaudan France Naturals: lead
• Analyze & Realize: collaborator
• University Hospital of Leuven Leuven: collaborator

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

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

Study Officials

• Tim Vanuytsel, Pr

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Gensch

CONTACT

49 176 44435206; agensch@a-r.com

Geraldine Krausz, phD

CONTACT

geraldine.krausz@givaudan.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized placebo controlled double blind trial

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 6, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-05