DyspepsiaGIGINCT06446921
The Effect of a Ginger Supplement on Digestive Complaints in Healthy Adults Versus a Placebo
A study testing Ginger formula in people with Dyspepsia, run by Givaudan France Naturals.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Ginger formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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1 (too low) at V1 will be withdrawn from the study.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.
Who cannot join
- 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)
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- 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
- Subjects under treatment of antibiotics within the last 2 months before V0
- Subjects accustomed to use an anti-acid more than 3 times a week and not willing to refrain any consumption of these during the study
- Subjects under treatment of systemic corticoids within the last 3 months before V0 and not willing to refrain their use during the study
- Recent gastroenteritis or food borne illness such as confirmed food poisoning within the last 1 month before V0
- Under dietary supplement or treatment which could significantly affect parameters followed during the study according to the investigator (i.e. with laxative effect, with antidiarrheal effect, containing plant extracts (including ginger extracts), any formulation for digestive health, probiotics, prebiotics, symbiotic, vitamins and minerals) within the last 6 weeks before V0 or not willing to refrain from their consumption during the study
- Subjects used to consume any food and/or drink and/or condiment containing ginger (gari, pickled ginger, Japanese food, tea or infusion…) defined as more than 4 times a week before the study
- Subjects who do not agree to limit any ginger consumption during the study to maximally 4 times a week during the study
- With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredients and/or for the subgroup (with the gastric emptying test) to any components of the standard meals
- Pregnant or breastfeeding females, or wishing to become pregnant during the study
- With significant change of dietary habits or trying to lose weight within the last 3 months before V0 or planning to change dietary habits during the study or with eating disorders as per investigator judgement
- Following any specific diet such as high-protein, vegan, hypocaloric, ketogenic diet low in FODMAPs (Fructo-, Oligo, Di-Monosaccharides, And Polyols) except for vegetarian which is allowed
- Any change in the physical activity within the last 3 months before V0 or planning to change during the study or participant near or in the peak of training for an athletic race or competition
- Ongoing abuse of drugs, alcohol and / or medication at V0 or history of substance abuse within the last 12 months before V0
- Drinking more than 2 glasses of alcohol per day, every day and without interruption
- Smoking > 10 cigarettes per day
- Heavy caffeinated beverage consumption (>400 mg caffeine/day, i.e. more than 3 mugs of filter coffee or 4 espressos) within the last 2 weeks before V0 and during the study
- Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements
- Participation in any other clinical trial within the last 30 days before V0 and during the study
- Clinically relevant deviations from safety laboratory parameters (see section 11.8.3)
Trial locations and contacts
No sites are listed yet.
Geraldine Krausz, phD contact
About this study
Official title: The Effect of a Ginger Formulation Supplementation on Gastrointestinal Complaints in Healthy Adults: A Randomized, Doubleblind, Placebo Controlled Trial
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
- Being tested
- Ginger formula, Placebo
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginger formulaDietary supplement
supplement delivering a minimum of 20 mg of gingeroids / d
PlaceboDietary supplement
arabic gum
| Study group | Role | What they receive |
|---|---|---|
| Ginger formula | Experimental | 100 mg of ginger formula per capsule 2 capsules per day during 8 weeks Receives: Dietary Supplement: Ginger formula |
| Placebo formula | Placebo comparator | 2 capsules per day during 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The Short Form (SF) Nepean Dyspepsia Index is a 10-item questionnaire with 5 sub-scales each examining the influence of dyspepsia on domains of health in subjects, namely tension/anxiety, interference with daily activities, disruption to regular eating/drinking, knowledge towards/control over disease symptoms and interference with work/study, with each sub-scale containing two items. Each item is measured by a 5-point Likert scale ranging from 0 (not at all or not applicable), 1 (a little), 2 (moderately), 3 (quite a lot) to 4 (extremely) scores.
Measured: monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months
Overall Treatment Effect (OTE)
Subjects instructed to answer the question: "How were your gastric symptoms during the past week in comparison with the baseline period preceding the intake of the food supplement? " (7 point Likert scale)
Measured: monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months
Gastric emptying
The gastric emptying breath test is a standard tool to measure gastric emptying rate in subjects with dyspeptic symptoms. After eating, subjects will provide a breath sample and will score the severity (0: absent - 4: very severe) of 6 epigastric symptoms (fullness, bloating, nausea, epigastric pain, burning, and belching) every 15 minutes until 4 hours postprandially.
Measured: twice : basal at visit V1 (randomization) and after 2 months
Chalder fatigue scale
Each of the 11 items are answered on a 4-point scale ranging from asymptomatic to maximum symptomatology. Using the Likert scoring method, responses on the extreme left receive a score of 0, increasing to 1, 2 or 3 as they become more symptomatic. The respondent's global score can range from 0 to 33. The global score also spans two dimensions-physical fatigue (measured by items 1-7) and psychological fatigue (measured by items 8-11). The Likert scoring system allows for means and distributions to be calculated for both the global total as well as the two sub-scales.
Measured: monthly, from the day of randomization visit (V1) till end of study visit (V3) after 8 weeks
Perceived stress scale (PSS-10)
The PSS-10 is a self-questionnaire comprising 10 items and allowing each item to be evaluated on its frequency of occurrence during the previous month using a 5-point scale ranging from 0 = never to 4 = very often (Cohen \& Williamson, 1988; Bellinghausen, 2009). The PSS-10 consists of 10 items from the PSS-14 (items 1, 2, 3, 6, 7, 8, 9, 10, 11, and 14). The PSS-10 allows the assessment of perceived stress without any loss of psychometric quality.
PSS-10 scores are obtained by reversing responses (e.g., Never = 4, Almost Never = 3, Sometimes = 2, Fairly Often = 1, Very Often= 0) to the four positively stated items (items 4, 5, 7 and 8 from the PSS-10, corresponding to items 6, 7, 9 and 10 from the original PSS-14) and then summing across all scale items.
Individual scores on the PSS-10 can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized placebo controlled double blind trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Givaudan France Naturals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize, University Hospital of Leuven Leuven
- Responsible party
- Sponsor
- Investigators
- Tim Vanuytsel, Pr, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446921
- Sponsor's protocol ID
- GIV/010123
- Acronym
- GIGI
- Status last verified
- May 2024
- First submitted
- 23 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Ginger Formulation Supplementation on Gastrointestinal Complaints in Healthy Adults: A Randomized, Doubleblind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT06446921
- Acronym / sponsor ID
- GIGI / GIV/010123
- Conditions
- Dyspepsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Givaudan France NaturalsIndustry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize, University Hospital of Leuven Leuven
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized placebo controlled double blind trial
| Arm | Type | Receives |
|---|---|---|
| Ginger formula | Experimental | Dietary Supplement: Ginger formula100 mg of ginger formula per capsule 2 capsules per day during 8 weeks |
| Placebo formula | Placebo comparator | Dietary Supplement: Placebo2 capsules per day during 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (34 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginger formulasupplement delivering a minimum of 20 mg of gingeroids / d | Dietary supplement | Ginger formula |
| Placeboarabic gum | Dietary supplement | Placebo formula |
Primary outcome
Leuven Postprandial Distress scale (LPDS)
Time frame: daily, up to 66 days after the day of inclusion. from the day after inclusion until 8 weeks after randomization visit
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.
5 secondary outcomes
Short Form Nepean Dyspepsia Index (SF-NDI)
Time frame: monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months
Overall Treatment Effect (OTE)
Time frame: monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months
Gastric emptying
Time frame: twice : basal at visit V1 (randomization) and after 2 months
Chalder fatigue scale
Time frame: monthly, from the day of randomization visit (V1) till end of study visit (V3) after 8 weeks
Perceived stress scale (PSS-10)
Time frame: monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geraldine Krausz, phD contact
Tim Vanuytsel, Pr principal investigator
UZ Leuven
Questions about this trial
What is this clinical trial studying?
A study testing Ginger formula in people with Dyspepsia, run by Givaudan France Naturals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Gensch (49 176 44435206, agensch@a-r.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leuven Postprandial Distress scale (LPDS) (time frame: daily, up to 66 days after the day of inclusion. from the day after inclusion until 8 weeks after randomization visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.