Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome

NCT04484467 | Completed

• 1 other identifier: No. 418 dated 01/31/2018
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of a food supplement with standardized menthol, limonene, and gingerol content in patients with irritable bowel syndrome (IBS) or IBS/functional dyspepsia (FD).

Conditions

Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome With Constipation; Irritable Bowel Syndrome Mixed

Keywords

Functional dyspepsia

Outcome Measures

Primary Outcomes (1)

• Change in the severity of symptoms of irritable bowel syndrome (IBS) and functional dyspepsia (FD) (constipation-predominant, diarrhea-predominant, mixed-type IBS and IBS/FD)

  Symptom severity was tested with a "7x7" questionnaire at each visit.

  Visit 1 - Day 1, Visit 2 - Day 15 +- 2 days, and Visit 3 - Day 30 +- 2 days

Secondary Outcomes (1)

• Change in the number of SCFA producing bacteria

  Visit 1 - Day 1, Visit 3 - Day 30 + 2 days

Study Arms (2)

Food supplement Standart Zdorovya GASTRO

EXPERIMENTAL

In the intervention group (Group 1), the supplement "Standart Zdorovya GASTRO" (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days.

Dietary Supplement: Food Supplement With Standardized Menthol, Limonene, and Ginger

Placebo

PLACEBO COMPARATOR

In the control group (Group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days.

Other: Placebo

Interventions

Food Supplement With Standardized Menthol, Limonene, and Ginger DIETARY_SUPPLEMENT

Components of Standart Zdorovya GASTRO: Peppermint oil (40% menthol, 1.5% limonene) - 240 mg, Ginger oil (14% gingerol) - 50 mg, olive oil - 440 mg, 1 capsule, 730 mg, once a day for 30 days

Also known as: Standart Zdorovya GASTRO

Food supplement Standart Zdorovya GASTRO

Placebo OTHER

Components of placebo Olive oil - 730 mg, 1 capsule, 730 mg, once a day for 30 days

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• irritable bowel syndrome (IBS)
• diarrhea-predominant IBS
• constipation-predominant IBS
• mixed-type IBS
• IBS/functional dyspepsia symptoms
• Must be able to swallow tablets

You may not qualify if:

• organic bowel disease
• renal disease
• hepatic insufficiency,
• schizophrenia
• bipolar disorder
• epilepsy

Sponsors & Collaborators

• Federal Stare Budgetary Scientific Institution, Mental Health Research Center: lead
• I.M. Sechenov First Moscow State Medical University: collaborator
• RML INVEST, Torkhovsky passage 10, Tula, Russian Federation: collaborator

Study Sites (1)

Mental Health Research Center

Moscow, Russia

Location

Related Publications (1)

• Ivashkin VT, Kudryavtseva AV, Krasnov GS, Poluektov YM, Morozova MA, Shifrin OS, Beniashvili AG, Mamieva ZA, Kovaleva AL, Ulyanin AI, Trush EA, Erlykin AG, Poluektova EA. Efficacy and safety of a food supplement with standardized menthol, limonene, and gingerol content in patients with irritable bowel syndrome: A double-blind, randomized, placebo-controlled trial. PLoS One. 2022 Jun 15;17(6):e0263880. doi: 10.1371/journal.pone.0263880. eCollection 2022.

  PMID: 35704960 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Dietary Supplements; Limonene; ginger extract

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Monoterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Using a random number generator, 56 patients with IBS or IBS/FD were randomly assigned to either the intervention group (28 individuals) or control group (28 individuals). Researchers and patients were not informed who received a supplement or placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior research fellow, PHD

Model Details: At Visit 1, all patients were randomly assigned into two groups. In the intervention group (Group 1), the supplement "Standart Zdorovya GASTRO" (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days. In the control group (Group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days (Table 1). During the 30 days of the study, three outpatient visits were conducted (Visit 1 - Day 1, Visit 2 - Day 15 + 2 days, and Visit 3 - Day 30 + 2 days).

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: February 9, 2018
• Primary Completion: December 28, 2019
• Study Completion: December 28, 2019
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)