Study on the Effect of Rhubarb Extract on Stool Frequency and Biological Markers of Intestinal Function in Seniors With Low Defecation

NCT05541991 | Completed DMC

• 1 other identifier: C1486
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized double-blind clinical study versus placebo evaluating the effect of supplementation with rhubarb extract on stool frequency and biological markers of intestinal function in seniors with a low number of defecations per week

Conditions

Constipation - Functional

Outcome Measures

Primary Outcomes (1)

• change of the number of defecations per week

  The main objective was to evaluate the effect of rhubarb extract supplementation on changing intestinal transit in subjects with a low number of defecations per week.

  Daily from Day -14 until the selection visit (Day 0) and every day during the 30days of treatment (until Day +30)

Secondary Outcomes (18)

• changes in the appearance of the stool

  Daily from Day -14 until the selection visit (Day 0) and every day during the 30days of treatment (until Day +30)

• the change of the quality of life

  measured at Day -14 and Day +30 of the treatment

• the evolution of biological markers of intestinal function

  measured at Day 0 and Day +30 of the treatment

• the evolution of the biological marker of intestinal function, active GLP-1

  measured at Day 0 and Day +30 of the treatment

• the evolution of the biological marker of intestinal function, total GIP

  measured at Day 0 and Day +30 of the treatment

Study Arms (3)

Single dose product

EXPERIMENTAL

A single dose coated tablet with standardised rhubarb extract is administrated daily in the evening during 30days

Dietary Supplement: single dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract

Double dose product

EXPERIMENTAL

A double dose coated tablet with standardised rhubarb extract is administrated daily in the evening during 30days

Dietary Supplement: double dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract

placebo product

PLACEBO COMPARATOR

A placebo coated tablet without active is administrated daily in the evening during 30days

Dietary Supplement: placebo coated tablet

Interventions

single dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract DIETARY_SUPPLEMENT

coated tablet with a single dose of standardised rhubarb extract

Single dose product

placebo coated tablet DIETARY_SUPPLEMENT

coated tablet without active principle

placebo product

double dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract DIETARY_SUPPLEMENT

coated tablet with a double dose of standardised rhubarb extract

Double dose product

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stools often (at least 25% of defecations according to the Rome III questionnaire) hard or lumpy, according to the bristol scale, at least the last 3 months over a period of 6 months;
• not currently justifying, according to his attending physician, drug treatment;
• Giving free and informed consent to the study in writing.

You may not qualify if:

• Related to the patient:
• subject who has not been screened for colon cancer in the past two years;
• subject participating in another therapeutic trial;
• subject with a serious general pathology and in particular renal or hepatic insufficiency, cancer, chronic pancreatitis;
• premenopausal women;
• subject with known hypersensitivity to one of the constituents of the product under study;
• subject who does not have the legal or ethical capacity to contract due to an impairment of his cognitive functions;
• subject likely not to be compliant with the constraints imposed by the protocol;
• subject not benefiting from a health insurance scheme.
• Related to the disorders assessed:
• subject having taken in the 30 days preceding the screening visit or currently taking medication, food supplements and any food enriched or presented as containing substances, bacteria or yeasts likely to have an effect on the intestines and more particularly on intestinal transit, digestive comfort, gas production, the occurrence of abdominal pain. These products were also prohibited throughout the duration of the study;
• subject following a particular diet (vegetarian, vegan, high protein, etc.);
• subject on a low-calorie diet and monitored by a current or recent doctor or dietitian (\< 6 weeks);
• subject undergoing medical treatment which, according to the investigator, could interfere with the evaluation of the study criteria: antibiotic, corticosteroid, anticholinergic, antidepressant, antiemetic, antihistamine, diuretic, calcium channel blocker, antiparkinsonian, antipsychotic, antacid, analgesic , NSAIDs, H2 receptor antagonist, hypnotic, sedative, iron supplement, opioid and narcotic, laxative, anti-diarrheal, anti-reflux;
• subject with an alcohol consumption greater than 3 glasses of wine per day, or two pints of beer per day, or one glass of strong alcohol per day;

Sponsors & Collaborators

• ortis: lead
• CEN Biotech: collaborator

Study Sites (1)

CEN nutriment

Dijon, 21000, France

Location

Study Officials

• Francois-andré Allaert

  CEN Nutriment

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized double-blind clinical study versus placebo

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 15, 2022
• Study Start: February 10, 2017
• Primary Completion: March 14, 2018
• Study Completion: June 13, 2018
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)