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
The main objective was to evaluate the effect of rhubarb extract supplementation on improving intestinal transit in subjects with a low number of defecations per week. The secondary objectives are to assess: changes in the appearance of the stool; the evolution of the quality of life; the evolution of biological markers of intestinal function; the evolution of the intestinal microbiota; the evolution of low-grade chronic inflammatory markers; the evolution of endotoxemia; the evolution of oxidative stress; the relief experienced; subject satisfaction; the evolution of safety dosages; subject compliance. The main efficacy criterion is the improvement in intestinal transit assessed by the frequency of stool emissions reported daily from D-14 to D 30. The secondary endpoints correspond to the evolution of the aspect of the stools evaluated by the Bristol Stool Scale and the evolution of the quality of life evaluated by the SF-12. They also correspond to the relief of the subjects evaluated on the PGII scale, to the tolerance of the product over the entire study period and in particular the occurrence of diarrhea and to the description of satisfaction on a Likert scale. Regarding the biological assays, they correspond to: * for biological markers of intestinal function to those specific to intestinal transit, i.e. active GLP-1, total GIP total PYY, PP (DPPIV substrates), Leptin, Insulin, by blood samples at D0 and D30 and that specific for permeability intestinal or claudin-3 by urine samples at D0 and D30; * for the microbiota, analysis of bacterial taxa by PCR and metagenomics carried out on faecal samples collected on D0 and D30; * for chronic low-grade chemokine inflammatory markers, Prostaglandins, interleukins, pro- and anti-inflammatory cytokines, ultra-sensitive CRP by blood samples at D0 and D30; * for the measurement of endotoxaemia in the analysis of circulating LPS, TRL2 and 4 by blood samples on D0 and D30; * for the measurement of oxidative stress to the ROS and NADPH oxidase content by blood serum samples at D0 and D30; * for the safety assays for the lipid profile, NFS, glycaemia, kalemia, transaminases by blood samples on D0 and D30. The studied product is a food supplement composed of a rhubarb extract standardized, characterized and optimized in order to improve these functional effects on the intestinal system (regulation of the local inflammatory system, microflora, peristalsis, etc.) at 2 different doses. The food supplement comes in the form of a film-coated tablet. The comparator product was a placebo with an appearance strictly identical to the verum and contains only excipients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
45
coated tablet with a single dose of standardised rhubarb extract
coated tablet without active principle
coated tablet with a double dose of standardised rhubarb extract
CEN nutriment
Dijon, France
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.
Time frame: Daily from Day -14 until the selection visit (Day 0) and every day during the 30days of treatment (until Day +30)
changes in the appearance of the stool
This secondary criteria correspond to the evolution of the aspect of the stools evaluated by the Bristol Stool Scale
Time frame: 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
the evolution of the quality of life is evaluated by the General quality of life score, not specific to a pathology (SF-12).
Time frame: measured at Day -14 and Day +30 of the treatment
the evolution of biological markers of intestinal function
for biological markers of intestinal function, this corresponds to those specific specific to intestinal permeability claudin-3 by urine samples at D0 and D30
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, active GLP-1
for the biological marker of intestinal function: active GLP-1, this corresponds to those specific to intestinal transit, by blood samples at Day 0 and Day 30
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, total GIP
for the biological marker of intestinal function: total GIP, this corresponds to those specific to intestinal transit, by blood samples at Day 0 and Day 30
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Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, total PYY
for the biological marker of intestinal function: total PYY, this corresponds to those specific to intestinal transit, by blood samples at Day 0 and Day 30
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, PP (DPPIV substrates)
for the biological marker of intestinal function: PP (DPPIV substrates), this corresponds to those specific to intestinal transit, by blood samples at Day 0 and Day 30
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, Leptin
for the biological marker of intestinal function: total Leptin, this corresponds to those specific to intestinal transit, by blood samples at Day 0 and Day 30
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, Insulin
for the biological marker of intestinal function: total Insulin, this corresponds to those specific to intestinal transit, by blood samples at Day 0 and Day 30
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the intestinal microbiota by PCR
for the microbiota, this corresponds to the analysis of bacterial taxa by PCR carried out on faecal samples collected on D0 and D30
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the intestinal microbiota by metagenomics
for the microbiota, this corresponds to the analysis of bacterial taxa by metagenomics carried out on faecal samples collected on D0 and D30
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of low-grade chronic inflammatory markers
for low-grade chronic inflammatory markers, this corresponds to the dosage of chemokines, Prostaglandins, interleukins, pro- and anti-inflammatory cytokines, ultra-sensitive CRP by blood samples at D0 and D30
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of endotoxemia
for the measurement of endotoxemia, this corresponds to the analysis of circulating LPS, TRL2 and 4 by blood samples on D0 and D30
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of oxidative stress
for the measurement of oxidative stress, this corresponds to the ROS and NADPH oxidase content by blood serum samples at D0 and D30;
Time frame: measured at Day 0 and Day +30 of the treatment
the relief experience
It corresponds to the relief of the subjects evaluated on the Patient Global Impression of Improvement scale (PGII scale)
Time frame: measured at Day +30 of the treatment
subject satisfaction
It corresponds to the tolerance of the product over the entire study period and in particular the occurrence of diarrhea and to the description of satisfaction on a Likert scale.
Time frame: measured at Day +30 of the treatment
the evolution of the incidence of treatment
for the evolution of the incidence of treatment, this corresponds to the lipid profile, NFS, glycaemia, kalemia, transaminases by blood samples on D0 and D30.
Time frame: measured at Day 0 and Day +30 of the treatment
subject compliance for taking the product
Unused products are collected to assess compliance by measuring the number of unused product
Time frame: measured at Day +30 of the treatment