The purpose of the present study was to establish the prebiotic effect of a new xylo-oligosaccharides (XOS) and of an inulin-and-XOS mixture (INU-XOS) and to determine their effect on endotoxaemia (lipopolysaccharides (LPS)) and immune parameters. In this randomized, parallel, placebo-controlled, double-blind study, sixty healthy volunteers were randomly assigned to three groups, receiving either 5 g XOS, INU-XOS (3 g inulin +1 g XOS) or an equivalent weight of wheat maltodextrins (placebo) during 4 weeks.
The study followed a randomized, parallel placebo-controlled double-blind design. A semi-quantitative dietary survey was performed at enrollment in order to assess the usual dietary fiber intake in order to select the target population consuming 13 to 18 g/day. The volunteers were instructed to follow dietary guidelines to maintain their fiber intake during a two-week stabilization phase and then throughout the intervention. As all volunteers were living on-site and taking all meals at the Institut Polytechnique LaSalle Beauvais cafeteria, the content of each meal could be closely controlled during the week. A 3-day dietary survey was performed at the end of the stabilization period and repeated at the end of the intervention in order to assess the stability of the diet. The 60 volunteers were randomly assigned to one of three groups and received daily the intervention for 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
60
Institut Polytechnique LaSalle Beauvais
Beauvais, Oise, France
Change from Baseline in the intestinal bifidobacterium at 4 weeks.
Dosage by count in the feces by Reverse transcription polymerase chain reaction (RT-PCR).
Time frame: 4 weeks
Change from Baseline in the intestinal bifidobacterium at 2 weeks.
Dosage by count in the feces by Reverse transcription polymerase chain reaction (RT-PCR).
Time frame: 2 weeks
Change from 2 weeks in the intestinal bifidobacterium at 4 weeks.
Dosage by count in the feces by Reverse transcription polymerase chain reaction (RT-PCR).
Time frame: Between 2 and 4 weeks
Change from Baseline in total microbiota and composition in the feces at 4 weeks.
Total bacterial count and specific bacterial profile analyzed by quantitative PCR.
Time frame: 4 weeks
Change from Baseline in total microbiota and composition in the feces at 2 weeks.
Total bacterial count and specific bacterial profile analyzed by quantitative PCR.
Time frame: 2 weeks
Change from 2 weeks in total microbiota and composition in the feces at 4 weeks.
Total bacterial count and specific bacterial profile analyzed by quantitative PCR.
Time frame: Between 2 and 4 weeks
Change from Baseline of short-chain fatty acids (C2, C3, C4) in the feces at 4 weeks
Acetic acid (C2), propionic acid (C3) and butyric acid (C4) extracted and measured.
Time frame: 4 weeks
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Change from Baseline of short-chain fatty acids (C2, C3, C4) in the feces at 2 weeks
Acetic acid (C2), propionic acid (C3) and butyric acid (C4) extracted and measured.
Time frame: 2 weeks
Change from 2 weeks of short-chain fatty acids (C2, C3, C4) in the feces at 4 weeks
Acetic acid (C2), propionic acid (C3) and butyric acid (C4) extracted and measured.
Time frame: Between 2 and 4 weeks
Change from Baseline in the alpha-glucosidase and beta-glucuronidase activities in the feces at 4 weeks.
Time frame: 4 weeks
Change from Baseline in the alpha-glucosidase and beta-glucuronidase activities in the feces at 2 weeks.
Time frame: 2 weeks
Change from 2 weeks in the alpha-glucosidase and beta-glucuronidase activities in the feces at 4 weeks.
Time frame: Between 2 and 4 weeks
Change from Baseline in the phenol and p-Cresol in the feces at 4 weeks.
Time frame: 4 weeks
Change from Baseline in the phenol and p-Cresol in the feces at 2 weeks.
Time frame: 2 weeks
Change from 2 weeks in the phenol and p-Cresol in the feces at 4 weeks.
Time frame: Between 2 and 4 weeks
Change from Baseline in the faecal pH and dry matter at 4 weeks.
Time frame: 4 weeks
Change from Baseline in the faecal pH and dry matter at 2 weeks.
Time frame: 2 weeks
Change from 2 weeks in the faecal pH and dry matter at 4 weeks.
Time frame: Between 2 and 4 weeks
Change from Baseline in secretory Immunoglobulin A (IgA) at 4 weeks.
Measured with s-IgA ELISA kit.
Time frame: 4 weeks
Change from Baseline in secretory Immunoglobulin A (IgA) at 2 weeks.
Measured with s-IgA ELISA kit.
Time frame: 2 weeks
Change from 2 weeks in secretory Immunoglobulin A (IgA) at 4 weeks.
Measured with s-IgA ELISA kit.
Time frame: Between 2 and 4 weeks
Change from Baseline in cytokines at 4 weeks
Tumor Necrosis Factor (TNF)-alpha and Interleukine(IL)-10
Time frame: 4 weeks
Change from Baseline in cytokines at 2 weeks
Tumor Necrosis Factor (TNF)-alpha and Interleukine(IL)-10
Time frame: 2 weeks
Change from 2 weeks in cytokines at 4 weeks
Tumor Necrosis Factor (TNF)-alpha and Interleukine(IL)-10
Time frame: Between 2 and 4 weeks
Change from Baseline in dietary intakes at 4 weeks
Data extracted from a 3-day food diary.
Time frame: 4 weeks
Change from Baseline in dietary intakes at 2 weeks
Data extracted from a 3-day food diary.
Time frame: 2 weeks
Change from 2 weeks in dietary intakes at 4 weeks
Data extracted from a 3-day food diary.
Time frame: Between 2 and 4 weeks
Change from Baseline of circulating lipopolysaccharides (LPS) at 4 weeks.
Measured in plasma sample using the limulus amebocyle lysate chromogenic endpoint assay.
Time frame: 4 weeks
Change from Baseline of circulating lipopolysaccharides (LPS) at 2 weeks.
Measured in plasma sample using the limulus amebocyle lysate chromogenic endpoint assay.
Time frame: 2 weeks
Change from 2 weeks of circulating lipopolysaccharides (LPS) at 4 weeks.
Measured in plasma sample using the limulus amebocyle lysate chromogenic endpoint assay.
Time frame: Between 2 and 4 weeks
Change from Baseline in the subjects' tolerance to the test products at 4 weeks.
Flatulence, bloating, rumbling, cramps, nausea, stool consistency on a Visual Analog Scale (10 cm).Stool frequency (stool per day).
Time frame: 4 weeks
Change from Baseline in the subjects' tolerance to the test products at 2 weeks.
Flatulence, bloating, rumbling, cramps, nausea, stool consistency on a Visual Analog Scale (10 cm). Stool frequency (stool per day).
Time frame: 2 weeks
Change from 2 weeks in the subjects' tolerance to the test products at 4 weeks.
Flatulence, bloating, rumbling, cramps, nausea, stool consistency on a Visual Analog Scale (10 cm). Stool frequency (stool per day).
Time frame: Between 2 and 4 weeks