Long-term gastrointestinal tolerance of NUTRIOSE FB in healthy men.
OBJECTIVE
To determine the gastrointestinal (GI) tolerance of NUTRIOSE FB in men.


METHODS
A randomized, placebo-controlled, parallel, double-blind study.


METHODS
The metabolic ward of TNO Quality of Life.


METHODS
Forty-eight subjects started the study: 16 men participated in one of the three treatments. SUBJECTS consumed either 22.5 g of pure maltodextrin (Glucidex 6), or 30 or 45 g of the dextrin NUTRIOSE FB daily for 4-5 weeks. Forty-three subjects completed the study (age: 34.7 +/- 8.2 years; BMI 24.9 +/- 3.3 kg m2).


METHODS
Tolerance of NUTRIOSE FB was examined with a GI complaints questionnaire; effectiveness on colonic flora was examined by faecal analysis; fermentation by breath hydrogen excretion measurement. Furthermore, the effect on body weight (BW), energy intake and blood parameters were examined in the study.


RESULTS
Both doses of NUTRIOSE FB were very well tolerated and GI complaints hardly differed from the placebo treatment. No diarrhoea was reported due to NUTRIOSE FB supplementation. In the course of the study, some habituation and adaptation of GI symptoms were found. Fermentation and faecal characteristics (pH and enzyme activity) were significantly positively affected with NUTRIOSE FB treatment. Body weight in both NUTRIOSE FB groups remained stable over time, although the placebo-treated group showed a small increase in BW (Deltaday35-1 0.8 +/- 1.0 kg) (P = 0.07). However, total food intake and macronutrient composition of the diet remained the same throughout the study. No significant differences were found between the three treatment groups in hunger and satiety scores and food preferences.


CONCLUSIONS
Long-term supplementation of 30 or 45 g of the dextrin NUTRIOSE FB per day was well tolerated, and may act as a pre-biotic supplement.


BACKGROUND
TNO Quality of Life was assigned by Roquette Frères to perform the study.
Pasman
W
W
TNO Quality of Life, Zeist, The Netherlands. pasman@voeding@tno.nl
Wils
D
D
Saniez
M-H
MH
Kardinaal
A
A
D000222:Adaptation, Physiological; D000328:Adult; D001835:Body Weight / Q000187:drug effects*; D001944:Breath Tests; D003912:Dextrins / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D002149:Energy Intake / Q000187:drug effects*; D005243:Feces / Q000737:chemistry / Q000201:enzymology / Q000382:microbiology*; D005285:Fermentation; D006801:Humans; D008297:Male; D011134:Polysaccharides / Q000008:administration & dosage*; D019936:Probiotics / Q000008:administration & dosage; D011788:Quality of Life; D011795:Surveys and Questionnaires
D003912:Dextrins; D011134:Polysaccharides; C008315:maltodextrin