TABLE 10.
Clinical trials that studied polydextrose consumption in adults without gastrointestinal disease1
| Study | Population | Design | Duration | Dose | Control (vehicle) | Treatment (vehicle) | Assessment | Responses |
|---|---|---|---|---|---|---|---|---|
| Kondo, 1996 (109) | Healthy adults in Japan (n = 5; 3 F, 2 M), 22–48 y | Postprandial | 6-h monitoring, each beverage on separate day | 7 g/d | 10.2 g/d lactulose (soft drink) | PDX (Nakakita Pharmaceuticals Sapitus 5289 soft drink) | Orocecal transit time, flatulence (no quantitative assessment) | Orocecal transit time was constant for all treatments and flatulence was common |
| Costabile, 2012 (110) | Healthy adults in the United Kingdom (n = 31; 16 F, 15 M), 18–50 y, BMI 19–25 | Placebo controlled, double blind, crossover | 2-wk lead-in, 3-wk treatments, 3-wk washout | 8 g/d | Maltodextrin (powder) | Danisco UK Litesse Ultra PDX (powder) | Bowel habits, quality of life | PDX ↓ abdominal discomfort and pain compared with control.2 |
| Monsivais, 2011 (112) | Healthy adults in the United States (n = 36; 22 F, 14 M), 20–34 y, BMI 18–30 | Double blind, preload | 6 testing days over 6 wk, ≥1 wk between sessions | 11.8 g preload provided twice | Isoenergetic, low-fiber preload and lower-energy, low-fiber preload (snack + beverage preload) | Sta-Lite III PDX (snack + beverage preload) | Computerized VAS to rate nausea at 20- min intervals | Nausea did not differ between preloads |
| Jie, 2000 (113) | Healthy adults in China (n = 120; 54 F, 66 M), 32.9 y (M) and 29.4 y (F) | Placebo controlled, randomized, double blind, 4-group parallel arm | 28 d | 4, 8, 12 g/d | 0 g/d PDX (blinded, not specified) | Danisco Litesse PDX (warm water) | Bowel function (frequency and ease of defecation) | PDX improved frequency and ease of defecation compared with control.2 |
| Hull, 2012 (114) | Healthy adults in the United Kingdom (n = 34; 24 F, 10 M), ≥18 y, BMI 18.5–25 | Randomized, single blind, placebo controlled, 3-period crossover | Over 3 wk, each participant visited test facility on 3 occasions (1-wk washout between each visit) | 6.25, 12.5 g/d | Glucose (strawberry flavor drinking yogurt) | DuPont Litesse PDX (strawberry flavor drinking yogurt) | Questions on liking drinks and discomfort symptoms (bloating, nausea, headache) using VAS | 6.25 g/d PDX ↑ bloating compared with control and 12.5 g/d PDX.2 6.25 g/d PDX ↓ belching compared with control.2 |
| Timm, 2013 (115) | Healthy adults in the United States (n = 36; 18 F, 18 M), ≥18 y, BMI 18.5–30 | Randomized, double blind, placebo controlled, crossover | 10-d treatments, 2-wk washout | 20 g/d | None (muffin and cereal) | Tate and Lyle STA-LITE PDX (muffin and cereal) | Fecal samples, gastrointestinal tolerance questionnaires | PDX ↑ fecal wet weight, frequency, flatulence, and borborygmi and softened stool compared with control.2 |
| Vester Boler, 2011 (116) | Healthy males in the United States (n = 21), 21–28 y, BMI 20–34 | Crossover | 21-d periods | 21 g/d | None (snack bar) | Danisco Litesse II PDX (snack bar) | Fecal samples, gastrointestinal symptoms | PDX ↑ flatulence compared with control.2 All tolerance scores were low (only slight discomfort) |
| Astbury, 2013 (117) | Healthy adults in the United Kingdom (n = 21; 12 M, 9F), 18–45 y, BMI 19–25 | Randomized, within subject, crossover | 4 visits, ≥7 d between visits | 6.3, 12.5, 25 g/d | Maltodextrin (chocolate-flavored liquid preload) | Danisco Litesse Ultra PDX (chocolate-flavored liquid preload) | Questionnaire on abnormal gastrointestinal symptoms or discomfort (e.g., bloating, nausea, loose bowel movement, flatulence) in 24 h after leaving lab | No reports of gastrointestinal distress |
| King, 2005 (118) | Healthy adults in the United Kingdom (n = 15; 8 F, 7 M), mean 30.1 y, mean BMI 22.7 | 4-period crossover, repeated measures | Four 10-d periods | 12.5, 25 g/d | Sucrose (yogurt) | Danisco Litesse PDX (yogurt) | Recorded experiences of bloating and nausea with VAS on days 1 and 10 of each period | No differences in bloating or nausea between treatments |
| Achour, 1994 (119) | Healthy males in France (n = 7), 27 ± 2 y, within 10% ideal body weight | Control phase, acute ingestion, chronic ingestion | 38 d | 30 g/d | None (controlled diet) | Pfizer PDX (fruit juice) | Transit time, abdominal symptoms | PDX did not change transit time or ↑ abdominal symptoms compared with control |
| Konings, 2014 (111) | Adults in the Netherlands (n = 18; 9 F, 9 M) who were overweight, 20–50 y, BMI 27.2 ± 0.4 (F) and 27.3 ± 0.5 (M) | Single blind, randomized, crossover | 4 treatment sessions, 1-wk washouts | 56.7 g/d | None (control diets) | Sta-lite PDX (control diet) | Well-being determined with questionnaire on symptoms of nausea, abdominal bloating, stomach-intestinal cramps, diarrhea, and other | No nausea, burping, headache, vomiting, or dizziness. Diarrhea was present in 1 female and 1 male with PDX |
1
BMI is presented as kg/m2. PDX, polydextrose; VAS, visual analog scale.
2
Differences were statistically significant (P ≤ 0.05).