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Study Title and Description

Effects of isomalt consumption on gastrointestinal and metabolic parameters in healthy volunteers.



Key Questions Addressed
1 What is the relationship between low-calorie sweeteners and body weight and composition in randomized controlled studies?
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Primary Publication Information
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TitleData
Title Effects of isomalt consumption on gastrointestinal and metabolic parameters in healthy volunteers.
Author Gostner A., Schäffer V., Theis S., Menzel T., Lührs H., Melcher R., Schauber J., Kudlich T., Dusel G., Dorbath D., Kozianowski G., Scheppach W.
Country Department of Medicine, University of Würzburg, Josef-Schneider-Strasse 2, D-97080 Würzburg, Germany. gostner_a@klinik.uni-wuerzburg.de
Year 2005
Numbers Pubmed ID: 16197583
13295 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Extraction form for randomized controlled trials
Arms
No arms have been defined in this extraction form.

Design Details
Question... Follow Up Answer Follow-up Answer
Author, year Gostner, 2005
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Country Germany
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Baseline age range (y) or mean (SD) 21-53
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Children, Adolescents, or Adults Adults
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Other population characteristics Generally healthy, normolipidemic (n=13) and hyperlipidemic (n=6)
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Baseline BMI (mean) NR
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Intervention details RCT, double-blind, cross-over with 2 x 4 wk periods; identical controlled diets other than isomalt or sucrose (typical Western, low fiber, high fat)
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Tx arm Participants received 30g/d isomalt in marmalade, junket, yogurt, biscuits, chocolate, puddings and candies as part of controlled diet (typical Western diet, low fiber, high fat)
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Beverage (B), Food (F), or Supplement (S) F
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Weight loss diet in tx? N
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Control arm Participants received 30g/d sucrose in marmalade, junket, yogurt, biscuits, chocolate, puddings and candies as part of controlled diet (typical Western diet, low fiber, high fat)
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Weight loss diet in control? N
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Energy intake significantly less in tx? N
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Duration (wk) 4
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No. analyzed (tx) 19
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No. analyzed (control) 19
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Intake of sweetener (tx) mean (SD) 30 g/d
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Sex (M, F) 7 M, 12 F
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Outcome measure 1 Body weight (kg)
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Outcome measure 2
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Outcome measure 3
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Outcome measure 4
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Pre-study mean outcome 1 (tx) NA
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Pre-study mean outcome 2 (tx)
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Pre-study mean outcome 3 (tx)
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Pre-study mean outcome 4 (tx)
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Pre-study SD outcome 1 (tx) NA
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Pre-study SD outcome 2 (tx)
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Pre-study SD outcome 3 (tx)
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Pre-study SD outcome 4 (tx)
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Post-study mean outcome 1 (tx) NA
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Post-study mean outcome 2 (tx)
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Post-study mean outcome 3 (tx)
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Post-study mean outcome 4 (tx)
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Post-study SD outcome 1 (tx) NA
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Post-study SD outcome 2 (tx)
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Post-study SD outcome 3 (tx)
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Post-study SD outcome 4 (tx)
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Pre-study mean outcome 1 (control) NA
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Pre-study mean outcome 2 (control)
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Pre-study mean outcome 3 (control)
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Pre-study mean outcome 4 (control)
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Pre-study SD outcome 1 (control) NA
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Pre-study SD outcome 2 (control)
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Pre-study SD outcome 3 (control)
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Pre-study SD outcome 4 (control)
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Post-study mean outcome 1 (control) NA
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Post-study mean outcome 2 (control)
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Post-study mean outcome 3 (control)
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Post-study mean outcome 4 (control)
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Post-study SD outcome 1 (control) NA
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Post-study SD outcome 2 (control)
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Post-study SD outcome 3 (control)
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Post-study SD outcome 4 (control)
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Mean change outcome 1 (tx) -1.2
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Mean change outcome 2 (tx)
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Mean change outcome 3 (tx)
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Change SD outcome 1 (tx) 1.31
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Change SD outcome 2 (tx)
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Change SD outcome 3 (tx)
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Mean change outcome 1 (control) -1.2
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Mean change outcome 2 (control)
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Mean change outcome 3 (control)
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Change SD outcome 1 (control) 0.87
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Change SD outcome 2 (control)
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Change SD outcome 3 (control)
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Notes Note, body weight was measured but not an outcome of interest; if participants lost weight, they were provided with extra kcal formula
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Baseline Characteristics
No baseline characteristics have been defined for this extraction form.



Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Comments

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