| Methods |
Design: three group parallel trial
Purpose: examine the effect of high fibre intervention (guar gum) on serum lipoproteins and body weight |
| Participants |
Patients: out‐patients with hypercholesterolaemia
Baseline comparability: NS |
| Interventions |
Placebo: granule with no guar gum (wheat flower)
Untreated: no granule
Experimental: granule with guar gum
(Co‐intervention: diet instructions: decrease alcohol and fat, increase complex carbohydrates) |
| Outcomes |
Serum‐cholesterol: total (mmol/l)
Serum‐cholesterol: high density lipoprotein
Serum‐triglyceride
Weight
Blood pressure |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Blinding?
Treatment provider |
Low risk |
'... studied in a double‐blind controlled trial' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
High risk |
N = 22 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
