| Methods |
Design: three group parallel trial
Purpose: examine the effect of 'guggulsterone phosphate compound' on the body composition and mood in obese adults |
| Participants |
Patients: out‐patients with body mass index >25 kg per square meter
Baseline comparability: yes |
| Interventions |
Placebo: maltodextrin capsules daily for 6 weeks
Untreated: no capsules
Experimental: capsules with a compound of guggulsterone phosphate
(Co‐intervention: dietary and exercise program) |
| Outcomes |
Weight (kg)
Lean body mass
Fat mass
Percentage body fat
Profile of Mood States questionnaire (POMS) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'In this double‐masked, randomized study...' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| 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 = 12 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
