Phase 3
Completed N=119
Safety and Efficacy of IQP- AK-102 in Reducing Body Weight
Source: ClinicalTrials.gov NCT01905956 ↗Enrolled (actual)
119
Serious AEs
0.9%
Results posted
Mar 2016
Primary outcomePrimary: Mean Change in Body Weight From Baseline to Week 12 — 3.53; 0.14 kilogram (kg)
Summary
The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several studies demonstrating their efficacy, we are conducting this study to look into the efficacy and safety of this novel combination of three fibres, in appetite regulation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Body Weight From Baseline to Week 12 |
3.53; 0.14 | — |
| SECONDARY Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12 |
2.12; 0.92; 2.25; 1.07 | — |
| SECONDARY Mean Change in Body Fat Content (%) From Baseline to Week 12 |
0.95; 0.08 | — |
| SECONDARY Mean Change in Body Fat Mass (kg) From Baseline to Week 12 |
1.32; 0.05 | — |
| SECONDARY Food Craving Questionnaire (FCQ) |
2.65; 2.74; 2.17; 2.47; 1.98; 2.34 | — |
| SECONDARY Global Evaluation of Efficacy by the Investigators |
31; 1; 18; 6; 4; 19 | — |
| SECONDARY Global Evaluation of Efficacy by the Subjects |
28; 1; 22; 6; 4; 22 | — |
| SECONDARY Global Evaluation of Safety by the Investigators |
46; 35; 6; 7; 0; 1 | — |
| SECONDARY Global Evaluation of Safety by the Subjects |
46; 37; 7; 7; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 65 years
- 25≤BMI≤35
- Expressed desire for weight loss
- Accustomed to 3 main meals/day
- Generally in good health
- Consistent and stable body weight 3 months prior to study enrolment
- Consistent regular physical activity
- Commitment to avoid the use of other weight loss products during study
- Commitment to adhere to diet and lifestyle recommended for the study
Exclusion Criteria
- Known sensitivity to the ingredients of the device
- Presence of any active gastrointestinal disease
- Malabsorption disorders
- Pancreatitis
- Stenosis in the GI tract
- Bariatric surgery
- Any other reason deemed suitable for exclusion, per investigator's judgement
Data sourced from ClinicalTrials.gov (NCT01905956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.