Phase 4 N=50 Randomized Quadruple-blind Treatment

Litramine in Weight Maintenance

Weight Maintenance · Overweight · Obese

Bottom Line

View on ClinicalTrials.gov: NCT01505387 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcome: Primary: Mean Change in Body Weight From Baseline to End of 24 Weeks — 1.62; -0.62 kg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Litramine (Dietary_supplement); Placebo (Dietary_supplement)
Age: Adult · 18+ yrs
Sex: All
Sponsor: InQpharm Group
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Body Weight From Baseline to End of 24 Weeks	1.62; -0.62	—
SECONDARY Waist and Hip Circumference (cm)	—	—
SECONDARY Body Mass Index (kg/m^2)	—	—
SECONDARY Full Blood Count	—	—
SECONDARY Blood Pressure	—	—

Summary

The effect of Litramine on weight loss has previously been studied during a 12-week intervention period with promising results. The present study looks into the effect of weight maintenance using Litramine following initial weight loss, for a longer period of 24 weeks.

Eligibility Criteria

Inclusion Criteria

Documented weight loss, achieved over the last 3 to 6 months either from participation in weight loss clinical trials or weight loss regimens, of at least 3% at the point of screening
BMI 25-35 before initial weight loss
Documented compliance (according to the investigator's judgement) to previous weight loss clinical trials/ regimens

Exclusion Criteria

Known sensitivity to the ingredients of the device (citric acid, acacia or Fabaceae family)
BMI < 18.5
Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation

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Data sourced from ClinicalTrials.gov (NCT01505387). 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.