Litramine in Weight Maintenance

InQpharm

Status and phase: Completed; Phase 4

Conditions: Obese; Overweight; Weight Maintenance

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Litramine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01505387

INQ/024511

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)

Treatment:

Dietary Supplement: Placebo

Litramine

Experimental group

Description:

Fibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal)

Treatment:

Dietary Supplement: Litramine