Trial Outcomes & Findings for Litramine in Weight Maintenance (NCT NCT01505387)

Results Overview

Change in body weight at the end of 24 weeks measured in kg using a calibrated scale. (positive values signify weight gain, while negative values signify weight reduction

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

24 weeks

Results posted on

2015-06-01

Participant Flow

Trial conducted from January 2012 to September 2012 in two study sites in Germany

Participant milestones

Participant milestones
Measure	Placebo Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal) Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)	Litramine Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal) Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)
Overall Study STARTED	25	25
Overall Study Treated	24	24
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal) Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)	Litramine Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal) Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Litramine in Weight Maintenance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=24 Participants Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal) Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)	Litramine n=25 Participants Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal) Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)	Total n=49 Participants Total of all reporting groups
Age, Continuous	44.1 years STANDARD_DEVIATION 11.2 • n=5 Participants	44.7 years STANDARD_DEVIATION 11.4 • n=7 Participants	44.4 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Body weight (kg)	79.3 kg STANDARD_DEVIATION 9.0 • n=5 Participants	78.2 kg STANDARD_DEVIATION 11.4 • n=7 Participants	78.7 kg STANDARD_DEVIATION 10.2 • n=5 Participants
BMI (kg/m^2)	27.7 kg/m^2 STANDARD_DEVIATION 2.4 • n=5 Participants	27.3 kg/m^2 STANDARD_DEVIATION 2.1 • n=7 Participants	27.5 kg/m^2 STANDARD_DEVIATION 2.2 • n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Change in body weight at the end of 24 weeks measured in kg using a calibrated scale. (positive values signify weight gain, while negative values signify weight reduction

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal) Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)	Litramine n=25 Participants Fibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal) Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)
Mean Change in Body Weight From Baseline to End of 24 Weeks	1.62 kg Standard Deviation 1.48	-0.62 kg Standard Deviation 1.55

SECONDARY outcome

Timeframe: 24 weeks

Changes from baseline to end of study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Changes from baseline to end of study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Measured in mm Hg

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Litramine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Felix Alt

Analyze & Realize

Phone: +49 30 40008100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER