NCT03227276

Brief Summary

To evaluate the efficacy of Litramine in reducing body weight in the context of an energy-restricted diet in overweight and moderately obese subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

August 14, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

2.5 years

First QC Date

July 19, 2017

Last Update Submit

February 27, 2020

Conditions

Obesity; Excess CaloriesOverweight and ObesityWeight Loss

Keywords

LitramineOpuntia ficus-indicaweight loss

Outcome Measures

Primary Outcomes (1)

  • Difference in mean body weight (kg) of overweight subjects

    Difference in mean body weight (kg) of overweight subjects after 52 weeks of IP intake in comparison between verum and placebo

    52 weeks

Secondary Outcomes (3)

  • Difference in mean body weight (kg) of all subjects

    52 weeks

  • Difference in mean body weight (kg) of obese subjects

    52 weeks

  • Proportion of subjects who lost at least 3%, 5% and 10% of baseline body weight

    52 weeks

Other Outcomes (2)

  • Adverse effects

    52 weeks

  • Safety parameters (Lab parameters, vital signs)

    52 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo tablet

Litramine

EXPERIMENTAL
Dietary Supplement: Litramine

Interventions

LitramineDIETARY_SUPPLEMENT

2 tablets to be taken 3 times a day after meals

Litramine
Placebo tabletDIETARY_SUPPLEMENT

2 tablets to be taken 3 times a day after meals

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women from 18 to 70 years old
  • Overweight (BMI 25 kg/m2 - 29.9 kg/m2) for 80% of randomized subjects and obese (BMI 30 kg/m2 - 34.9 kg/m2) for 20% of randomized subjects
  • Generally in good health
  • Desire to lose weight
  • Readiness and ability to complete the 1-year study, according to investigator's judgement following the screening interview
  • Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)
  • Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self- reported change)
  • Subject's agreement to comply with study procedures, in particular:
  • to take IP as recommended
  • to avoid the use of other weight loss and/or management products and/or programs during the study
  • to adhere to diet recommendation during the study
  • to complete the subject diary and study questionnaires
  • Women of childbearing potential:
  • commitment to use contraception methods
  • negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
  • +1 more criteria

You may not qualify if:

  • Known allergy or hypersensitivity to the components of the investigational products or source plants
  • Pathological electrocardiogram (ECG) at V1
  • History and/or presence of clinically significant condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
  • untreated or unstable thyroid gland disorder
  • untreated or unstable hypertension (regular blood pressure \>140/90 mm Hg)
  • acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders (e.g.
  • inflammatory bowel disease, coeliac disease, pancreatitis etc.)
  • diabetes mellitus type 1
  • untreated or unstable diabetes mellitus type 2
  • any other serious organ or systemic diseases that could influence the conduct and/or outcome of the study and/or could affect the tolerability of the subject
  • Significant surgery within the last 6 months prior to V1:
  • GI surgery
  • liposuction
  • History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 months prior to V1
  • Deviation of safety laboratory parameter(s) at V1 that is:
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Analyze & Realize

Berlin, 10369, Germany

Location

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Udo Bongartz, MD

    Analyze & Realize

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 24, 2017

Study Start

August 14, 2017

Primary Completion

February 19, 2020

Study Completion

February 19, 2020

Last Updated

February 28, 2020

Record last verified: 2020-02

Locations

DE(1)