Benefit and Tolerability of IQP-LU-104 in Weight Loss
Double-blind, Randomized, Three-armed, Placebo-controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-LU-104 in Reducing Body Weight in Overweight and Moderately Obese Subjects
1 other identifier
interventional
108
1 country
1
Brief Summary
This study is to evaluate the benefit and tolerability of two dosages of IQP-LU-104 (5120mg and 2560mg daily) in reducing body weight in overweight and moderately obese subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2019
CompletedFirst Submitted
Initial submission to the registry
March 20, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2019
CompletedAugust 3, 2022
August 1, 2022
9 months
March 20, 2019
August 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean change in body weight (kg)
Difference in mean change of body weight (kg) between the higher dosed verum and placebo group after 12 weeks of intervention in comparison to baseline
12 weeks
Mean change in body weight (kg)
Difference in mean change of body weight (kg) between the lower dosed verum and placebo group after 12 weeks of intervention in comparison to baseline
12 weeks
Secondary Outcomes (32)
Mean change in body weight (kg)
4 and 8 weeks
Mean change in body weight (kg)
4 and 8 weeks
Body weight (kg)
4, 8, 12 weeks
Change in body weight percentage (%)
4, 8, 12 weeks
Proportion of subjects with weight loss
4, 8, 12 weeks
- +27 more secondary outcomes
Other Outcomes (1)
Safety parameters (lab parameters and vital signs)
12 weeks
Study Arms (3)
High dose IQP-LU-104 (5120mg)
EXPERIMENTALHigh dose treatment group
Low dose IQP-LU-104 (2560mg)
EXPERIMENTALLow dose treatment group
Placebo
PLACEBO COMPARATORPlacebo group
Interventions
1 sachet to be taken 2 times daily orally, together with 2 main meals
1 sachet to be taken 2 times daily orally, together with 2 main meals
1 sachet to be taken 2 times daily orally, together with 2 main meals
Eligibility Criteria
You may qualify if:
- Age 18 to 65 years
- Overweight (BMI 25 to \< 30 kg/m2) and moderately obese (BMI 30 to \< 35 kg/m2) subjects
- Generally in good health
- Desire to lose weight
- 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 follow diet recommendation during the study
- to complete the subject diary and study questionnaires
- to maintain the habitual level of physical activity during the study
- Women of childbearing potential:
- commitment to use contraception methods
- negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- Consents to participate, understands requirements of the study and is willing to comply
You may not qualify if:
- Known sensitivity to the ingredients of the investigational product or source of ingredients
- History and/or presence of clinically significant condition/disorder, which per investigator's judgment could interfere with the results of the study or the safety of the subject, e.g.:
- untreated or non-stabilised thyroid gland disorder
- untreated or non-stabilised hypertension (regular systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
- 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 non-stabilised diabetes mellitus type 2
- any other relevant serious organ or systemic diseases
- 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:
- clinically significant or
- \> 2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InQpharm Grouplead
Study Sites (1)
Analyze & Realize
Berlin, 10369, Germany
Related Publications (1)
Bongartz U, Hochmann U, Grube B, Uebelhack R, Alt F, Erlenbeck C, Peng LV, Chong PW, De Costa P. Flaxseed Mucilage (IQP-LU-104) Reduces Body Weight in Overweight and Moderately Obese Individuals in a 12-week, Three-Arm, Double-Blind, Randomized, and Placebo-Controlled Clinical Study. Obes Facts. 2022;15(3):395-404. doi: 10.1159/000522082. Epub 2022 Feb 7.
PMID: 35130547DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Udo Bongartz, MD, PhD
Analyze & Realize
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
March 20, 2019
First Posted
March 25, 2019
Study Start
March 5, 2019
Primary Completion
November 21, 2019
Study Completion
November 21, 2019
Last Updated
August 3, 2022
Record last verified: 2022-08