OverweightNCT03888911
Benefit and Tolerability of IQP-LU-104 in Weight Loss
A study testing High dose IQP-LU-104 (5120mg) and Low dose IQP-LU-104 (2560mg) in people with Overweight and Obesity, run by InQpharm Group at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- High dose IQP-LU-104 (5120mg) and Low dose IQP-LU-104 (2560mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- 5 Mar 2019to 21 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 15Show fewer
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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)
- Any electronic medical implant
- Regular medication and/or supplementation and/or treatment within the last month prior to V1 and during the study, which per investigator's judgment could interfere with the results of the study or the safety of the subject, e.g.:
- that could influence body weight (e.g. systemic cortcosteroids, antipsychotics, anti-depressants)
- that could influence gastrointestinal functions (e.g. antibiotics, laxatives, opioids, anticholinergics etc.) as per investigator judgment
- for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner, satiety products etc.)
- any other relevant medication and/or supplementation
- Diet/weight loss programs within the last 3 months prior to V1 and during the study
- Smoking cessation within 6 months prior to V1 or during the study (regular smoking during the study at the same level as prior to the study is allowed)
- Vegetarian, vegan or other restrictive diet
- Women of child-bearing potential: pregnancy or nursing
- History of or current abuse of drugs, alcohol or medication
- Participation in another clinical study in the 30 days prior to V1 and during the study
- Any other reason for exclusion as per investigator's judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Overweight, Obesity
- Being tested
- High dose IQP-LU-104 (5120mg), Low dose IQP-LU-104 (2560mg), Placebo
- Keywords
- Flaxseed mucilage, Weight loss, Satiety
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose IQP-LU-104 (5120mg)Dietary supplement
1 sachet to be taken 2 times daily orally, together with 2 main meals
Low dose IQP-LU-104 (2560mg)Dietary supplement
1 sachet to be taken 2 times daily orally, together with 2 main meals
PlaceboDietary supplement
1 sachet to be taken 2 times daily orally, together with 2 main meals
| Study group | Role | What they receive |
|---|---|---|
| High dose IQP-LU-104 (5120mg) | Experimental | High dose treatment group Receives: Dietary Supplement: High dose IQP-LU-104 (5120mg) |
| Low dose IQP-LU-104 (2560mg) | Experimental | Low dose treatment group Receives: Dietary Supplement: Low dose IQP-LU-104 (2560mg) |
| Placebo | Placebo comparator | Placebo group Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 weeks
Secondary outcomes (32)
Mean change in body weight (kg)
Difference between the higher dosed verum and placebo group in mean change of body weight (kg) after 4 and 8 weeks of intervention, each in comparison to baseline
Measured: 4 and 8 weeks
Mean change in body weight (kg)
Difference between the lower dosed verum and placebo group in mean change of body weight (kg) after 4 and 8 weeks of intervention, each in comparison to baseline
Measured: 4 and 8 weeks
Body weight (kg)
Difference between the two verum and placebo groups in body weight (kg) after 4, 8, and 12 weeks of intervention
Measured: 4, 8, 12 weeks
Change in body weight percentage (%)
Difference between the two verum and placebo groups in the changes in body weight (%) after 4, 8, and 12 weeks of intervention, each in comparison to baseline
Measured: 4, 8, 12 weeks
Proportion of subjects with weight loss
Difference between the two verum and placebo groups in the proportion of subjects who lost at least 3%, 5% and 10% of baseline body weight after 4, 8, and 12 weeks of intervention, each in comparison to baseline
Measured: 4, 8, 12 weeks
Waist circumference (cm)
Difference between the two verum and placebo groups in waist circumference (cm) after 4, 8, and 12 weeks of intervention
Measured: 4, 8, 12 weeks
Change in waist circumference (cm)
Difference between the two verum and placebo groups in the changes in waist circumference (cm) after 4, 8, and 12 weeks of intervention, each in comparison to baseline
Measured: 4, 8, 12 weeks
Hip circumference (cm)
Difference between the two verum and placebo groups in hip circumference (cm) after 4, 8, and 12 weeks of intervention
Measured: 4, 8, 12 weeks
Change in hip circumference (cm)
Difference between the two verum and placebo groups in the changes in hip circumference (cm) after 4, 8, and 12 weeks of intervention, each in comparison to baseline
Measured: 4, 8, 12 weeks
Waist-hip ratio
Difference between the two verum and placebo groups in waist-hip ratio after 4, 8, and 12 weeks of intervention
Measured: 4, 8, 12 weeks
Change in waist-hip ratio
Difference between the two verum and placebo groups in the changes in waist-hip ratio after 4, 8, and 12 weeks of intervention, each in comparison to baseline
Measured: 4, 8, 12 weeks
BMI (kg/m^2)
Difference between the two verum and placebo groups in BMI (kg/m^2) after 4, 8, and 12 weeks of intervention
Measured: 4, 8, 12 weeks
Change in BMI (kg/m^2)
Difference between the two verum and placebo group in the changes in BMI (kg/m^2) after 4, 8, and 12 weeks of intervention, each in comparison to baseline
Measured: 4, 8, 12 weeks
Body fat percentage (%)
Difference between the two verum and placebo groups in body fat (%) after 4, 8, and 12 weeks of intervention
Measured: 4, 8, 12 weeks
Change in body fat percentage (%)
Difference between the two verum and placebo groups in the changes in body fat (%) after 4, 8, and 12 weeks of intervention, each in comparison to baseline
Measured: 4, 8, 12 weeks
Body fat mass (kg)
Difference between the two verum and placebo groups in body fat mass (kg) after 4, 8, and 12 weeks of intervention
Measured: 4, 8, 12 weeks
Change in body fat mass (kg)
Difference between the two verum and placebo groups in the changes in body fat mass (kg) after 4, 8, and 12 weeks of intervention, each in comparison to baseline
Measured: 4, 8, 12 weeks
Fat free mass (kg)
Difference between the two verum and placebo groups in fat free mass (kg) after 4, 8, and 12 weeks of intervention
Measured: 4, 8, 12 weeks
Change in fat free mass (kg)
Difference between the two verum and placebo groups in the changes in fat free mass (kg) after 4, 8, and 12 weeks of intervention, each in comparison to baseline
Measured: 4, 8, 12 weeks
Evaluation of feeling of hunger using visual analogue scales (VAS)
Difference between the two verum and placebo groups in the evaluation of feelings of hunger using VAS after 4, 8, and 12 weeks of intervention
Measured: 4, 8, 12 weeks
Change in the evaluation of feeling of hunger using visual analogue scales (VAS)
Difference between the two verum and placebo groups in the changes in evaluation of feelings of hunger using VAS after 4, 8, and 12 weeks of intervention, each in comparison to baseline
Measured: 4, 8, 12 weeks
Evaluation of feeling of satiety using visual analogue scales (VAS)
Difference between the two verum and placebo groups in the evaluation of feelings of satiety using VAS after 4, 8, and 12 weeks of intervention
Measured: 4, 8, 12 weeks
Change in the evaluation of feeling of satiety using visual analogue scales (VAS)
Difference between the two verum and placebo groups in the changes in evaluation of feelings of satiety using VAS after 4, 8, and 12 weeks of intervention, each in comparison to baseline
Measured: 4, 8, 12 weeks
Evaluation of feeling of fullness using visual analogue scales (VAS)
Difference between the two verum and placebo groups in the evaluation of feelings of fullness using VAS after 4, 8, and 12 weeks of intervention
Measured: 4, 8, 12 weeks
Change in the evaluation of feeling of fullness using visual analogue scales (VAS)
Difference between the two verum and placebo groups in the changes in evaluation of feelings of fullness using VAS after 4, 8, and 12 weeks of intervention, each in comparison to baseline
Measured: 4, 8, 12 weeks
Evaluation of feeling of craving using visual analogue scales (VAS)
Difference between the two verum and placebo groups in the evaluation of feelings of craving using VAS after 4, 8, and 12 weeks of intervention
Measured: 4, 8, 12 weeks
Change in the evaluation of feeling of craving using visual analogue scales (VAS)
Difference between the two verum and placebo groups in the changes in evaluation of feelings of craving using VAS after 4, 8, and 12 weeks of intervention, each in comparison to baseline
Measured: 4, 8, 12 weeks
Change in the quality of life using Impact of Weight on Quality of Life (IWQOL-Lite) Questionnaire
Difference between the two verum and placebo groups in the changes in quality of life using (IWQOL-Lite) questionnaire after 4, 8 and 12 weeks of intervention, each in comparison to baseline
Measured: 4, 8, 12 weeks
Lipid metabolism parameters (mmol/l)
Difference between the two verum and placebo groups in total cholesterol (mmol/l), LDL-cholesterol (mmol) and HDL cholesterol (mmol) after 12 weeks of intervention
Measured: 12 weeks
Change in lipid metabolism parameters (mmol/l)
Difference between the two verum and placebo groups in the changes in lipid metabolism parameters after 12 weeks of intervention, each in comparison to baseline
Measured: 12 weeks
HbA1C percentage (%)
Difference between the two verum and placebo groups in HbA1C (%) after 12 weeks of intervention
Measured: 12 weeks
Change in HbA1C percentage (%)
Difference between the two verum and placebo groups in the changes in HbA1C (%) after 12 weeks of intervention, each in comparison to baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start5 Mar 2019
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Udo Bongartz, MD, PhD, Principal investigator, Analyze & Realize
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888911
- Sponsor's protocol ID
- INQ/011618
- Status last verified
- Aug 2022
- First submitted
- 20 Mar 2019
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35130547
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03888911
- Acronym / sponsor ID
- INQ/011618
- Conditions
- Overweight, Obesity
- Keywords
- Flaxseed mucilage, Weight loss, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose IQP-LU-104 (5120mg) | Experimental | Dietary Supplement: High dose IQP-LU-104 (5120mg)High dose treatment group |
| Low dose IQP-LU-104 (2560mg) | Experimental | Dietary Supplement: Low dose IQP-LU-104 (2560mg)Low dose treatment group |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (28 listed)
- 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.:
- Significant surgery within the last 6 months prior to V1:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose IQP-LU-104 (5120mg)1 sachet to be taken 2 times daily orally, together with 2 main meals | Dietary supplement | High dose IQP-LU-104 (5120mg) |
| Low dose IQP-LU-104 (2560mg)1 sachet to be taken 2 times daily orally, together with 2 main meals | Dietary supplement | Low dose IQP-LU-104 (2560mg) |
| Placebo1 sachet to be taken 2 times daily orally, together with 2 main meals | Dietary supplement | Placebo |
Primary outcome
Mean change in body weight (kg)
Time frame: 12 weeks
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
Mean change in body weight (kg)
Time frame: 12 weeks
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
32 secondary outcomes
Mean change in body weight (kg)
Time frame: 4 and 8 weeks
Mean change in body weight (kg)
Time frame: 4 and 8 weeks
Body weight (kg)
Time frame: 4, 8, 12 weeks
Change in body weight percentage (%)
Time frame: 4, 8, 12 weeks
Proportion of subjects with weight loss
Time frame: 4, 8, 12 weeks
Waist circumference (cm)
Time frame: 4, 8, 12 weeks
Change in waist circumference (cm)
Time frame: 4, 8, 12 weeks
Hip circumference (cm)
Time frame: 4, 8, 12 weeks
Change in hip circumference (cm)
Time frame: 4, 8, 12 weeks
Waist-hip ratio
Time frame: 4, 8, 12 weeks
Change in waist-hip ratio
Time frame: 4, 8, 12 weeks
BMI (kg/m^2)
Time frame: 4, 8, 12 weeks
Change in BMI (kg/m^2)
Time frame: 4, 8, 12 weeks
Body fat percentage (%)
Time frame: 4, 8, 12 weeks
Change in body fat percentage (%)
Time frame: 4, 8, 12 weeks
Body fat mass (kg)
Time frame: 4, 8, 12 weeks
Change in body fat mass (kg)
Time frame: 4, 8, 12 weeks
Fat free mass (kg)
Time frame: 4, 8, 12 weeks
Change in fat free mass (kg)
Time frame: 4, 8, 12 weeks
Evaluation of feeling of hunger using visual analogue scales (VAS)
Time frame: 4, 8, 12 weeks
Change in the evaluation of feeling of hunger using visual analogue scales (VAS)
Time frame: 4, 8, 12 weeks
Evaluation of feeling of satiety using visual analogue scales (VAS)
Time frame: 4, 8, 12 weeks
Change in the evaluation of feeling of satiety using visual analogue scales (VAS)
Time frame: 4, 8, 12 weeks
Evaluation of feeling of fullness using visual analogue scales (VAS)
Time frame: 4, 8, 12 weeks
Change in the evaluation of feeling of fullness using visual analogue scales (VAS)
Time frame: 4, 8, 12 weeks
Evaluation of feeling of craving using visual analogue scales (VAS)
Time frame: 4, 8, 12 weeks
Change in the evaluation of feeling of craving using visual analogue scales (VAS)
Time frame: 4, 8, 12 weeks
Change in the quality of life using Impact of Weight on Quality of Life (IWQOL-Lite) Questionnaire
Time frame: 4, 8, 12 weeks
Lipid metabolism parameters (mmol/l)
Time frame: 12 weeks
Change in lipid metabolism parameters (mmol/l)
Time frame: 12 weeks
HbA1C percentage (%)
Time frame: 12 weeks
Change in HbA1C percentage (%)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Derived from this study: PubMed 35130547Bongartz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Udo Bongartz, MD, PhD principal investigator
Analyze & Realize
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose IQP-LU-104 (5120mg) and Low dose IQP-LU-104 (2560mg) in people with Overweight and Obesity, run by InQpharm Group at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in body weight (kg) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03888911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.