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

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 Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Dietary supplement: High dose IQP-LU-104 (5120mg); Dietary supplement: Low dose IQP-LU-104 (2560mg); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10369
    • Analyze & Realize

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 to 65 years
2. Overweight (BMI 25 to < 30 kg/m2) and moderately obese (BMI 30 to < 35 kg/m2) subjects
3. Generally in good health
4. Desire to lose weight
5. Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)
6. Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self-reported change)

7. 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

8. Women of childbearing potential:

   • commitment to use contraception methods
   • negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
9. Consents to participate, understands requirements of the study and is willing to comply

Exclusion Criteria:

1. Known sensitivity to the ingredients of the investigational product or source of ingredients

2. 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

3. Significant surgery within the last 6 months prior to V1:

   • GI surgery
   • liposuction
4. History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 months prior to V1

5. 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)
6. Any electronic medical implant

7. 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
8. Diet/weight loss programs within the last 3 months prior to V1 and during the study
9. 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)
10. Vegetarian, vegan or other restrictive diet
11. Women of child-bearing potential: pregnancy or nursing
12. History of or current abuse of drugs, alcohol or medication
13. Participation in another clinical study in the 30 days prior to V1 and during the study
14. Any other reason for exclusion as per investigator's judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo group	Dietary supplement: Placebo; 1 sachet to be taken 2 times daily orally, together with 2 main meals
Experimental: High dose IQP-LU-104 (5120mg); High dose treatment group	Dietary supplement: High dose IQP-LU-104 (5120mg); 1 sachet to be taken 2 times daily orally, together with 2 main meals
Experimental: Low dose IQP-LU-104 (2560mg); Low dose treatment group	Dietary supplement: Low dose IQP-LU-104 (2560mg); 1 sachet to be taken 2 times daily orally, together with 2 main meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	12 weeks
HbA1C percentage (%)	Difference between the two verum and placebo groups in HbA1C (%) after 12 weeks of intervention	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	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety parameters (lab parameters and vital signs)	Assessment of laboratory results in full blood count, clinical chemistry, blood pressure and pulse rate	12 weeks

Collaborators and Investigators

• Sponsor: InQpharm Group
• Investigators: Principal Investigator: Udo Bongartz, MD, PhD, Analyze & Realize

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2019
• Primary Completion (Actual): November 21, 2019
• Study Completion (Actual): November 21, 2019

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Weight loss; Satiety; Flaxseed mucilage
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: INQ/011618

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No