Benefit and Tolerability of IQP-LU-104 in Weight Loss

NCT ID: NCT03888911

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-05
• Study Completion Date: 2019-11-21

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

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

High dose IQP-LU-104 (5120mg)

High dose treatment group

Group Type: EXPERIMENTAL

High dose IQP-LU-104 (5120mg)

Intervention Type: DIETARY_SUPPLEMENT

1 sachet to be taken 2 times daily orally, together with 2 main meals

Low dose IQP-LU-104 (2560mg)

Low dose treatment group

Group Type: EXPERIMENTAL

Low dose IQP-LU-104 (2560mg)

Intervention Type: DIETARY_SUPPLEMENT

1 sachet to be taken 2 times daily orally, together with 2 main meals

Placebo

Placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

1 sachet to be taken 2 times daily orally, together with 2 main meals

Interventions

High dose IQP-LU-104 (5120mg)

1 sachet to be taken 2 times daily orally, together with 2 main meals

Intervention Type: DIETARY_SUPPLEMENT

Low dose IQP-LU-104 (2560mg)

1 sachet to be taken 2 times daily orally, together with 2 main meals

Intervention Type: DIETARY_SUPPLEMENT

Placebo

1 sachet to be taken 2 times daily orally, together with 2 main meals

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InQpharm Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Udo Bongartz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Analyze & Realize

Locations

Analyze & Realize

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 35130547 (View on PubMed)

Other Identifiers

INQ/011618

Identifier Type: -

Identifier Source: org_study_id