Benefit and Tolerability of IQP-AE-103 in Weight Loss

NCT ID: NCT03058367

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2017-11-28

Brief Summary

This study is to evaluate the benefit and tolerability of two dosages of IQP-AE-103 (990mg and 1980mg 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-AE-103 (1980mg)

2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks

Group Type: EXPERIMENTAL

IQP-AE-103 (330mg)

Intervention Type: DIETARY_SUPPLEMENT

High dose capsules

Low dose IQP-AE-103 (990mg)

2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks

Group Type: EXPERIMENTAL

IQP-AE-103 (165mg)

Intervention Type: DIETARY_SUPPLEMENT

Low dose capsules

Placebo

2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo identical to verum capsules

Interventions

IQP-AE-103 (330mg)

High dose capsules

Intervention Type: DIETARY_SUPPLEMENT

IQP-AE-103 (165mg)

Low dose capsules

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo identical to verum capsules

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Age 18 to 65 years

2. Overweight to moderately obese subjects (BMI ≥ 25 and < 35 kg/m2)

3. Expressed desire for weight loss

4. Accustomed to 3 main meals/day

5. Commitment to take IP as recommended

6. Commitment to adhere to diet recommendation during the study

7. Commitment to maintain habitual level of activity/exercise during the study

8. Consistent and stable body weight for 3 months prior to V1

9. Commitment to avoid the use of other weight management products or programs during study

10. Commitment and ability to complete the subject diary and study questionnaires

11. Females of childbearing potential: negative pregnancy testing (beta HCG-test in urine) at V1, agreement to use appropriate contraception methods during the study period

12. 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. Pregnancy or nursing

3. 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)

4. Current or history of abuse of drugs, alcohol or medication

5. Clinically relevant excursions of safety laboratory parameter

6. Diabetes mellitus type 1

7. Untreated or unstable diabetes mellitus type 2

8. Untreated or unstable endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders)

9. Stenosis in the gastrointestinal (GI) tract

10. Bariatric surgery in subject´s medical history

11. Abdominal surgery within the last 6 months prior to V1

12. Current use of medications that may affect body weight (eg. antipsychotics, anti-depressants, corticosteroids etc.)

13. Presence of acute or chronic gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease, pancreatitis)

14. Digestion/absorption disorders in gastrointestinal (GI) tract

15. History of eating disorders such as bulimia, anorexia nervosa within the past 12 months prior to V1

16. Other serious organ or systemic diseases such as cancer within the last 5 years prior to V1

17. Any electronic medical implant

18. Use of any medication that could influence GI functions such as antibiotics within 4 weeks and any laxatives, opioids, glucocorticoids, anticholinergics within last 3 months prior to V1 and during the study, as per investigator judgement

19. Any medication or use of products for the treatment of obesity (e.g. orlistat, other fat binder, carbohydrate/starch blocker, fat burner, satiety products etc.) within last 3 months prior to V1 and during the study

20. Participation in similar studies or weight loss programs within last 4 weeks prior to V1

21. Participation in other studies during the last 4 weeks prior to V1

22. Inability to comply

23. Presence of other factor(s) or medication that should preclude subject participation as per investigator judgement

• 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

Locations

Analyze & Realize

Berlin, , Germany

Countries

Germany

References

Peng LV, Cooper J, De Costa P, Chong PW. Microbiota Composition and Diversity in Weight Loss Population After the Intake of IQP-AE-103 in a Double-Blind, Randomized, Placebo-Controlled Study. Front Nutr. 2022 Apr 28;9:790045. doi: 10.3389/fnut.2022.790045. eCollection 2022.

Reference Type: DERIVED

PMID: 35571928 (View on PubMed)

Uebelhack R, Bongartz U, Seibt S, Bothe G, Chong PW, De Costa P, Wszelaki N. Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects. J Obes. 2019 Feb 3;2019:3412952. doi: 10.1155/2019/3412952. eCollection 2019.

Reference Type: DERIVED

PMID: 30863632 (View on PubMed)

Other Identifiers

INQ/023314

Identifier Type: -

Identifier Source: org_study_id