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

Obesity Clinical Trial

Official title:

Double-blind, Randomised, 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058367
• Other study ID #: INQ/023314
• Status: Completed
• Phase: N/A
• First received: February 15, 2017
• Last updated: January 1, 2018
• Start date: May 1, 2017
• Est. completion date: November 28, 2017

Study information

• Verified date: January 2018
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: November 28, 2017
• Est. primary completion date: November 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• IQP-AE-103 (330mg)
High dose capsules
• IQP-AE-103 (165mg)
Low dose capsules
• Placebo
Placebo identical to verum capsules

Locations

Country	Name	City	State
Germany	Analyze & Realize	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety parameters (lab parameters, vital signs)	Change in safety lab parameters, vital signs	12 weeks
Primary	Mean change in body weight (kg)	Difference in mean change of body weight (kg) between the higher dosed verum (1980 mg a day) and placebo group after 12 weeks of intervention in comparison to baseline.	12 weeks
Secondary	Mean change in body weight (kg)	Changes in body weight (kg) after 2, 4, 8, and 12 weeks of intervention, each in comparison to baseline, between the two active and placebo group	2, 4, 8, 12 weeks
Secondary	Mean change in body weight (%)	Changes in body weight (%) after 2, 4, 8, and 12 weeks of intervention, each in comparison to baseline, between the two active and placebo group	2, 4, 8, 12 weeks
Secondary	Proportion of subject weight loss	Proportion of subjects who lost at least 3% and 5% of baseline body weight after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline	2, 4, 8, 12 weeks
Secondary	Change in waist circumference (cm)	Changes in waist circumference after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline	2, 4, 8, 12 weeks
Secondary	Change in hip circumference (cm)	Changes in hip circumference after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline	2, 4, 8, 12 weeks