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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Dietary supplement: IQP-AE-103 (330mg); Dietary supplement: IQP-AE-103 (165mg); Dietary supplement: Placebo

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

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • 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 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

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
EXPERIMENTAL: High dose IQP-AE-103 (1980mg); 2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks	Dietary supplement: IQP-AE-103 (330mg); High dose capsules
EXPERIMENTAL: Low dose IQP-AE-103 (990mg); 2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks	Dietary supplement: IQP-AE-103 (165mg); Low dose capsules
PLACEBO_COMPARATOR: Placebo; 2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks	Dietary supplement: Placebo; Placebo identical to verum capsules

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 (1980 mg a day) 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)	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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety parameters (lab parameters, vital signs)	Change in safety lab parameters, vital signs	12 weeks

Collaborators and Investigators

• Sponsor: InQpharm Group

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: J Obes. 2019 Jul 11;2019:6189724.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): November 28, 2017
• Study Completion (ACTUAL): November 28, 2017

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (ACTUAL): February 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 1, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: INQ/023314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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