Back to resultsBenefit and Tolerability of IQP-AE-103 in Weight Loss
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
IQP-AE-103 (330mg)
IQP-AE-103 (165mg)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overweight
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 65 years
- Overweight to moderately obese subjects (BMI ≥ 25 and < 35 kg/m2)
- Expressed desire for weight loss
- Accustomed to 3 main meals/day
- Commitment to take IP as recommended
- Commitment to adhere to diet recommendation during the study
- Commitment to maintain habitual level of activity/exercise during the study
- Consistent and stable body weight for 3 months prior to V1
- Commitment to avoid the use of other weight management products or programs during study
- Commitment and ability to complete the subject diary and study questionnaires
- Females of childbearing potential: negative pregnancy testing (beta HCG-test in urine) at V1, agreement to use appropriate contraception methods during the study period
- Consents to participate, understands requirements of the study and is willing to comply
Exclusion Criteria:
- Known sensitivity to the ingredients of the investigational product or source of ingredients
- Pregnancy or nursing
- 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)
- Current or history of abuse of drugs, alcohol or medication
- Clinically relevant excursions of safety laboratory parameter
- Diabetes mellitus type 1
- Untreated or unstable diabetes mellitus type 2
- Untreated or unstable endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders)
- Stenosis in the gastrointestinal (GI) tract
- Bariatric surgery in subject´s medical history
- Abdominal surgery within the last 6 months prior to V1
- Current use of medications that may affect body weight (eg. antipsychotics, anti-depressants, corticosteroids etc.)
- Presence of acute or chronic gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease, pancreatitis)
- Digestion/absorption disorders in gastrointestinal (GI) tract
- History of eating disorders such as bulimia, anorexia nervosa within the past 12 months prior to V1
- Other serious organ or systemic diseases such as cancer within the last 5 years prior to V1
- Any electronic medical implant
- 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
- 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
- Participation in similar studies or weight loss programs within last 4 weeks prior to V1
- Participation in other studies during the last 4 weeks prior to V1
- Inability to comply
- Presence of other factor(s) or medication that should preclude subject participation as per investigator judgement
Sites / Locations
- Analyze & Realize
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
High dose IQP-AE-103 (1980mg)
Low dose IQP-AE-103 (990mg)
Placebo
Arm Description
2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks
2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks
2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
Change in waist circumference (cm)
Changes in waist circumference after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline
Change in hip circumference (cm)
Changes in hip circumference after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03058367
Brief Title
Benefit and Tolerability of IQP-AE-103 in Weight Loss
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
November 28, 2017 (Actual)
Study Completion Date
November 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InQpharm Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High dose IQP-AE-103 (1980mg)
Arm Type
Experimental
Arm Description
2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks
Arm Title
Low dose IQP-AE-103 (990mg)
Arm Type
Experimental
Arm Description
2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
IQP-AE-103 (330mg)
Intervention Description
High dose capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
IQP-AE-103 (165mg)
Intervention Description
Low dose capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo identical to verum capsules
Primary Outcome Measure Information:
Title
Mean change in body weight (kg)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mean change in body weight (kg)
Description
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
Time Frame
2, 4, 8, 12 weeks
Title
Mean change in body weight (%)
Description
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
Time Frame
2, 4, 8, 12 weeks
Title
Proportion of subject weight loss
Description
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
Time Frame
2, 4, 8, 12 weeks
Title
Change in waist circumference (cm)
Description
Changes in waist circumference after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline
Time Frame
2, 4, 8, 12 weeks
Title
Change in hip circumference (cm)
Description
Changes in hip circumference after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline
Time Frame
2, 4, 8, 12 weeks
Other Pre-specified Outcome Measures:
Title
Safety parameters (lab parameters, vital signs)
Description
Change in safety lab parameters, vital signs
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 to 65 years
Overweight to moderately obese subjects (BMI ≥ 25 and < 35 kg/m2)
Expressed desire for weight loss
Accustomed to 3 main meals/day
Commitment to take IP as recommended
Commitment to adhere to diet recommendation during the study
Commitment to maintain habitual level of activity/exercise during the study
Consistent and stable body weight for 3 months prior to V1
Commitment to avoid the use of other weight management products or programs during study
Commitment and ability to complete the subject diary and study questionnaires
Females of childbearing potential: negative pregnancy testing (beta HCG-test in urine) at V1, agreement to use appropriate contraception methods during the study period
Consents to participate, understands requirements of the study and is willing to comply
Exclusion Criteria:
Known sensitivity to the ingredients of the investigational product or source of ingredients
Pregnancy or nursing
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)
Current or history of abuse of drugs, alcohol or medication
Clinically relevant excursions of safety laboratory parameter
Diabetes mellitus type 1
Untreated or unstable diabetes mellitus type 2
Untreated or unstable endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders)
Stenosis in the gastrointestinal (GI) tract
Bariatric surgery in subject´s medical history
Abdominal surgery within the last 6 months prior to V1
Current use of medications that may affect body weight (eg. antipsychotics, anti-depressants, corticosteroids etc.)
Presence of acute or chronic gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease, pancreatitis)
Digestion/absorption disorders in gastrointestinal (GI) tract
History of eating disorders such as bulimia, anorexia nervosa within the past 12 months prior to V1
Other serious organ or systemic diseases such as cancer within the last 5 years prior to V1
Any electronic medical implant
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
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
Participation in similar studies or weight loss programs within last 4 weeks prior to V1
Participation in other studies during the last 4 weeks prior to V1
Inability to comply
Presence of other factor(s) or medication that should preclude subject participation as per investigator judgement
Facility Information:
Facility Name
Analyze & Realize
City
Berlin
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35571928
Citation
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.
Results Reference
derived
PubMed Identifier
30863632
Citation
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.
Results Reference
derived
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Benefit and Tolerability of IQP-AE-103 in Weight Loss
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