DBRPC Study to Evaluate the Efficacy and Safety of IQP-AE-103 in Overweight and Moderately Obese Subjects

NCT04086797 | Completed

• 1 other identifier: PERI/020918
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

The main study objective is to evaluate the efficacy of IQP-AE-103 in reducing body weight in overweight and moderately obese subjects, in the context of an energy restricted diet. Further objectives are to evaluate the beneficial potential of IQP-AE-103 on waist circumference, blood pressure and blood glucose and lipid levels, quality of life, as well as its safety and tolerability

Conditions

Overweight; Obesity

Keywords

IQP-AE-103; overweight treatment; obesity treatment

Outcome Measures

Primary Outcomes (1)

• Difference in body weight

  Difference in body weight (kg) change after 24 weeks of IP intake, in comparison to baseline

  24 weeks

Secondary Outcomes (1)

• Difference in BMI

  24 weeks

Other Outcomes (38)

• Difference in change in waist circumference after 24 weeks weeks of IP intake, in comparison to baseline

  24 weeks

• Difference in body weight (%) change after 24 weeks of IP intake, in comparison to baseline

  24 weeks

• Difference in body weight (kg) change after 16 weeks of IP intake, in comparison to baseline

  16 weeks

Study Arms (2)

IQP-AE-103

EXPERIMENTAL

2 capsules after 3 main meals per day (total 1980 mg)

Dietary Supplement: IQP-AE-103

Placebo

PLACEBO COMPARATOR

2 capsules after 3 main meals per day

Dietary Supplement: Placebo

Interventions

IQP-AE-103 DIETARY_SUPPLEMENT

1980 mg

IQP-AE-103

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women from 18 to 70 years old
• Body mass index (BMI) 25 kg/m2 - 34.9 kg/m2
• Having at least one of the following traits:
• waist circumference ≥ 94 cm in men and ≥ 80 cm in women
• triglyceride levels ≥ 150 mg/dL (1.7 mmol/L)
• high-density lipoprotein cholesterol (HDL-C) levels: ≤ 40 mg/dL (1.0 mmol/L) in men and ≤ 50 mg/dL (1.3 mmol/L) in women
• blood pressure (BP), average value of the last two values of the triplicate measurement: systolic BP ≥ 130 mmHg, diastolic BP ≥ 85 mmHg
• fasting blood glucose ≥ 100 mg/dL
• Desire to lose weight
• Readiness and ability to complete the study, according to investigator's judgement following the screening interview
• Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)
• Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self-reported change)
• Subject's agreement to comply with study procedures, in particular:
• to adhere to diet recommendation during the study
• to take IP as recommended

You may not qualify if:

• Known allergy or hypersensitivity to the components of the investigational product or source plants
• Pathological electrocardiogram (ECG) at V1
• History and/or presence of clinically significant condition/ disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
• untreated or unstable thyroid gland disorder
• hypertension (regular systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
• acute or chronic gastrointestinal (GI) disease or digestion/ absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.)
• diabetes mellitus
• any other relevant serious organ or systemic diseases
• Significant surgery within the last 6 months prior to V1 or planned within the study period:
• GI surgery
• liposuction
• History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 months prior to V1
• 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)
• Any electronic medical implant

Sponsors & Collaborators

• Perrigo CSCI: lead
• Analyze & Realize: collaborator

Study Sites (1)

analyze & realize GmbH

Berlin, 13467, Germany

Location

Related Publications (1)

• 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.

  PMID: 30863632 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ralf Uebelhack, MD

  Analyze & Realize

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: September 11, 2019
• Primary Completion: April 8, 2021
• Study Completion: April 8, 2021
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)