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

NCT03058367 | Completed

• 1 other identifier: INQ/023314
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mean change in body weight (kg)

  2, 4, 8, 12 weeks

• Mean change in body weight (%)

  2, 4, 8, 12 weeks

• Proportion of subject weight loss

  2, 4, 8, 12 weeks

• Change in waist circumference (cm)

  2, 4, 8, 12 weeks

• Change in hip circumference (cm)

  2, 4, 8, 12 weeks

Other Outcomes (1)

• Safety parameters (lab parameters, vital signs)

  12 weeks

Study Arms (3)

High dose IQP-AE-103 (1980mg)

EXPERIMENTAL

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

Dietary Supplement: IQP-AE-103 (330mg)

Low dose IQP-AE-103 (990mg)

EXPERIMENTAL

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

Dietary Supplement: IQP-AE-103 (165mg)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

IQP-AE-103 (330mg) DIETARY_SUPPLEMENT

High dose capsules

High dose IQP-AE-103 (1980mg)

IQP-AE-103 (165mg) DIETARY_SUPPLEMENT

Low dose capsules

Low dose IQP-AE-103 (990mg)

Placebo DIETARY_SUPPLEMENT

Placebo identical to verum capsules

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InQpharm Group: lead

Study Sites (1)

Analyze & Realize

Berlin, Germany

Location

Related Publications (2)

• 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.

  PMID: 35571928 DERIVED

• 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 DERIVED

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 Design

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

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: May 1, 2017
• Primary Completion: November 28, 2017
• Study Completion: November 28, 2017
• Last Updated: January 3, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)