Efficacy and Safety of IQP-AK-102 in Reducing Appetite

NCT ID: NCT02774486

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2016-07-20

Brief Summary

The primary cause of being overweight is an imbalance in calories consumed and energy expenditure. A surplus in energy intake might result in body fat deposition and thereby body weight gain. Therefore, food intake regulation is crucial to control the body weight gain.

Appetite regulation plays an important role in determining the food intake, which is a complex process influenced by the individual (physiology and psychology) and environment. Satiation (process that leads to the termination of eating) and satiety (decline in hunger, increase in fullness after a meal has finished) are the precursors of appetite regulation, which may be induced by various food components such as macronutrients, water, alcohol and non-digestible polysaccharides. High viscosity and swellable/bulking food components such as dietary fibre are expected to elicit stronger satiation/satiety than the macronutrients or clear liquid. Due to its unique physicochemical properties, dietary fibre has been recognized as potential ingredient that helps to enhance the sensation of satiety in the upper gut by increasing gastric distension and delaying gastric emptying, which subsequently reduces the food intake.

IQP-AK-102 comprises of a proprietary blend of dietary fibres known to promote a feeling a fullness. The objectives of this study are to evaluate the efficacy and safety of IQP-AK-102 on appetite reduction in overweight subjects during a 4-weeks interval.

Conditions

Appetite Regulation; Appetite Suppression; Energy Intake

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IQP-AK-102

2 capsules to be taken 3 times daily orally, 30 min before each main meal (breakfast, lunch, dinner) with 250 mL of water

Group Type: EXPERIMENTAL

IQP-AK-102

Intervention Type: DEVICE

IQP-AK-102 has been qualified as a medical device (CE certificate has been ob- tained), class IIb, according to MDD 93/42/EEC, annex IX, rule 5.

Interventions

IQP-AK-102

IQP-AK-102 has been qualified as a medical device (CE certificate has been ob- tained), class IIb, according to MDD 93/42/EEC, annex IX, rule 5.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Males and females, aged 18-65 years

2. BMI ≥25 and BMI <30 kg/m2

3. Generally in good health

4. Regular daily consumption of 3 main meals (breakfast, lunch, dinner)

5. Consistent regular physical activity (≤4 hours of strenuous sportive activity per week) AND willingness to maintain the same level of sport activity throughout the study

6. Commitment to avoid the use of other weight loss and/or management products / programmes during the study

7. Commitment to complete the subject diary correctly and to adhere to the lifestyle recommended for this study

8. Stable concomitant medications (if any)

9. Stable body weight for the last 3 months prior to V1 (less than 5% self-reported change)

10. Subject's agreement to comply with study procedures

11. Negative pregnancy testing (beta HCG-test in urine) at V1 in females of childbearing potential

12. Women of child-bearing potential: willingness to use reliable method of contraception during the study period

Exclusion Criteria

1. Known sensitivity to the components of the investigational product

2. Bariatric surgery in the last 12 months prior to V1

3. Abdominal surgery within the last 6 months prior to V1

4. Presence of any active gastrointestinal disease incl. stenosis in the gastrointestinal tract

5. Malabsorption disorders

6. Pancreatitis

7. History of eating disorders like bulimia, anorexia nervosa, binge-eating (within the last 12 months prior to V1)

8. Lack of appetite for any (unknown) reason

9. Use of medications that could influence gastrointestinal functions such as antibiotics, laxatives, opioids, anticholinergics, anti-diarrheals 3 months prior to V1 and during the study

10. Use of medications that could influence body weight (e.g. antidepressants) in the last 3 months prior to V1 and during the study

11. Any medication or use of products for the treatment of obesity (e.g. fat binder, fat burner, satiety products etc.) or treatment that could influence food absorption, in last 3 months before V1 and during the study

12. Gluten allergy

13. History of abuse of drugs, alcohol or medication

14. Exceeding moderate alcohol consumption (≥21 units /week; 1 unit is equal 1⁄2 l of beer, or 200 ml of wine, or 50 ml hard liquor)

16. Inability to comply with study procedures (e.g. due to language difficulties etc.)

17. Participation in similar studies or weight loss programs within the last 6 months prior to V1 and during the study

18. Participation in other clinical studies within the last 30 days prior to V1 and during the study

19. Clinically relevant deviations of laboratory values

20. Any other reason deemed suitable for exclusion, per investigator's judgement

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InQpharm Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralf Uebelhack, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

analyze & realize GmbH

Locations

Barbara Grube

Berlin, , Germany

Countries

Germany

Other Identifiers

INQ/025115

Identifier Type: -

Identifier Source: org_study_id