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

NCT02774486 | Completed

• 1 other identifier: INQ/025115
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Changes in appetite before and after breakfast 3 days a week (including one weekend day) using Haber Score (hunger, satiety)

  \- Comparison between week 2 and week 3 (first week of the IP intake) as well as comparison between week 2 and week 6 (last week of the IP intake)

  6 weeks

• Changes in appetite before and after breakfast 3 days a week (including one weekend day) using VAS (hunger, satiety, fullness, prospective food consumption).

  \- Comparison between week 2 and week 3 (first week of the IP intake) as well as comparison between week 2 and week 6 (last week of the IP intake)

  6 weeks

Secondary Outcomes (13)

• Changes in food intake using the subject diary

  6 weeks

• Changes in body weight using calibrated weighing scales (Tanita BC-420 SMA)

  6 weeks

• Changes in BMI

  6 weeks

• Changes in waist circumference

  6 weeks

• Changes in hip circumference

  6 weeks

Study Arms (1)

IQP-AK-102

EXPERIMENTAL

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

Device: IQP-AK-102

Interventions

IQP-AK-102 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.

IQP-AK-102

Eligibility Criteria

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

You may qualify if:

• Males and females, aged 18-65 years
• BMI ≥25 and BMI \<30 kg/m2
• Generally in good health
• Regular daily consumption of 3 main meals (breakfast, lunch, dinner)
• 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
• Commitment to avoid the use of other weight loss and/or management products / programmes during the study
• Commitment to complete the subject diary correctly and to adhere to the lifestyle recommended for this study
• Stable concomitant medications (if any)
• Stable body weight for the last 3 months prior to V1 (less than 5% self-reported change)
• Subject's agreement to comply with study procedures
• Negative pregnancy testing (beta HCG-test in urine) at V1 in females of childbearing potential
• Women of child-bearing potential: willingness to use reliable method of contraception during the study period

You may not qualify if:

• Known sensitivity to the components of the investigational product
• Bariatric surgery in the last 12 months prior to V1
• Abdominal surgery within the last 6 months prior to V1
• Presence of any active gastrointestinal disease incl. stenosis in the gastrointestinal tract
• Malabsorption disorders
• Pancreatitis
• History of eating disorders like bulimia, anorexia nervosa, binge-eating (within the last 12 months prior to V1)
• Lack of appetite for any (unknown) reason
• 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
• Use of medications that could influence body weight (e.g. antidepressants) in the last 3 months prior to V1 and during the study
• 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
• Gluten allergy
• History of abuse of drugs, alcohol or medication
• 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)
• Inability to comply with study procedures (e.g. due to language difficulties etc.)

Sponsors & Collaborators

• InQpharm Group: lead

Study Sites (1)

Barbara Grube

Berlin, 10709, Germany

Location

Study Officials

• Ralf Uebelhack, MD, PhD

  analyze & realize GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: May 17, 2016
• Study Start: May 1, 2016
• Primary Completion: July 20, 2016
• Study Completion: July 20, 2016
• Last Updated: January 3, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)