Skip to main content
OpenTrials
Completed

NCT Number: NCT02041754

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

The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several studies demonstrating their efficacy, we are conducting this study to look into the efficacy and safety of this novel combination of three fibres, in appetite regulation, aiming to reduce the appetite.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Weight Loss Appetite Modulation (Focus of Study) Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Udo Bongartz

Berlin, State of Berlin, 10369, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 65 years
  • 25≤BMI≤35
  • Expressed desire for weight loss
  • Accustomed to 3 main meals/day
  • Generally in good health
  • Consistent and stable body weight 3 months prior to study enrolment
  • Consistent regular physical activity
  • Commitment to avoid the use of other weight loss products during study
  • Commitment to adhere to diet and lifestyle recommended for the study

Exclusion criteria

  • Known sensitivity to the ingredients of the device
  • Presence of any active gastrointestinal disease
  • Malabsorption disorders
  • Pancreatitis
  • Stenosis in the GI tract
  • Bariatric surgery
  • Any other reason deemed suitable for exclusion, per investigator's judgement

Treatment and study plan

IQP-AK-102

Device

PLACEBO

Device

Primary outcomes

  1. Difference of VAS between two study arms measured from time '0 to '240 during baseline visit and the final visit

    Time frame: 4 weeks

    Measured using a visual analogue scale (VAS)

Secondary outcomes

  1. Difference in ad libitum energy intake between the two arms at baseline visit and at final visit

    Time frame: 4 weeks

    Measured in kcal

  2. Change in "difference in ad libitum energy intake between two study arms", from baseline visit to the final visit

    Time frame: 4 weeks

    Measured in kcal

  3. Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms

    Time frame: 4 weeks

    Measured using VAS

  4. Difference in the mean change in body weight between the 2 arms, from baseline to the final visit

    Time frame: 4 weeks

    Measured in kg. Subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA)

  5. Changes in waist and hip circumference

    Time frame: 4 weeks

    Measured in cm. Waist: measured at the level midway between the lateral lower rib margin and the iliac crest Hip: measured as the maximal circumference over the buttocks

  6. Changes in body fat content and fat free mass

    Time frame: 4 weeks

    Measured in % and kg using bio-impedence method using validated electronic weighing scales (Tanita BC-420 SMA)

  7. Subjects global feeling of satiety

    Time frame: 4 weeks

  8. Food Craving Questionnaire

    Time frame: 4 weeks

    15 questions

  9. Global evaluation of efficacy by the subjects and investigators

    Time frame: 4 weeks

  10. Global evaluation of safety by the subjects and investigators

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

InQpharm Group

Industry

Registry information

Official study title

Double Blind, Randomized, Placebo-controlled, Monocentric Clinical Investigation to Evaluate Efficacy of IQP-AK-102 on Appetite Reduction in Healthy Overweight and Obese Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 22, 2014
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.