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Appetite RegulationNCT02774486

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

A study testing IQP-AK-102 in people with Appetite Regulation and Appetite Suppression, run by InQpharm Group at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
IQP-AK-102
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteGermany
Study dates
1 May 2016to 20 Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)
  • Smoking cessation within 6 months prior to V1 or during the study (regular smoking at the same level as prior to the study during the study is not an exclusion criteria)
  • Inability to comply with study procedures (e.g. due to language difficulties etc.)
  • Participation in similar studies or weight loss programs within the last 6 months prior to V1 and during the study
  • Participation in other clinical studies within the last 30 days prior to V1 and during the study
  • Clinically relevant deviations of laboratory values
  • Any other reason deemed suitable for exclusion, per investigator's judgement

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Barbara Grube

    Berlin, 10709

Other trials in Germany

About this study

Official title: Open-Label Clinical Investigation to Evaluate Efficacy and Safety of IQP-AK-102 on Appetite Reduction in Healthy Over- Weight Subjects

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.

Being tested
IQP-AK-102

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IQP-AK-102Device

    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.

Study groups in NCT02774486
Study groupRoleWhat they receive
IQP-AK-102Experimental2 capsules to be taken 3 times daily orally, 30 min before each main meal (breakfast, lunch, dinner) with 250 mL of water
Receives: Device: IQP-AK-102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 6 weeks

  2. 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)

    Measured: 6 weeks

Secondary outcomes (13)

  1. Changes in food intake using the subject diary

    Measured on the same days as appetite assessment (for breakfast, lunch, dinner, in between meal/snacks), during the run-in phase (three days a week, both weeks) and treatment phase (at first week of the IP intake (week 3),and during the last week of the IP intake, just before the V3, also three days a week).

    Measured: 6 weeks

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

    Body weight (kg) is measured in subjects wearing underwear and no shoes

    Measured: 6 weeks

  3. Changes in BMI

    BMI is calculated as body weight (kg)/(height [m])2

    Measured: 6 weeks

  4. Changes in waist circumference

    Waist circumference (cm) is measured at the level midway between the lateral lower rib margin and the iliac crest

    Measured: 6 weeks

  5. Changes in hip circumference

    Hip circumference (cm) is measured as the maximal circumference over the buttocks

    Measured: 6 weeks

  6. Changes in body fat content using validated electronic weighing scales according to the Body composition analyser BC-420MA (a bio-impedance analysis (BIA))

    Measured as % and kg

    Measured: 6 weeks

  7. Changes in fat-free mass using validated electronic weighing scales according to the Body composition analyser BC-420MA (a bio-impedance analysis (BIA))

    Measured as % and kg

    Measured: 6 weeks

  8. Global evaluation of efficacy by subjects

    The subjects will evaluate independently the efficacy of the IP (globally scaled evaluation with "very good", "good", "moderate" and "poor").

    Measured: 6 weeks

  9. Global evaluation of efficacy by investigator

    The investigators will evaluate independently the efficacy of the IP (globally scaled evaluation with "very good", "good", "moderate" and "poor").

    Measured: 6 weeks

  10. Blood pressure

    Measured using standard devices after an at least 5-minute rest

    Measured: 6 weeks

  11. Pulse rate

    Measured using standard devices after an at least 5-minute rest

    Measured: 6 weeks

  12. Global evaluation of safety by subjects

    The subjects will evaluate independently the tolerability of the IP (global scaled evaluation with "very good", "good", "moderate" and "poor").

    Measured: 6 weeks

  13. Global evaluation of safety by investigator

    The investigators will evaluate independently the tolerability of the IP (global scaled evaluation with "very good", "good", "moderate" and "poor").

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2016 (estimated)
  2. Study start1 May 2016
  3. Primary completion20 Jul 2016
  4. Study completion20 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02774486
Sponsor's protocol ID
INQ/025115
Status last verified
Jan 2018
First submitted
22 Mar 2016
Last updated
3 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing IQP-AK-102 in people with Appetite Regulation and Appetite Suppression, run by InQpharm Group at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in appetite before and after breakfast 3 days a week (including one weekend day) using Haber Score (hunger, satiety) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02774486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.

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