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Completed

NCT Number: NCT03888911

Benefit and Tolerability of IQP-LU-104 in Weight Loss

This study is to evaluate the benefit and tolerability of two dosages of IQP-LU-104 (5120mg and 2560mg daily) in reducing body weight in overweight and moderately obese subjects

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Key information

Conditions

Overweight Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Analyze & Realize

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
  • Overweight (BMI 25 to < 30 kg/m2) and moderately obese (BMI 30 to < 35 kg/m2) subjects
  • Generally in good health
  • Desire to lose weight
  • Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)
  • Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self-reported change)
  • Subject's agreement to comply with study procedures, in particular:
  • to take IP as recommended
  • to follow diet recommendation during the study
  • to complete the subject diary and study questionnaires
  • to maintain the habitual level of physical activity during the study
  • Women of childbearing potential:
  • commitment to use contraception methods
  • negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
  • Consents to participate, understands requirements of the study and is willing to comply

Exclusion criteria

  • Known sensitivity to the ingredients of the investigational product or source of ingredients
  • History and/or presence of clinically significant condition/disorder, which per investigator's judgment could interfere with the results of the study or the safety of the subject, e.g.:
  • untreated or non-stabilised thyroid gland disorder
  • untreated or non-stabilised hypertension (regular systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
  • acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.)
  • diabetes mellitus type 1
  • untreated or non-stabilised diabetes mellitus type 2
  • any other relevant serious organ or systemic diseases
  • Significant surgery within the last 6 months prior to V1:
  • GI surgery
  • liposuction
  • History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 months prior to V1
  • Deviation of safety laboratory parameter(s) at V1 that is:
  • clinically significant or
  • > 2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)
  • Any electronic medical implant
  • Regular medication and/or supplementation and/or treatment within the last month prior to V1 and during the study, which per investigator's judgment could interfere with the results of the study or the safety of the subject, e.g.:
  • that could influence body weight (e.g. systemic cortcosteroids, antipsychotics, anti-depressants)
  • that could influence gastrointestinal functions (e.g. antibiotics, laxatives, opioids, anticholinergics etc.) as per investigator judgment
  • for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner, satiety products etc.)
  • any other relevant medication and/or supplementation
  • Diet/weight loss programs within the last 3 months prior to V1 and during the study
  • 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)
  • Vegetarian, vegan or other restrictive diet
  • Women of child-bearing potential: pregnancy or nursing
  • History of or current abuse of drugs, alcohol or medication
  • Participation in another clinical study in the 30 days prior to V1 and during the study
  • Any other reason for exclusion as per investigator's judgment

Treatment and study plan

High dose IQP-LU-104 (5120mg)

Dietary Supplement

1 sachet to be taken 2 times daily orally, together with 2 main meals

Low dose IQP-LU-104 (2560mg)

Dietary Supplement

1 sachet to be taken 2 times daily orally, together with 2 main meals

Placebo

Dietary Supplement

1 sachet to be taken 2 times daily orally, together with 2 main meals

Primary outcomes

  1. Mean change in body weight (kg)

    Time frame: 12 weeks

    Difference in mean change of body weight (kg) between the higher dosed verum and placebo group after 12 weeks of intervention in comparison to baseline

  2. Mean change in body weight (kg)

    Time frame: 12 weeks

    Difference in mean change of body weight (kg) between the lower dosed verum and placebo group after 12 weeks of intervention in comparison to baseline

Secondary outcomes

  1. Mean change in body weight (kg)

    Time frame: 4 and 8 weeks

    Difference between the higher dosed verum and placebo group in mean change of body weight (kg) after 4 and 8 weeks of intervention, each in comparison to baseline

  2. Mean change in body weight (kg)

    Time frame: 4 and 8 weeks

    Difference between the lower dosed verum and placebo group in mean change of body weight (kg) after 4 and 8 weeks of intervention, each in comparison to baseline

  3. Body weight (kg)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in body weight (kg) after 4, 8, and 12 weeks of intervention

  4. Change in body weight percentage (%)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the changes in body weight (%) after 4, 8, and 12 weeks of intervention, each in comparison to baseline

  5. Proportion of subjects with weight loss

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the proportion of subjects who lost at least 3%, 5% and 10% of baseline body weight after 4, 8, and 12 weeks of intervention, each in comparison to baseline

  6. Waist circumference (cm)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in waist circumference (cm) after 4, 8, and 12 weeks of intervention

  7. Change in waist circumference (cm)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the changes in waist circumference (cm) after 4, 8, and 12 weeks of intervention, each in comparison to baseline

  8. Hip circumference (cm)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in hip circumference (cm) after 4, 8, and 12 weeks of intervention

  9. Change in hip circumference (cm)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the changes in hip circumference (cm) after 4, 8, and 12 weeks of intervention, each in comparison to baseline

  10. Waist-hip ratio

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in waist-hip ratio after 4, 8, and 12 weeks of intervention

  11. Change in waist-hip ratio

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the changes in waist-hip ratio after 4, 8, and 12 weeks of intervention, each in comparison to baseline

  12. BMI (kg/m^2)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in BMI (kg/m^2) after 4, 8, and 12 weeks of intervention

  13. Change in BMI (kg/m^2)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo group in the changes in BMI (kg/m^2) after 4, 8, and 12 weeks of intervention, each in comparison to baseline

  14. Body fat percentage (%)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in body fat (%) after 4, 8, and 12 weeks of intervention

  15. Change in body fat percentage (%)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the changes in body fat (%) after 4, 8, and 12 weeks of intervention, each in comparison to baseline

  16. Body fat mass (kg)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in body fat mass (kg) after 4, 8, and 12 weeks of intervention

  17. Change in body fat mass (kg)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the changes in body fat mass (kg) after 4, 8, and 12 weeks of intervention, each in comparison to baseline

  18. Fat free mass (kg)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in fat free mass (kg) after 4, 8, and 12 weeks of intervention

  19. Change in fat free mass (kg)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the changes in fat free mass (kg) after 4, 8, and 12 weeks of intervention, each in comparison to baseline

  20. Evaluation of feeling of hunger using visual analogue scales (VAS)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the evaluation of feelings of hunger using VAS after 4, 8, and 12 weeks of intervention

  21. Change in the evaluation of feeling of hunger using visual analogue scales (VAS)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the changes in evaluation of feelings of hunger using VAS after 4, 8, and 12 weeks of intervention, each in comparison to baseline

  22. Evaluation of feeling of satiety using visual analogue scales (VAS)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the evaluation of feelings of satiety using VAS after 4, 8, and 12 weeks of intervention

  23. Change in the evaluation of feeling of satiety using visual analogue scales (VAS)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the changes in evaluation of feelings of satiety using VAS after 4, 8, and 12 weeks of intervention, each in comparison to baseline

  24. Evaluation of feeling of fullness using visual analogue scales (VAS)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the evaluation of feelings of fullness using VAS after 4, 8, and 12 weeks of intervention

  25. Change in the evaluation of feeling of fullness using visual analogue scales (VAS)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the changes in evaluation of feelings of fullness using VAS after 4, 8, and 12 weeks of intervention, each in comparison to baseline

  26. Evaluation of feeling of craving using visual analogue scales (VAS)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the evaluation of feelings of craving using VAS after 4, 8, and 12 weeks of intervention

  27. Change in the evaluation of feeling of craving using visual analogue scales (VAS)

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the changes in evaluation of feelings of craving using VAS after 4, 8, and 12 weeks of intervention, each in comparison to baseline

  28. Change in the quality of life using Impact of Weight on Quality of Life (IWQOL-Lite) Questionnaire

    Time frame: 4, 8, 12 weeks

    Difference between the two verum and placebo groups in the changes in quality of life using (IWQOL-Lite) questionnaire after 4, 8 and 12 weeks of intervention, each in comparison to baseline

  29. Lipid metabolism parameters (mmol/l)

    Time frame: 12 weeks

    Difference between the two verum and placebo groups in total cholesterol (mmol/l), LDL-cholesterol (mmol) and HDL cholesterol (mmol) after 12 weeks of intervention

  30. Change in lipid metabolism parameters (mmol/l)

    Time frame: 12 weeks

    Difference between the two verum and placebo groups in the changes in lipid metabolism parameters after 12 weeks of intervention, each in comparison to baseline

  31. HbA1C percentage (%)

    Time frame: 12 weeks

    Difference between the two verum and placebo groups in HbA1C (%) after 12 weeks of intervention

  32. Change in HbA1C percentage (%)

    Time frame: 12 weeks

    Difference between the two verum and placebo groups in the changes in HbA1C (%) after 12 weeks of intervention, each in comparison to baseline

Other outcomes

  1. Safety parameters (lab parameters and vital signs)

    Time frame: 12 weeks

    Assessment of laboratory results in full blood count, clinical chemistry, blood pressure and pulse rate

Sponsors and collaborators

Lead sponsor

InQpharm Group

Industry

Registry information

Official study title

Double-blind, Randomized, Three-armed, Placebo-controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-LU-104 in Reducing Body Weight in Overweight and Moderately Obese Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 25, 2019
Registry last updated
Aug 3, 2022

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.

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