Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Clinical Trial to Evaluate the Chronic Safety and Tolerance of Turmipure Gold™ in Healthy Subjects (TURBIO-GOLD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03945149
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
BioFortis
Information provided by (Responsible Party):
Naturex SA

Brief Summary:
The aim of this study is to evaluate the safety and tolerance of Turmipure Gold™ product during a chronic consumption of 5 weeks in healthy subjects. The hypothesis of this study is that there are no alterations of the gastrointestinal tolerance, of the haematological and biochemical profiles due to Turmipure Gold™ consumption compared to placebo.

Condition or disease Intervention/treatment Phase
Gastrointestinal Tolerance Liver Function Kidney Function Dietary Supplement: Turmipure Gold™ Dietary Supplement: Placebo Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This pharmacokinetic study is designed as a monocentric, randomized, parallel arms, double-blind, placebo-controlled clinical trial.

Three visits planned: a screening visit (V0) for subjects selection, a randomization visit (V1 with product dispensation, 2 weeks after V0) and a end-of-study visit (V2, 5 weeks after V1). between V1 and V2, a telephone interview will be organized with each subject to evoke the tolerance of the product at mid-term.

An additional end-of-study visit could be planned if the biological results of the V2 visit are not satisfactory, according to the opinion of the investigator.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Double-blind Placebo-controlled Clinical Trial to Evaluate the Chronic Safety and Tolerance of Turmipure Gold™ in Healthy Subjects
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Active Comparator: Turmipure Gold™
30 subjects will be randomized under active arm and will receive Active Product at V1 and until V2 (5 weeks of treatment).
Dietary Supplement: Turmipure Gold™
30 subjects will take 1000mg in 4 capsules (with 250ml water before breakfast , each day, during 5 weeks

Placebo Comparator: Placebo
30 subjects will be randomized under Placebo arm and will receive placebo Product at V1 and until V2 (5 weeks of treatment).
Dietary Supplement: Placebo
30 subjects will take 4 capsules with 250ml water before breakfast , each day, during 5 weeks




Primary Outcome Measures :
  1. composite score of gastrointestinal tolerance [ Time Frame: 5 weeks +/- 3 days (V2) ]

    The primary endpoint in this study is the composite score of gastrointestinal tolerance (Bristol stool chart and Lickert scale) after 5 weeks of supplementation +/- 3 days (a.u./day, range 0-50), expressed in a.u

    This composite score will be defined as the sum of the ratings of GI symptoms scores and the composite score of stool frequency and consistency (36):

    Composite GI symptoms tolerance = Bloating score + Abdominal cramping score + Stomach noises score + Flatulence score + Stool score*



Secondary Outcome Measures :
  1. Individual gastrointestinal symptoms (Bristol Stool Chart) [ Time Frame: V1 (Day 0) ]

    Bristol Stool chart is used - this scale allows to measure to evaluate stool frequency and consistency. The Bristol Stool Chart or Bristol Stool Scale is a medical aid designed to classify faeces into seven groups. The Bristol Stool Chart shows seven categories of stool:

    Type 1-2 indicate constipation Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhoea and urgency.


  2. Individual gastrointestinal symptoms (Bristol Stool Chart) [ Time Frame: 5 weeks +/- 3 days (V2) ]

    Bristol Stool chart is used - this scale allows to measure to evaluate stool frequency and consistency. The Bristol Stool Chart or Bristol Stool Scale is a medical aid designed to classify faeces into seven groups. The Bristol Stool Chart shows seven categories of stool:

    Type 1-2 indicate constipation Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhoea and urgency.


  3. Individual gastrointestinal symptoms (Lickert scale) [ Time Frame: V1 (Day 0) ]

    Lickert scale was used to evaluate gastro-intestinal symptoms. The gastro-intestinal symptoms will be reported during 3 days before V1 visit. A mean of these 3 days will be calculated. Each GI symptom will be given a score of 0 (no symptoms) to 10 (severe symptoms).

    This scale allow to have four scores :

    • Bloating score (a.u./day, range 0-10),
    • Abdominal cramping score (a.u./day, range 0-10),
    • Stomach noises score (= Borborygmi) (a.u./day, range 0-10),
    • Flatulence score (a.u./day, range 0-10), These scores will be combined to evaluate the gestointestinal symptoms

  4. Individual gastrointestinal symptoms (Lickert scale) [ Time Frame: 5 weeks +/- 3 days (V2) ]

    Lickert scale was used to evaluate gastro-intestinal symptoms. The gastro-intestinal symptoms will be reported during 3 days before V1 visit. A mean of these 3 days will be calculated. Each GI symptom will be given a score of 0 (no symptoms) to 10 (severe symptoms).

    This scale allow to have four scores :

    • Bloating score (a.u./day, range 0-10),
    • Abdominal cramping score (a.u./day, range 0-10),
    • Stomach noises score (= Borborygmi) (a.u./day, range 0-10),
    • Flatulence score (a.u./day, range 0-10), These scores will be combined to evaluate the gestointestinal symptoms

  5. Haematological safety parameters: blood count-formula [ Time Frame: V1 (Day 0) ]
    blood count-formula

  6. Haematological safety parameters: blood count-formula [ Time Frame: 5 weeks +/- 3 days (V2) ]
    blood count-formula

  7. Sodium mmol/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  8. Sodium mmol/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  9. Potassium mmol/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  10. Potassium mmol/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  11. Chloride mmol/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  12. Chloride mmol/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  13. Calcium mmol/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  14. Calcium mmol/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  15. Inorganic Phosphorus mmol/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  16. Inorganic Phosphorus mmol/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  17. Glucose mmol/L or g/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  18. Glucose mmol/L or g/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  19. Urea mmol/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  20. Urea mmol/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  21. Creatinine µmol/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  22. Creatinine µmol/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  23. Total bilirubin µmol/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  24. Total bilirubin µmol/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  25. Total cholesterol (mmol/L or g/L) dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  26. LDL (mmol/L) dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  27. LDL (mmol/L) dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  28. HDL-cholesterol (mmol/L) dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  29. HDL-cholesterol (mmol/L) dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  30. Total cholesterol (mmol/L or g/L) dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  31. Triglycerides mmol/L or g/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  32. Triglycerides mmol/L or g/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  33. Alkaline phosphatase (ALP) µkat/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  34. Alkaline phosphatase (ALP) µkat/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  35. Aspartate aminotransferase (ASAT) µkat/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  36. Aspartate aminotransferase (ASAT) µkat/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  37. Alanine aminotransferase (ALAT) µkat/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  38. Alanine aminotransferase (ALAT) µkat/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  39. Total proteins g/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  40. Total proteins g/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  41. Albumin g/L dosage [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  42. Albumin g/L dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  43. Albumin/globulin ratio. [ Time Frame: V1 (Day 0) ]
    Biochemical blood safety parameters

  44. Albumin/globulin ratio. [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Biochemical blood safety parameters

  45. glucose dosage [ Time Frame: V1 (Day 0) ]
    Urinary safety parameters

  46. glucose dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Urinary safety parameters

  47. protein dosage [ Time Frame: V1 (Day 0) ]
    Urinary safety parameters

  48. protein dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Urinary safety parameters

  49. potential Hydrogen (pH) [ Time Frame: V1 (Day 0) ]
    Urinary safety parameters

  50. potential Hydrogen (pH) [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Urinary safety parameters

  51. blood presence [ Time Frame: V1 (Day 0) ]
    Urinary safety parameters

  52. blood presence [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Urinary safety parameters

  53. ketonic corpse [ Time Frame: V1 (Day 0) ]
    Urinary safety parameters

  54. ketonic corpse [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Urinary safety parameters

  55. nitrites dosage [ Time Frame: V1 (Day 0) ]
    Urinary safety parameters

  56. nitrites dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Urinary safety parameters

  57. density [ Time Frame: V1 (Day 0) ]
    Urinary safety parameters

  58. density [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Urinary safety parameters

  59. bilirubin dosage [ Time Frame: V1 (Day 0) ]
    Urinary safety parameters

  60. bilirubin dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Urinary safety parameters

  61. urobilinogen dosage [ Time Frame: V1 (Day 0) ]
    Urinary safety parameters

  62. urobilinogen dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Urinary safety parameters

  63. leukocytes dosage [ Time Frame: V1 (Day 0) ]
    Urinary safety parameters

  64. leukocytes dosage [ Time Frame: 5 weeks +/- 3 days (V2) ]
    Urinary safety parameters

  65. quality of life score [ Time Frame: V1 (Day 0) ]

    The GastoIntestinal quality of Life (GIQLI) questionnaire is composed of 36 items. The responses for each item are scored from 0 to 4, from the worst to the best rating. Example of answers to question 1: always (0), most of the time (1), sometimes (2), rarely (3), never (4).

    The average overall score for each subject and visit will be calculated by summing the scores of each question divided by 144 and multiplied by 100 (average overall score reduced to a score between 0 and 100; the maximum score being 100) (Slim et al., 1999).

    The items focus on 5 subscales (Slim et al., 1999):

    • Symptoms (19 items): items 1 to 9 and 27 to 36 (theoretical score range: 0-76),
    • Fitness (7 items): items 15 to 21 (theoretical score range : 0-28),
    • Emotions (5 items): items 10 to 14 (theoretical score range: 0-20),
    • Social integration (4 items): items 22, 23, 25 and 26 (theoretical scope range: 0-16),
    • The effect of possible medical treatment (1 item): item 24 (theoretical score range: 0-4).

  66. quality of life score [ Time Frame: 5 weeks +/- 3 days (V2) ]

    The GastoIntestinal quality of Life (GIQLI) questionnaire is composed of 36 items. The responses for each item are scored from 0 to 4, from the worst to the best rating. Example of answers to question 1: always (0), most of the time (1), sometimes (2), rarely (3), never (4).

    The average overall score for each subject and visit will be calculated by summing the scores of each question divided by 144 and multiplied by 100 (average overall score reduced to a score between 0 and 100; the maximum score being 100) (Slim et al., 1999).

    The items focus on 5 subscales (Slim et al., 1999):

    • Symptoms (19 items): items 1 to 9 and 27 to 36 (theoretical score range: 0-76),
    • Fitness (7 items): items 15 to 21 (theoretical score range : 0-28),
    • Emotions (5 items): items 10 to 14 (theoretical score range: 0-20),
    • Social integration (4 items): items 22, 23, 25 and 26 (theoretical scope range: 0-16),
    • The effect of possible medical treatment (1 item): item 24 (theoretical score range: 0-4).

  67. 3 days Food diary [ Time Frame: V1 (Day 0) ]

    This diary will be filled by subjects the week before V1 visit and the data will be collected and analyzed by a dietician.

    This diary will allow to evaluate food intake :

    • total energy intake (kcal),
    • percentage of energy intake from proteins (%),
    • percentage of energy intake from fat (%),
    • percentage of energy intake from carbohydrates (%),
    • dietary fiber (g) and hydric intake,

    These data will be combined to evaluate the food intake


  68. 3 days Food diary [ Time Frame: 5 weeks +/- 3 days (V2) ]

    This diary will be filled by subjects the week before V2 visit and the data will be collected and analyzed by a dietician.

    This diary will allow to evaluate food intake :

    • total energy intake (kcal),
    • percentage of energy intake from proteins (%),
    • percentage of energy intake from fat (%),
    • percentage of energy intake from carbohydrates (%),
    • dietary fiber (g) and hydric intake,

    These data will be combined to evaluate the food intake


  69. Physical activity global score [ Time Frame: V1 (Day 0) ]

    This self-administered questionnaire IPAQ will be filled by subjects at V1 visit. For each subject and visit, the total metabolic equivalent will be calculated from the IPAQ questionnaire short form.

    This continuous score, expressed as MET-min per week (MET level x Number of minutes of activity/day x Number of days per week), will be calculated using the following formula (Guideline IPAQ, 2005):

    Total MET-minutes/week = Walking (METs*min*days) + Moderate intensity (METs*min*days) + Vigorous intensity (METs*min*days) with: . Walking = 3.3 METs;

    • Moderate Intensity = 4.0 METs;
    • Vigorous Intensity = 8.0 METs.

  70. Physical activity global score [ Time Frame: 5 weeks +/- 3 days (V2) ]

    This self-administered questionnaire IPAQ will be filled by subjects at V2 visit. For each subject and visit, the total metabolic equivalent will be calculated from the IPAQ questionnaire short form.

    This continuous score, expressed as MET-min per week (MET level x Number of minutes of activity/day x Number of days per week), will be calculated using the following formula (Guideline IPAQ, 2005):

    Total MET-minutes/week = Walking (METs*min*days) + Moderate intensity (METs*min*days) + Vigorous intensity (METs*min*days) with: . Walking = 3.3 METs;

    • Moderate Intensity = 4.0 METs;
    • Vigorous Intensity = 8.0 METs


Other Outcome Measures:
  1. occurrence of adverse events [ Time Frame: V0 (-14days) ]
    Safety objectives

  2. occurrence of adverse events [ Time Frame: V1 (Day 0) ]
    Safety objectives

  3. occurrence of adverse events [ Time Frame: V2 (5 weeks +/- 3 days) ]
    Safety objectives



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 18 and 60 years (limits included),
  • BMI between 19 and 28kg/m² (limits included),
  • Weight stable within ±3kg in the last three months,
  • With routine blood chemistry values within the normal range,
  • For women: Non menopausal with the same reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study (condom with spermicidal gel and estrogen/progestin combination contraception accepted) or menopausal without or with hormone replacement therapy (estrogenic replacement therapy begun from less than 3 months excluded),
  • Non-smoking or with tobacco consumption ≤ 5 cigarettes / day and agreeing not to smoke during all experimental sessions (V1 and V2),
  • Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination,
  • Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
  • Affiliated with a social security scheme,
  • Agreeing to be registered on the volunteers in biomedical research file.

Exclusion Criteria:

  • Suffering from a metabolic or endocrine disorder such as diabetes, uncontrolled or controlled thyroidal trouble or other metabolic disorder,
  • Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, ongoing hepatic or biliary disorders, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease),
  • Suffering from liver diseases,
  • Current disease states that are contraindicated to subjects with dietary supplementation: chronic diarrhea, constipation or abdominal pain, Inflammatory bowel diseases (Crohn's disease or ulcerative colitis), Cirrhosis, chronic laxatives use…,
  • Suffering from Irritable Bowel Syndrome (IBS) diagnosed or not by a medical doctor and treated with chronic medication,
  • Having medical history of current pathology which could affect the study results or expose the subject to an additional risk according to the investigator,
  • Recent gastroenteritis or food borne illness such as confirmed food poisoning (less than 1 month),
  • With a low veinous capital of blood samples according to the investigator's opinion,
  • With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient (gluten intolerance, celiac disease, etc….),
  • Pregnant or lactating women or intending to become pregnant within 3 months ahead,
  • Exhibiting alcohol or drug dependence,
  • On any chronic drug treatment (for example anticoagulant, antihypertensive treatment, treatment thyroid, asthma treatment, anxiolytic, antidepressant, lipid-lowering treatment, corticosteroids, phlebotonic, venotonic, drug with impact on blood circulation …) excepting oral and local contraceptives,
  • Currently taking (and during the last month) any supplementation from botanical origins or with curcumin,
  • Currently taking (and during the past 3 months) any prebiotics or probiotics supplementation from food or from dietary supplements,
  • With significant change in food habits or in physical activity in the 3 months before the V0 visit or not agreeing to keep them unchanged throughout the study,
  • Trying to lose weight with a current or planned in the next 3 months specific diet (hyper or hypocaloric, vegan, vegetarian…) or exercise regimen,
  • With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator,
  • Consuming more than 3 standard drinks of alcoholic beverage daily for men or 2 daily for women or not agreeing to keep his alcohol consumption habits unchanged throughout the study,
  • Having a lifestyle deemed incompatible with the study according to the investigator including high level physical activity (defined as more than 10 hours of significant physical activity a week, walking excluded),
  • Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
  • Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros,
  • Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
  • Presenting a psychological or linguistic incapability to sign the informed consent,
  • Impossible to contact in case of emergency.

After V0 biological analyses the subject will be considered as non-eligible to the study on the following criteria:

- Control record (Glycaemia, Gamma glutamyl transpeptidase (GGT), ASAT, ALAT, Urea, Creatinine and Complete blood count) with clinically significant abnormality according to the investigator.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945149


Contacts
Layout table for location contacts
Contact: Pascale Fança-Berthon, PhD +33(0)490239689 p.fancaberthon@naturex.com
Contact: Sabrina Le Bouter-Banon, PhD +33(0)240202629 sabrina.lebouter-banon@mxns.com

Locations
Layout table for location information
France
Biofortis Mérieux NutriSciences Recruiting
Saint-Herblain, France, 44800
Contact: Sabrina Le Bouter-Banon, PhD    +33(0)240202629    sabrina.lebouter-banon@mxns.com   
Principal Investigator: Isabelle METREAU, MD         
Sponsors and Collaborators
Naturex SA
BioFortis
Investigators
Layout table for investigator information
Study Director: Pascale Fança-Berthon, PhD Naturex

Layout table for additonal information
Responsible Party: Naturex SA
ClinicalTrials.gov Identifier: NCT03945149     History of Changes
Other Study ID Numbers: ID-RCB 2019-A00299-48
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No