A Clinical Trial to Evaluate the Chronic Safety and Tolerance of Turmipure Gold™ in Healthy Subjects

NCT03945149 | Completed

• 1 other identifier: ID-RCB 2019-A00299-48
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Tolerance; Liver Function; Kidney Function

Outcome Measures

Primary Outcomes (1)

• composite score of gastrointestinal tolerance

  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\*

  5 weeks +/- 3 days (V2)

Secondary Outcomes (70)

• Individual gastrointestinal symptoms (Bristol Stool Chart)

  V1 (Day 0)

• Individual gastrointestinal symptoms (Bristol Stool Chart)

  5 weeks +/- 3 days (V2)

• Individual gastrointestinal symptoms (Lickert scale)

  V1 (Day 0)

• Individual gastrointestinal symptoms (Lickert scale)

  5 weeks +/- 3 days (V2)

• Haematological safety parameters: blood count-formula

  V1 (Day 0)

Other Outcomes (3)

• occurrence of adverse events

  V0 (-14days)

• occurrence of adverse events

  V1 (Day 0)

• occurrence of adverse events

  V2 (5 weeks +/- 3 days)

Study Arms (2)

Turmipure Gold™

ACTIVE COMPARATOR

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™

Placebo

PLACEBO COMPARATOR

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

Interventions

Turmipure Gold™ DIETARY_SUPPLEMENT

30 subjects will take 1000mg in 4 capsules (with 250ml water before breakfast , each day, during 5 weeks

Turmipure Gold™

Placebo DIETARY_SUPPLEMENT

30 subjects will take 4 capsules with 250ml water before breakfast , each day, during 5 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Givaudan France Naturals: lead
• BioFortis: collaborator

Study Sites (1)

Biofortis Mérieux NutriSciences

Saint-Herblain, 44800, France

Location

Study Officials

• Pascale Fança-Berthon, PhD

  Naturex

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This safety and tolerance 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.

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 10, 2019
• Study Start: May 9, 2019
• Primary Completion: July 26, 2019
• Study Completion: July 26, 2019
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)