Bioavailability of Curcuminoids From Turmipure Gold® in Different Food Matrices
NCT ID: NCT06300021
Last Updated: 2024-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2021-09-14
2022-05-20
Brief Summary
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* Is the availability to the body of a turmeric dietary supplement altered when consumed in fruit nectar, oat milk, yogurt drink, or gummies in comparison to a dietary supplement capsule?
Participants will ingest a turmeric dietary supplement as a capsule or in different food matrices on six testing days (separated by at least one week). The day before testing day, a standardized dinner will be provided to the participants in the evening and participants will be instructed to not consume any foods or beverages (except water) and to arrive fasted (12 hours) at the investigation site. Participants will ingest turmeric dietary supplement formulations one by one in random order in the morning of testing days. Regular blood and urine samples will be collected before and up to 24 hours after the turmeric dietary supplement ingestion. Standardized meals will be provided during the entire testing day (lunch, mid-afternoon snack, dinner).
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Detailed Description
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In the present trial, the aim is to assess the bioavailability of curcuminoids in different food matrix formulations, the capsule format being the reference matrix, with a hypothesis of equivalence. The primary objective of the study is to assess the plasmatic concentration profile of total curcuminoids (curcumin, DMC, BDMC and their metabolites) on a 24-hour period after consumption of five different food matrix formulations containing TPG in comparison to the dietary supplement capsule formulation.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Sequence capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink
Subjects receive Turmipure Gold® preparations in different food matrices in the following order: capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink
TPG capsule
A dietary supplement product in capsule form containing 300 mg Turmipure Gold®
TPG ready to drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in 60 mL mango fruit nectar
TPG dairy analog
Ingredient stick containing 300 mg Turmipure Gold® mixed in 240 mL oat milk
TPG probiotic drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in a 100 mL probiotic yogurt drink base
TPG gummies
Pectin gummies containing 300 mg Turmipure Gold®
TPG sport bar
Sport nutrition bar containing 300 mg Turmipure Gold®
Sequence dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar
Subjects receive Turmipure Gold® preparations in different food matrices in the following order: dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar
TPG capsule
A dietary supplement product in capsule form containing 300 mg Turmipure Gold®
TPG ready to drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in 60 mL mango fruit nectar
TPG dairy analog
Ingredient stick containing 300 mg Turmipure Gold® mixed in 240 mL oat milk
TPG probiotic drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in a 100 mL probiotic yogurt drink base
TPG gummies
Pectin gummies containing 300 mg Turmipure Gold®
TPG sport bar
Sport nutrition bar containing 300 mg Turmipure Gold®
Sequence gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink
Subjects receive Turmipure Gold® preparations in different food matrices in the following order: gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink
TPG capsule
A dietary supplement product in capsule form containing 300 mg Turmipure Gold®
TPG ready to drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in 60 mL mango fruit nectar
TPG dairy analog
Ingredient stick containing 300 mg Turmipure Gold® mixed in 240 mL oat milk
TPG probiotic drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in a 100 mL probiotic yogurt drink base
TPG gummies
Pectin gummies containing 300 mg Turmipure Gold®
TPG sport bar
Sport nutrition bar containing 300 mg Turmipure Gold®
Sequence probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule
Subjects receive Turmipure Gold® preparations in different food matrices in the following order: probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule
TPG capsule
A dietary supplement product in capsule form containing 300 mg Turmipure Gold®
TPG ready to drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in 60 mL mango fruit nectar
TPG dairy analog
Ingredient stick containing 300 mg Turmipure Gold® mixed in 240 mL oat milk
TPG probiotic drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in a 100 mL probiotic yogurt drink base
TPG gummies
Pectin gummies containing 300 mg Turmipure Gold®
TPG sport bar
Sport nutrition bar containing 300 mg Turmipure Gold®
Sequence ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies
Subjects receive Turmipure Gold® preparations in different food matrices in the following order: ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies
TPG capsule
A dietary supplement product in capsule form containing 300 mg Turmipure Gold®
TPG ready to drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in 60 mL mango fruit nectar
TPG dairy analog
Ingredient stick containing 300 mg Turmipure Gold® mixed in 240 mL oat milk
TPG probiotic drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in a 100 mL probiotic yogurt drink base
TPG gummies
Pectin gummies containing 300 mg Turmipure Gold®
TPG sport bar
Sport nutrition bar containing 300 mg Turmipure Gold®
Sequence sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog
Subjects receive Turmipure Gold® preparations in different food matrices in the following order: sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog
TPG capsule
A dietary supplement product in capsule form containing 300 mg Turmipure Gold®
TPG ready to drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in 60 mL mango fruit nectar
TPG dairy analog
Ingredient stick containing 300 mg Turmipure Gold® mixed in 240 mL oat milk
TPG probiotic drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in a 100 mL probiotic yogurt drink base
TPG gummies
Pectin gummies containing 300 mg Turmipure Gold®
TPG sport bar
Sport nutrition bar containing 300 mg Turmipure Gold®
Interventions
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TPG capsule
A dietary supplement product in capsule form containing 300 mg Turmipure Gold®
TPG ready to drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in 60 mL mango fruit nectar
TPG dairy analog
Ingredient stick containing 300 mg Turmipure Gold® mixed in 240 mL oat milk
TPG probiotic drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in a 100 mL probiotic yogurt drink base
TPG gummies
Pectin gummies containing 300 mg Turmipure Gold®
TPG sport bar
Sport nutrition bar containing 300 mg Turmipure Gold®
Eligibility Criteria
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Inclusion Criteria
* BMI between 18.5 and 24.9 kg/m² (limits included)
* Weight stable within ±3 kg 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 or menopausal without or with hormone replacement therapy since at least 3 months
* Non-smoking or with tobacco consumption ≤5 cigarettes per day and agreeing not to smoke during the entire duration of the study
* Good general and mental health 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 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 chronic disease (e.g. cancer, HIV, kidney failure, ongoing hepatic or biliary disorders, chronic inflammatory digestive disease, arthritis, anemia or other chronic respiratory trouble, gammapathies, hepatic diseases, decompensated diabetes, tuberculosis, ulcerative colitis, parkinson's disease, 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
* Having medical history of current pathology which could affect the study results or expose the subject to an additional risk according to the investigator (IBS, chronic diarrhea, constipation or abdominal pain, inflammatory bowel diseases (Crohn's disease or ulcerative colitis), cirrhosis, chronic laxatives use, severe COVID-19 history (requiring oxygen-therapy) in the 12 past months, …)
* Recent gastroenteritis or food borne illness such as confirmed food poisoning (less than 1 month)
* With a low venous capital of blood samples according to the investigator's opinion
* With a known or suspected allergy or intolerance to any food
* With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient or turmeric and/or of the standard meals
* Pregnant or lactating women or intending to become pregnant within 3 months ahead
* Currently taking any chronic drug treatment (for example: antidiabetics, anticoagulant, antihypertensive treatment, treatment thyroid, asthma treatment, anxiolytic, antidepressant, lipid-lowering treatment, corticosteroids, phlebotonic, veinotonic, drug with impact on blood circulation, …) except oral and local contraceptives,
* Currently taking or having taken any supplementation from botanical origins or with curcumin in the previous 3 months before inclusion
* Currently taking or having taken laxatives or antibiotics, in the previous 3 months before the V0 visit
* Currently taking or having taken any prebiotics or probiotics supplementation from food or from dietary supplements in the previous 3 months before the V0 visit
* 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
* Exhibiting alcohol or consuming more than 3 standard drinks of alcoholic beverage daily for men or 2 daily for women or not agreeing to keep alcohol consumption habits unchanged throughout the study or drug dependence or exhibiting drug dependence
* Having a lifestyle deemed incompatible with the study according to the investigator including high level physical activity (defined as more than 5 hours of significant physical activity a week, walking excluded)
* Having taken part in another clinical trial in the previous 3 months 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 rights following administrative or judicial decision
* Presenting a psychological or linguistic incapability to sign the informed consent
* Impossible to contact in case of emergency
* Having consumed curcumin-containing food supplements (curcumin, turmeric and curry) or foods (curcumin, turmeric, E100, and curry) defined as at least 3 times per week and for 2 weeks prior to testing
* Made a blood donation in the 3 months before the V0 visit or intending to make it within 3 months ahead
* After V0 biological analyses the subject will be considered as non-eligible to the study on the following criteria: Control record (glycaemia, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, GGT, ASAT, ALAT, urea, creatinine, total bilirubin and CBC) with clinically significant abnormality according to the investigator
18 Years
45 Years
ALL
Yes
Sponsors
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BioFortis
OTHER
Givaudan France Naturals
INDUSTRY
Responsible Party
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Principal Investigators
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Isabelle Metreau, MD
Role: PRINCIPAL_INVESTIGATOR
BioFortis
Locations
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Biofortis
Saint-Herblain, , France
Countries
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Other Identifiers
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2021-A00317-34
Identifier Type: OTHER
Identifier Source: secondary_id
PEC19242
Identifier Type: -
Identifier Source: org_study_id
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