Bioavailability of Curcuminoids From Turmipure Gold® in Different Food Matrices
A Randomized, Cross-over Clinical Trial to Study the Bioavailability of Curcuminoids From Turmipure Gold® in Different Food Matrices
2 other identifiers
interventional
35
1 country
1
Brief Summary
The goal of this clinical trial is to learn about the extent to which turmeric compounds in different food matrices becomes available to the body in healthy volunteers. The main question it aims to answer is:
- 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedFirst Submitted
Initial submission to the registry
February 6, 2024
CompletedFirst Posted
Study publicly available on registry
March 8, 2024
CompletedMarch 8, 2024
March 1, 2024
8 months
February 6, 2024
March 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose-normalized AUC0-24h of total curcuminoids
Normalized (according to mg of curcuminoids ingested) area under the concentration-time curve from 0 to 24 h of total curcuminoids (sum of all quantified metabolites) in plasma: * Total curcuminoids = curcumin + demethoxycurcumin (DMC) + bisdemethoxycurcumin (BDMC) + tetrahydrocurcumin (THC) + hexahydrocurcumin (HHC) + curcumin glucuronide + DMC glucuronide + BDMC glucuronide + THC glucuronide + HHC glucuronide + curcumin sulfate + DMC sulfate + BDMC sulfate + THC sulfate + HHC sulfate
0 to 24 hours
Secondary Outcomes (13)
Dose-normalized AUC0-24h of curcuminoid compounds and of their metabolites
0 to 24 hours
Dose-normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites
0 to 8 hours
Dose-normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites
Data collected from 0 to 24 hours
AUC0-24h of total curcuminoids, curcuminoid compounds and of their metabolites
0 to 24 hours
AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites
0 to 8 hours
- +8 more secondary outcomes
Study Arms (6)
Sequence capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink
EXPERIMENTALSubjects receive Turmipure Gold® preparations in different food matrices in the following order: capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink
Sequence dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar
EXPERIMENTALSubjects receive Turmipure Gold® preparations in different food matrices in the following order: dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar
Sequence gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink
EXPERIMENTALSubjects receive Turmipure Gold® preparations in different food matrices in the following order: gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink
Sequence probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule
EXPERIMENTALSubjects receive Turmipure Gold® preparations in different food matrices in the following order: probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule
Sequence ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies
EXPERIMENTALSubjects receive Turmipure Gold® preparations in different food matrices in the following order: ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies
Sequence sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog
EXPERIMENTALSubjects receive Turmipure Gold® preparations in different food matrices in the following order: sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog
Interventions
A dietary supplement product in capsule form containing 300 mg Turmipure Gold®
Ingredient stick containing 300 mg Turmipure Gold® mixed in 60 mL mango fruit nectar
Ingredient stick containing 300 mg Turmipure Gold® mixed in 240 mL oat milk
Ingredient stick containing 300 mg Turmipure Gold® mixed in a 100 mL probiotic yogurt drink base
Pectin gummies containing 300 mg Turmipure Gold®
Sport nutrition bar containing 300 mg Turmipure Gold®
Eligibility Criteria
You may qualify if:
- Age between 18 and 45 years (limits included)
- 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
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 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 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Givaudan France Naturalslead
- BioFortiscollaborator
Study Sites (1)
Biofortis
Saint-Herblain, 44800, France
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle Metreau, MD
BioFortis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2024
First Posted
March 8, 2024
Study Start
September 14, 2021
Primary Completion
May 20, 2022
Study Completion
May 20, 2022
Last Updated
March 8, 2024
Record last verified: 2024-03