Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to investigate the metabolization and the bioavailability of bioactive compounds from Sinetrol® Xpur, a polyphenol-rich ingredient, during a 16-week long chronical supplementation. It will be investigated the mechanism of action in adipocyte cells to try to explain the beneficial effects of the ingredient on body composition, especially on both abdominal subcutaneous and visceral fat mass.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum900 | Experimental | The arm will receive 900 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks |
|
| Verum1800 | Experimental | The arm will receive 1800 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum900 | Dietary Supplement | Sinetrol® Xpur is a blend of polyphenol-rich extracts from grapefruit, guarana seed, sweet orange and blood orange. Daily dosage is 900 mg for 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in urine polyphenol metabolites excretion after acute and chronic ingestion of the ingredient | Week 1 and Week 16 | |
| Change in plasma polyphenol metabolites concentration after acute and chronic ingestion of the ingredient | Week 1 and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fecal microbiota composition | Week 1, Week 8, Week 16 and Week 20 (follow-up) | |
| Change in blood microbiota composition | Week 1, Week 8, Week 16 and Week 20 (follow-up) | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pedro E Alcaraz Ramon | UCAM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCAM | Murcia | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39415279 | Derived | Muralidharan J, Romain C, Chung L, Alcaraz P, Martinez-Noguera FJ, Keophiphath M, Lelouvier B, Ancel P, Gaborit B, Cases J. Effect of Sinetrol(R) Xpur on metabolic health and adiposity by interactions with gut microbiota: a randomized, open label, dose-response clinical trial. Nutr Metab (Lond). 2024 Oct 16;21(1):83. doi: 10.1186/s12986-024-00851-7. | |
| 37943075 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Verum1800 | Dietary Supplement | Sinetrol® Xpur is a blend of polyphenol-rich extracts from grapefruit, guarana seed, sweet orange and blood orange. Daily dosage is 1800 mg for 16 weeks |
|
|
| Change in adipose tissue microbiota composition |
| Week 1 and Week 16 |
| Change in adipose tissue lipolysis assessed with glycerol concentration | Week 1 and Week 16 |
| Change in adipose tissue lipolysis assessed with free fatty acids concentration | Week 1 and Week 16 |
| Change in adipocytes diameters in adipose tissue | Week 1 and Week 16 |
| Change in adipose tissue secretion profile assessed by leptin concentration | Week 1 and Week 16 |
| Change in adipose tissue secretion profile assessed by adiponectin concentration | Week 1 and Week 16 |
| Change in total fat mass assessed by DXA | Week 1, Week 16 and Week 20 (follow-up) |
| Change in total fat-free mass assessed by DXA | Week 1, Week 16 and Week 20 (follow-up) |
| Change in abdominal fat mass assessed by MRI | Week 1 and Week 16 |
| Change in abdominal subcutaneous fat mass assessed by MRI | Week 1 and Week 16 |
| Change in abdominal visceral fat mass assessed by MRI | Week 1 and Week 16 |
| Change in energy expenditure assessed by indirect calorimetry | Week 1, Week 16 and Week 20 (follow-up) |
| Change in safety variables assessed by blood pressure variation (systole and diastole in mmHg) | Week 1 and Week 16 |
| Change in safety variables assessed by heart rate variation | Week 1 and Week 16 |
| Muralidharan J, Romain C, Bresciani L, Mena P, Angelino D, Del Rio D, Chung LH, Alcaraz PE, Cases J. Nutrikinetics and urinary excretion of phenolic compounds after a 16-week supplementation with a flavanone-rich ingredient. Food Funct. 2023 Nov 27;14(23):10506-10519. doi: 10.1039/d3fo02820h. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |