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| Name | Class |
|---|---|
| San Antonio Technologies - San Antonio Catholic University of Murcia | OTHER |
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The main objective of this intervention study was to evaluate the functionality of a multi-target preparation (rich in phloretin from apple, chromium picolinate, zinc, magnesium and cinnamon extract) on the glucose response of individuals who show factors associated with prediabetes.
An interventional study was conducted in collaboration with the Catholic University of San Antonio Murcia (UCAM). A total of 21 prediabetic volunteers (fasting blood glucose levels between 100 and 120 mg/dL) who were not taking diabetes medication or antibiotics during the study were recruited. Pregnant or lactating women were also excluded.
The participants were invited to an information session to learn more about the study objectives and procedures, and they signed informed consent forms. During this first visit, anthropometric measurements were taken, and a questionnaire was administered to gather information about their diet and physical activity. Each volunteer made four more visits to the UCAM facilities. On each visit, the volunteers ingested either a placebo capsule or the formulated dietary supplement, followed by a standard breakfast consisting of three toasted bread slices and two single-serving packets of strawberry or peach jam (resulting in a total carbohydrate intake of 49.5 g). The volunteers were randomly assigned to receive the placebo or the supplemet and each of them was taken twice. At time 0 and at different times after breakfast intake (15, 30, 45, 60, 75, 90, 105 and 120 min) blood glucose was measured using capillary blood sample obtained by finger prick and a glucometer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo capsule | Placebo Comparator | Participants receive a matching placebo during their assigned period. |
|
| Active Capsules | Experimental | Participants receive the supplement during their assigned period. |
|
| Placebo capsule (repetition) | Placebo Comparator | This arm was a repetition of the placebo intake |
|
| Active capsules (repetition) | Experimental | This arm was a repetition of the supplement intake |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Capsules with microcrystalline cellulose 102 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental Area Under the Curve (iAUC) of blood glucose over 120 minutes | Capillary blood glucose was monitored using a glucometer | 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of breakfast with each capsule |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Blood Glucose Concentration | Maximum post-prandial blood glucose concentration (Cmax) during the 120-minute test period. | 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of the breakfast with each capsule |
| Total area under the curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco A Tomás-Barberán, PhD | CEBAS-CSIC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Católica de San Antonio (UCAM) | Murcia | 30107 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33605836 | Background | Lira Neto JCG, Damasceno MMC, Ciol MA, de Freitas RWJF, de Araujo MFM, Teixeira CRS, Carvalho GCN, Lisboa KWSC, Marques RLL, Alencar AMPG, Zanetti ML. Efficacy of Cinnamon as an Adjuvant in Reducing the Glycemic Biomarkers of Type 2 Diabetes Mellitus: A Three-Month, Randomized, Triple-Blind, Placebo-Controlled Clinical Trial. J Am Nutr Assoc. 2022 Mar-Apr;41(3):266-274. doi: 10.1080/07315724.2021.1878967. Epub 2021 Feb 19. | |
| 27618575 |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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This was a crossover interventional study conducted with 21 volunteers. Volunteers were randomly assigned to receive either the treatment or the placebo twice each. Each participant received both the treatment and the placebo in a sequential manner, with a washout period of two or three days between interventions.
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| Capsules with active ingredients |
| Dietary Supplement |
Capsules with phloretin rich apple extract, magnesium oxide, cinnamon extract, zinc citrate and chromium picolinate |
|
| Placebo Repetition | Dietary Supplement | Repetition of the placebo (capsules with microcrystalline cellulose 102) intake |
|
| Capsules with active ingredients Repetition | Dietary Supplement | Repetition of the supplement intake (Capsules with phloretin rich apple extract, magnesium oxide, cinnamon extract, zinc citrate and chromium picolinate) |
|
Glucose concentration across the 120-minute test period (values down to baseline levels). |
| 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of the breakfast with each capsule |
| Blood Glucose Concentration at different times | Blood glucose concentration at different times post-ingestion | 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of the breakfast with each capsule |
| Time to peak concentration for glucose | Time (min) when Cmax of glucose is reached | 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption the breakfast with each capsule. |
| Background |
| Costello RB, Dwyer JT, Saldanha L, Bailey RL, Merkel J, Wambogo E. Do Cinnamon Supplements Have a Role in Glycemic Control in Type 2 Diabetes? A Narrative Review. J Acad Nutr Diet. 2016 Nov;116(11):1794-1802. doi: 10.1016/j.jand.2016.07.015. Epub 2016 Sep 8. |
| 30889804 | Background | Kostov K. Effects of Magnesium Deficiency on Mechanisms of Insulin Resistance in Type 2 Diabetes: Focusing on the Processes of Insulin Secretion and Signaling. Int J Mol Sci. 2019 Mar 18;20(6):1351. doi: 10.3390/ijms20061351. |
| 35565682 | Background | Pelczynska M, Moszak M, Bogdanski P. The Role of Magnesium in the Pathogenesis of Metabolic Disorders. Nutrients. 2022 Apr 20;14(9):1714. doi: 10.3390/nu14091714. |
| 39923147 | Background | Ul Hasnain SZ, Ahmed M, Manzoor R, Amin A, Mudassir J, Jafar Rana S, Abbas K. Anti-inflammatory, antidiabetic and hypolipidemic potential of Cinnamomum verum J. Presi bark coupled with FT-IR and HPLC analysis. Pak J Pharm Sci. 2024 Nov-Dec;37(6):1529-1544. |
| 33783683 | Background | Zhao F, Pan D, Wang N, Xia H, Zhang H, Wang S, Sun G. Effect of Chromium Supplementation on Blood Glucose and Lipid Levels in Patients with Type 2 Diabetes Mellitus: a Systematic Review and Meta-analysis. Biol Trace Elem Res. 2022 Feb;200(2):516-525. doi: 10.1007/s12011-021-02693-3. Epub 2021 Mar 30. |
| 39541030 | Background | Georgaki MN, Tsokkou S, Keramas A, Papamitsou T, Karachrysafi S, Kazakis N. Chromium supplementation and type 2 diabetes mellitus: an extensive systematic review. Environ Geochem Health. 2024 Nov 14;46(12):515. doi: 10.1007/s10653-024-02297-5. |
| 40613623 | Background | Derosa G, Maffioli P, D'Angelo A, Foscaldi V, Piazza R, Mangrella M, Fogacci F, Cicero AFG. Exploring nutraceutical solutions for prediabetes: a narrative review on the effects of banaba and chromium picolinate. Eur Rev Med Pharmacol Sci. 2025 Jun;29(6):324-338. doi: 10.26355/eurrev_202506_37275. |
| 36079895 | Background | Nakhate KT, Badwaik H, Choudhary R, Sakure K, Agrawal YO, Sharma C, Ojha S, Goyal SN. Therapeutic Potential and Pharmaceutical Development of a Multitargeted Flavonoid Phloretin. Nutrients. 2022 Sep 2;14(17):3638. doi: 10.3390/nu14173638. |
| D004700 | Endocrine System Diseases |