Prediabetes
Conditions
Keywords
Prediabetes, Natural product, Bioactive compounds, Postprandial glycemia
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Capsules with microcrystalline cellulose 102
DIETARY_SUPPLEMENTCapsules with active ingredients
Capsules with phloretin rich apple extract, magnesium oxide, cinnamon extract, zinc citrate and chromium picolinate
DIETARY_SUPPLEMENTPlacebo Repetition
Repetition of the placebo (capsules with microcrystalline cellulose 102) intake
DIETARY_SUPPLEMENTCapsules with active ingredients Repetition
Repetition of the supplement intake (Capsules with phloretin rich apple extract, magnesium oxide, cinnamon extract, zinc citrate and chromium picolinate)
Sponsors
Centro de Edafología y Biología Aplicada del Segura
San Antonio Technologies - San Antonio Catholic University of Murcia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fasting blood glucose values between 100 and 120 mg/dL * To be habitual breakfast consumers
Exclusion criteria
* To have diabetes medication during the study * To have antibiotics during the study * To be pregnant or in lactating period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incremental Area Under the Curve (iAUC) of blood glucose over 120 minutes | 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of breakfast with each capsule | Capillary blood glucose was monitored using a glucometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Blood Glucose Concentration | 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of the breakfast with each capsule | Maximum post-prandial blood glucose concentration (Cmax) during the 120-minute test period. |
| Total area under the curve (AUC) | 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of the breakfast with each capsule | Glucose concentration across the 120-minute test period (values down to baseline levels). |
| Blood Glucose Concentration at different times | 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 post-ingestion |
| Time to peak concentration for glucose | 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption the breakfast with each capsule. | Time (min) when Cmax of glucose is reached |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORFrancisco A Tomás-Barberán, PhD
CEBAS-CSIC
Outcome results
None listed