NCT07265115

Preventive Nutritional Supplements for Preclinical Pathologies

Advanced Preventive Nutritional Supplements Targeting Pathologies in the Preclinical Phase

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Centro de Edafología y Biología Aplicada del Segura · Other Government
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this intervention study was to evaluate the functionality of a multi-target preparation (rich in dihydrochalcones 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. 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.

Conditions

• Prediabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Capsules with microcrystalline cellulose 102
DIETARY_SUPPLEMENT	Capsules with active ingredients	Capsules with phloretin rich apple extract, magnesium oxide, cinnamon extract, zinc citrate and chromium picolinate
DIETARY_SUPPLEMENT	Placebo Repetition	Repetition of the placebo (capsules with microcrystalline cellulose 102) intake
DIETARY_SUPPLEMENT	Capsules with active ingredients Repetition	Repetition of the supplement intake (Capsules with phloretin rich apple extract, magnesium oxide, cinnamon extract, zinc citrate and chromium picolinate)

Timeline

• Start date: 2025-06-02
• Primary completion: 2025-10-07
• Completion: 2025-10-07
• First posted: 2025-12-04
• Last updated: 2025-12-12

Locations

1 site across 1 country: Spain