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Completed

NCT Number: NCT07265115

Preventive Nutritional Supplements for Preclinical Pathologies

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica de San Antonio (UCAM)

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

Capsules with microcrystalline cellulose 102

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)

Primary outcomes

  1. Incremental Area Under the Curve (iAUC) of blood glucose over 120 minutes

    Time frame: 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 outcomes

  1. Peak Blood Glucose Concentration

    Time frame: 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.

  2. Total area under the curve (AUC)

    Time frame: 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).

  3. Blood Glucose Concentration at different times

    Time frame: 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

  4. Time to peak concentration for glucose

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centro de Edafología y Biología Aplicada del Segura

Other Gov

Collaborators

  • San Antonio Technologies - San Antonio Catholic University of Murcia

Registry information

Official study title

Advanced Preventive Nutritional Supplements Targeting Pathologies in the Preclinical Phase

Acronym: ALPHANUTRI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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