Preventive Nutritional Supplements for Preclinical Pathologies (ALPHANUTRI)

April 23, 2026 updated by: María-Teresa García-Conesa, Centro de Edafología y Biología Aplicada del Segura

Advanced Preventive Nutritional Supplements Targeting Pathologies in the Preclinical Phase

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30107
        • Universidad Católica de San Antonio (UCAM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo capsule
Participants receive a matching placebo during their assigned period.
Dietary supplement: Placebo
Capsules with microcrystalline cellulose 102
Experimental: Active Capsules
Participants receive the supplement during their assigned period.
Dietary supplement: Capsules with active ingredients
Capsules with phloretin rich apple extract, magnesium oxide, cinnamon extract, zinc citrate and chromium picolinate
Placebo Comparator: Placebo capsule (repetition)
This arm was a repetition of the placebo intake
Dietary supplement: Placebo Repetition
Repetition of the placebo (capsules with microcrystalline cellulose 102) intake
Experimental: Active capsules (repetition)
This arm was a repetition of the supplement 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of breakfast with each capsule

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
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 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
0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption the breakfast with each capsule.
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).
0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of the breakfast with each capsule

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Edafología y Biología Aplicada del Segura

Collaborators

San Antonio Technologies - San Antonio Catholic University of Murcia

Investigators

  • Principal Investigator: Francisco A Tomás-Barberán, PhD, CEBAS-CSIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2026

Primary Completion (Actual)

February 10, 2026

Study Completion (Actual)

February 10, 2026

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

December 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE042501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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