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PrediabetesALPHANUTRINCT07265115

Preventive Nutritional Supplements for Preclinical Pathologies

A study testing Capsules with active ingredients and Capsules with active ingredients Repetition in people with Prediabetes, run by Centro de Edafología y Biología Aplicada del Segura at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 with a risk of developing impaired fasting glucose. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Prediabetes
What is being tested?
Capsules with active ingredients and Capsules with active ingredients Repetition
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteSpain
Study dates
1 Dec 2025to 10 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fasting blood glucose values between 100 and 120 mg/dL
  • To be habitual breakfast consumers

Who cannot join

  • To have diabetes medication during the study
  • To have antibiotics during the study
  • To be pregnant or in lactating period

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad Católica de San Antonio (UCAM)

    Murcia, 30107

Other trials in Spain

About this study

Official title: 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 with a risk of developing impaired fasting glucose.

Read the detailed description

An interventional study was conducted in collaboration with the Catholic University of San Antonio Murcia (UCAM). A total of 21 volunteers (fasting blood glucose levels >100 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.

Conditions
Prediabetes
Being tested
Placebo, Capsules with active ingredients, Placebo Repetition, Capsules with active ingredients Repetition
Keywords
Prediabetes, Natural product, Bioactive compounds, Postprandial glycemia
Medical subject headings
Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    Capsules with microcrystalline cellulose 102

  • Capsules with active ingredientsDietary supplement

    Capsules with phloretin rich apple extract, magnesium oxide, cinnamon extract, zinc citrate and chromium picolinate

  • Placebo RepetitionDietary supplement

    Repetition of the placebo (capsules with microcrystalline cellulose 102) intake

  • Capsules with active ingredients RepetitionDietary supplement

    Repetition of the supplement intake (Capsules with phloretin rich apple extract, magnesium oxide, cinnamon extract, zinc citrate and chromium picolinate)

Study groups in NCT07265115
Study groupRoleWhat they receive
Placebo capsulePlacebo comparatorParticipants receive a matching placebo during their assigned period.
Receives: Dietary Supplement: Placebo
Active CapsulesExperimentalParticipants receive the supplement during their assigned period.
Receives: Dietary Supplement: Capsules with active ingredients
Placebo capsule (repetition)Placebo comparatorThis arm was a repetition of the placebo intake
Receives: Dietary Supplement: Placebo Repetition
Active capsules (repetition)ExperimentalThis arm was a repetition of the supplement intake
Receives: Dietary Supplement: Capsules with active ingredients Repetition

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Capillary blood glucose was monitored using a glucometer

    Measured: 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes and 120 minutes following the consumption of breakfast with each capsule

Secondary outcomes (4)

  1. Peak Blood Glucose Concentration

    Maximum post-prandial blood glucose concentration (Cmax) during the 120-minute test period.

    Measured: 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of the breakfast with each capsule

  2. Total area under the curve (AUC)

    Glucose concentration across the 120-minute test period (values down to baseline levels).

    Measured: 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of the breakfast with each capsule

  3. Blood Glucose Concentration at different times

    Blood glucose concentration at different times post-ingestion

    Measured: 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of the breakfast with each capsule

  4. Time to peak concentration for glucose

    Time (min) when Cmax of glucose is reached

    Measured: 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption the breakfast with each capsule.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2025
  2. Study start1 Dec 2025
  3. Primary completion10 Feb 2026
  4. Study completion10 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07265115
Sponsor's protocol ID
CE042501
Acronym
ALPHANUTRI
Status last verified
Oct 2026
First submitted
24 Nov 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33605836

  • 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.

    PubMed 27618575

  • 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.

    PubMed 30889804

  • 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.

    PubMed 35565682

  • 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.

    PubMed 39923147

  • 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.

    PubMed 33783683

  • 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.

    PubMed 39541030

  • 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.

    PubMed 40613623

  • 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.

    PubMed 36079895

Questions about this trial

What is this clinical trial studying?

A study testing Capsules with active ingredients and Capsules with active ingredients Repetition in people with Prediabetes, run by Centro de Edafología y Biología Aplicada del Segura at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incremental Area Under the Curve (iAUC) of blood glucose over 120 minutes (time frame: 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes and 120 minutes following the consumption of breakfast with each capsule). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07265115, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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