Preventive Nutritional Supplements for Preclinical Pathologies

NCT07265115 | Completed

• 1 other identifier: CE042501
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetes

Keywords

Prediabetes; Natural product; Bioactive compounds; Postprandial glycemia

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (4)

• 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

• 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

• 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

• 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.

Study Arms (4)

Placebo capsule

PLACEBO COMPARATOR

Participants receive a matching placebo during their assigned period.

Dietary Supplement: Placebo

Active Capsules

EXPERIMENTAL

Participants receive the supplement during their assigned period.

Dietary Supplement: Capsules with active ingredients

Placebo capsule (repetition)

PLACEBO COMPARATOR

This arm was a repetition of the placebo intake

Dietary Supplement: Placebo Repetition

Active capsules (repetition)

EXPERIMENTAL

This arm was a repetition of the supplement intake

Dietary Supplement: Capsules with active ingredients Repetition

Interventions

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)

Active capsules (repetition)

Placebo DIETARY_SUPPLEMENT

Capsules with microcrystalline cellulose 102

Placebo capsule

Capsules with active ingredients DIETARY_SUPPLEMENT

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

Active Capsules

Placebo Repetition DIETARY_SUPPLEMENT

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

Placebo capsule (repetition)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centro de Edafología y Biología Aplicada del Segura: lead
• San Antonio Technologies - San Antonio Catholic University of Murcia: collaborator

Study Sites (1)

Universidad Católica de San Antonio (UCAM)

Murcia, 30107, Spain

Location

Related Publications (9)

• 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.

  PMID: 33605836 BACKGROUND

• 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.

  PMID: 27618575 BACKGROUND

• 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.

  PMID: 30889804 BACKGROUND

• 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.

  PMID: 35565682 BACKGROUND

• 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.

  PMID: 39923147 BACKGROUND

• 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.

  PMID: 33783683 BACKGROUND

• 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.

  PMID: 39541030 BACKGROUND

• 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.

  PMID: 40613623 BACKGROUND

• 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.

  PMID: 36079895 BACKGROUND

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Francisco A Tomás-Barberán, PhD

  CEBAS-CSIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: 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.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: January 12, 2026
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)