NCT05926947

Brief Summary

The aim of this study is to develop a proof of concept establishing a causal relationship between glycemia improvement through combination of polyphenols-rich botanical extracts or polyphenols-rich botanical extracts associated with white kidney bean extract and chromimum picolinate + zinc bisglycinate with chronic supplementation. Chronic glycemia improvement will be assessed by following the evolution of HbA1c, postprandial glucose and insulin kinetics, and questionnaires. The study design is double blinded randomized with 3 arms and 29 volunteers per arm.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

July 5, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

April 20, 2023

Last Update Submit

September 12, 2025

Conditions

Prediabetic StateOverweight

Outcome Measures

Primary Outcomes (3)

  • HbA1c

    Evaluation of changes in the glycated haemoglobin measurements in comparison of the 3 groups

    12 weeks

  • Post prandial glycemia

    Evaluation of changes in acute and chronic glycemia: Changes in the postprandial glucose measurements in comparison of the 3 groups after the standardized breakfast at baseline, 4th, 8th and 12th week.

    12 weeks

  • Post prandial insulemia

    Evaluation of changes in acute glycemia: Change in postprandial insulin in comparison of the 3 groups after the standardized breakfast at baseline, 4th, 8th and 12th week.

    12 weeks

Secondary Outcomes (4)

  • Body weight

    12 weeks

  • Dual-energy X-ray (DEXA)

    12 weeks

  • Magnetic resonance imaging (MRI)

    12 weeks

  • Short Form 12 (SF-12) questionnaire

    12 weeks

Study Arms (3)

Verum A

EXPERIMENTAL
Dietary Supplement: Verum A

Verum B

EXPERIMENTAL
Dietary Supplement: Verum B

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Verum ADIETARY_SUPPLEMENT

Formulation of polyphenols from olive leaf extract, blackcurrant extract, pomegranate extract, grapefruit extract

Verum A
Verum BDIETARY_SUPPLEMENT

Formulation of polyphenols from olive leaf extract, blackcurrant extract, white kidney bean extract, chromium picolinate and Zinc bisglycinate

Verum B
PlaceboDIETARY_SUPPLEMENT

Micro crystalline cellulose

Placebo

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Fasting Plasma Glucose 75 - 125 mg/dL
  • HbA1c: 5.-6.5 %
  • Both sexes
  • Overweight BMI range (25-30 Kg/m2)
  • Age: 20-50 years old

You may not qualify if:

  • Metabolic/Chronical disease
  • Menopausal women
  • Being pregnant, breastfeeding or wanting to have a baby
  • Former obese with a history of yoyo effect
  • Have been involved in a weight loss program in the past 12 months or subjected to weight reduction surgery
  • Having started or quit smoking, having a high alcohol consumption
  • Have in the past been in a long-term antibiotherapy (1 month or more) and/or a regular antibiotherapy in the past 12 months
  • Allergy to olive, blackcurrant, pomegranate, grapefruit, white kidney bean, or corn.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCAM Universidad Católica San Antonio de Murcia

Guadalupe, Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Prediabetic StateOverweight

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pedro Alcaraz

    UCAM (Universidad Catolica San Antonio de Murcia)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Double blind randomized parallel study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2023

First Posted

July 3, 2023

Study Start

July 5, 2023

Primary Completion

October 30, 2025

Study Completion

December 15, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations

ES(1)