Glycaemia management using botanical extracts and supplements
Evaluation of Two Plant Formulations for the Management of Glycemia on Pre-diabetic Participants
NA · Fytexia · NCT05926947
This study is testing if taking certain plant extracts and supplements can help people with high blood sugar levels manage their condition better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 87 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | All |
| Sponsor | Fytexia (industry) |
| Locations | 1 site (Guadalupe, Murcia) |
| Trial ID | NCT05926947 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a causal relationship between glycemia improvement and the chronic supplementation of polyphenol-rich botanical extracts, white kidney bean extract, chromium picolinate, and zinc bisglycinate. It employs a double-blind, randomized design with three arms, involving 29 volunteers in each arm. The effectiveness of the interventions will be assessed by monitoring changes in HbA1c levels, postprandial glucose, insulin kinetics, and participant questionnaires over the study duration.
Who should consider this trial
Good fit: Ideal candidates are overweight individuals aged 20-50 with fasting plasma glucose levels between 75-125 mg/dL and HbA1c levels between 5-6.5%.
Not a fit: Patients with metabolic or chronic diseases, menopausal women, or those with a history of obesity and weight loss interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel approach to managing glycemia in prediabetic and overweight individuals.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in glycemia management using botanical extracts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Guadalupe, Murcia
- UCAM Universidad Católica San Antonio de Murcia — Guadalupe, Murcia, Spain (RECRUITING)
Study contacts
- Principal investigator: Pedro Alcaraz — UCAM (Universidad Catolica San Antonio de Murcia)
- Study coordinator: Julien Cases
- Email: jcases@fytexia.com
- Phone: +33 467219098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prediabetic State, Overweight