Overweight, Prediabetic State
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVerum A
Formulation of polyphenols from olive leaf extract, blackcurrant extract, pomegranate extract, grapefruit extract
DIETARY_SUPPLEMENTVerum B
Formulation of polyphenols from olive leaf extract, blackcurrant extract, white kidney bean extract, chromium picolinate and Zinc bisglycinate
DIETARY_SUPPLEMENTPlacebo
Micro crystalline cellulose
Sponsors
Fytexia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double blind randomized parallel study
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 12 weeks | Evaluation of changes in the glycated haemoglobin measurements in comparison of the 3 groups |
| Post prandial glycemia | 12 weeks | 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. |
| Post prandial insulemia | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 12 weeks | Change in the body weight measurements in comparison of the 3 groups |
| Short Form 12 (SF-12) questionnaire | 12 weeks | Evaluation of changes in responses to SF-12 questionnaire. SF-12 questionnaire is a health related questionnaire with 12 questions. The total score range from 0-100, with higher score indicating better health status. |
| Dual-energy X-ray (DEXA) | 12 weeks | Evaluation of changes in fat mass and lean mass using a Dual-energy X-ray absorptiometry and compare amongst 3 groups |
| Magnetic resonance imaging (MRI) | 12 weeks | Evaluation of changes in various fat layers (visceral, subcutaneous and deep subcutaneous) using a MRI and compare amongst 3 groups |
Countries
Spain
Outcome results
None listed