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New treatment option for Prediabetes
Official title Effect of a Nutritional Product Containing Carob Extract on Carbohydrate Metabolism in Glucose-intolerant Subjects
ClinicalTrials.gov ID: NCT07420998
What this study is testing
- What it's testing
- Randomized, controlled, double-blind clinical trial with two parallel arms based on the product consumed (experimental product and placebo product) and conducted at a single center, to measure the efficacy of the liquid NUTIFOOD product (nutritional product with carob extract) on carbohydrate metabolism.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- people of both sexes aged 18-65 years.
- Diagnosis of glucose intolerance according to the American Diabetes Association (at least one of the following criteria):
- Impaired fasting glucose (100-125 mg/dl)
- Impaired glucose tolerance (oral glucose tolerance test with 2-hour plasma glucose between 140-199 mg/dl)
- Glycated hemoglobin between 5.7% and 6.4%
You likely can't join if
- Use of medications that may interfere with glucose metabolism.
- people with a history of any type of hepatic or renal disease.
- Alcohol consumption greater than 20 g/day.
- History of allergic hypersensitivity or poor tolerance to any component of the study products.
- Participation in another clinical trial within the three months prior to the study.
- Lack of willingness or inability to comply with clinical trial procedures.
See the full eligibility criteria
- people of both sexes aged 18-65 years.
- Diagnosis of glucose intolerance according to the American Diabetes Association (at least one of the following criteria):
- Impaired fasting glucose (100-125 mg/dl)
- Impaired glucose tolerance (oral glucose tolerance test with 2-hour plasma glucose between 140-199 mg/dl)
- Glycated hemoglobin between 5.7% and 6.4%
- Body mass index between 20-35 kg/m².
- Stable dietary habits: no weight gain or loss greater than 5 kg in the last ten weeks.
- Volunteers capable of understanding the clinical study and willing to comply with the study procedures and requirements.
- Use of medications that may interfere with glucose metabolism.
- people with a history of any type of hepatic or renal disease.
- Alcohol consumption greater than 20 g/day.
- History of allergic hypersensitivity or poor tolerance to any component of the study products.
- Participation in another clinical trial within the three months prior to the study.
- Lack of willingness or inability to comply with clinical trial procedures.
- Pregnant or breastfeeding women.
The study team makes the final eligibility decision.
Where it's taking place
- Murcia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Murcia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.