RecruitingNot ApplicableNCT07420998

Effect of a Nutritional Product Containing Carob Extract on Carbohydrate Metabolism in Glucose-intolerant Subjects

Randomized Clinical Trial on the Effect of a Nutritional Product Containing Carob Extract (NUTIFOOD) on Carbohydrate Metabolism in Glucose-intolerant Subjects


Sponsor

Universidad Católica San Antonio de Murcia

Enrollment

30 participants

Start Date

Jan 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

  • Subjects 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.

Exclusion Criteria7

  • Use of medications that may interfere with glucose metabolism.
  • Subjects 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.

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Interventions

DIETARY_SUPPLEMENTExperimental Product

Participants will consume two doses per day. The product should be taken 30 minutes before the two main meals of the day.

DIETARY_SUPPLEMENTControl product

Participants will consume two daily doses of the placebo product. The product should be taken 30 minutes before the two main meals of the day.


Locations(1)

UCAM HiTech, Sport & Health Innovation Hub

Murcia, Spain

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NCT07420998


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