Preventive Nutritional Supplements for Preclinical Pathologies (ALPHANUTRI)

Centro de Edafología y Biología Aplicada del Segura

Status: Completed

Conditions: Prediabetes

Treatments: Dietary Supplement: Capsules with active ingredients; Dietary Supplement: Capsules with active ingredients Repetition; Dietary Supplement: Placebo Repetition; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07265115

CE042501

Details and patient eligibility

About

The main objective of this intervention study was to evaluate the functionality of a multi-target preparation (rich in dihydrochalcones from apple, chromium picolinate, zinc, magnesium and cinnamon extract) on the glucose response of individuals who show factors associated with prediabetes.

Full description

An interventional study was conducted in collaboration with the Catholic University of San Antonio Murcia (UCAM). A total of 21 prediabetic volunteers (fasting blood glucose levels between 100 and 120 mg/dL) who were not taking diabetes medication or antibiotics during the study were recruited.

The participants were invited to an information session to learn more about the study objectives and procedures, and they signed informed consent forms. During this first visit, anthropometric measurements were taken, and a questionnaire was administered to gather information about their diet and physical activity. Each volunteer made four more visits to the UCAM facilities. On each visit, the volunteers ingested either a placebo capsule or the formulated dietary supplement, followed by a standard breakfast consisting of three toasted bread slices and two single-serving packets of strawberry or peach jam (resulting in a total carbohydrate intake of 49.5 g). The volunteers were randomly assigned to receive the placebo or the supplemet and each of them was taken twice. At time 0 and at different times after breakfast intake (15, 30, 45, 60, 75, 90, 105 and 120 min) blood glucose was measured using capillary blood sample obtained by finger prick and a glucometer.

Enrollment: 21 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fasting blood glucose values between 100 and 120 mg/dL
• To be habitual breakfast consumers

Exclusion criteria

• To have diabetes medication during the study
• To have antibiotics during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants receive a matching placebo during their assigned period.

Treatment:

Dietary Supplement: Placebo

Capsules with active ingredients

Experimental group

Description:

Participants receive the supplement during their assigned period.

Treatment:

Dietary Supplement: Capsules with active ingredients

Placebo Repetition

Placebo Comparator group

Description:

This arm was a repetition of the placebo intake

Treatment:

Dietary Supplement: Placebo Repetition

Capsules with active ingredients Repetition

Experimental group

Description:

This arm was a repetition of the supplement intake

Treatment:

Dietary Supplement: Capsules with active ingredients Repetition