Gummy Candies With Maqui Berry

NCT07373795 | Completed DMC

• 2 other identifiers: DIUV-CIDI 15/2024100-InES/Lánzate-UV 2022
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if Maqui berry gummy encapsulated (GMM) compared to non-encapsulated (GM) can improve glycemic response in overweight adults. It will also learn about the possible effect of serum antioxidant levels. The main questions it aims to answer are: Does GMM or GM low the glycemic response in overweight/obese subjects after consuming a carbohydrate rich food? Does GMM or GM increase antioxidant levels in overweight/obese subjects after consuming a carbohydrate rich food? Researchers will compare (i) a carbohydrate rich food, (ii) GMM + a carbohydrate rich food, (iii) GM + a carbohydrate rich food to see if Maqui gummy work to control glycemic and antioxidant levels. Participants will: Take a carbohydrate rich food, and/or Maqui gummy three times, one week apart Have blood samples collected and answer food questionnaires in each visit

Conditions

Overweight (BMI > 25); Obesity & Overweight; Insulin Resistance Syndrome; Type 2 Diabetes

Keywords

Maqui berry; GLP-1; Polyphenols; glycemic control; Antioxidant response; SOD; Catalase; TRAP

Outcome Measures

Primary Outcomes (1)

• Glycemia

  Blood capillary samples were obtained from participants' fingers using glucose test strips (One Touch II) before consuming the white bread (time 0) and after consumption with or without the GCs (at 15, 30, 60, 90 and 120 minutes). It will be expressed as mg/dl.

  Blood capillary samples will be obtained from participant's finger using glucose test strips (One Touch II) before consuming the white bread (time 0) and after consumption with or without the GCs (at 15, 30, 60, 90 and 120 minutes).

Secondary Outcomes (8)

• Insulin levels

  Blood samples will be obtained for insulin concentrations at time points 0 and 120 minutes that will be measured using a chemiluminescence immunoassay according manufacturer's recommendations.

• GLP-1

  Human plasma levels of GLP-1 will be measured at 0 and 120 minutes.

• Total Reactive Antioxidant Power (TRAP)

  Antioxidant biomarkers will be measured at 0 and 120 minutes after each intervention

• Total protein measurement

  Antioxidant biomarkers will be measured at 0 and 120 minutes after each intervention

• Superoxide dismutase (SOD)

  Antioxidant biomarkers will be measured at 0 and 120 minutes after each intervention

Other Outcomes (1)

• IMC

  At the beginning

Study Arms (1)

Control, GM, GMM

OTHER

Participants will complete a three-condition, within-subject acute intervention with one-week washouts between visits: (i) baseline/control: 150 g white bread (75 g available carbohydrate);(ii) white bread + GM: 150 g white bread plus 24 g GM (3 gummies); (iii) white bread + GMM: 150 g white bread plus 24 g GMM (3 gummies). Each participant will serve as their own control. On each study day (control, GM, GMM), a fasting baseline sample (time 0) will drawn before ingestion of the test meal. Visits will occur on separate days, one week apart, under standardized pre-test conditions (overnight fast, fixed morning schedule, and pre specified diet/activity restrictions).

Dietary Supplement: GM; Dietary Supplement: Control; Dietary Supplement: GMM

Interventions

GM DIETARY_SUPPLEMENT

white bread + GM: 150 g white bread plus 24 g GM (3 gummies)

Control, GM, GMM

Control DIETARY_SUPPLEMENT

Baseline/control: 150 g white bread (75 g available carbohydrate)

Control, GM, GMM

GMM DIETARY_SUPPLEMENT

white bread + GM: 150 g white bread plus 24 g GM (3 gummies)

Control, GM, GMM

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) of overweight or obesity (BMI at least 25.0 kg/m2);
• absence of non-communicable chronic disease;
• being sedentary (less than 30 minutes of physical activity for 3 times a week).
• All participants must maintain their physical activity, food intake and medications during the whole study.

You may not qualify if:

• use of hypoglycemic drugs
• supplements containing antioxidants
• high consumption of polyphenols (more than 2 g per day)
• food allergy to Maqui berry or any component from the GCs
• pregnancy or lactation in the case of the female participants

Sponsors & Collaborators

• Gonzalo Jorquera, PhD: lead
• Universidad de Valparaiso: collaborator

Study Sites (1)

Faculty of Pharmacy

Valparaíso, Región de Valparaíso, 2340000, Chile

Location

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Model Details: Intervention Participants will complete a three-condition, within-subject acute intervention with one-week washouts between visits: (i) baseline/control: 150 g white bread (75 g available carbohydrate); (ii) white bread + GM: 150 g white bread plus 24 g GM (3 gummies); and (iii) white bread + GMM: 150 g white bread plus 24 g GMM (3 gummies). Each participant will serve as their own control. On each study day (control, GM, GMM), a fasting baseline sample (time 0) will drawn before ingestion of the test meal. Visits will occur on separate days, one week apart, under standardized pre-test conditions (overnight fast, fixed morning schedule, and pre specified diet/activity restrictions).

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 28, 2026
• Study Start: December 2, 2025
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CL (1)