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Evaluation of the effectiveness and cost-effectiveness of functional foods in glycemic control

Evaluation of the effectiveness and cost-effectiveness of two foods drugs enriched with prebiotics in the glycemic control of adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9qmspht
Enrollment
Unknown
Registered
2021-07-01
Start date
2020-10-08
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cost-Efficiency Analysis

Interventions

Participants will receive the food formulation according to the group they are allocated to, Formula 1 (6 grams of Arabica Coffee (100%) + 250mg Cocoa (100%) + 3 grams of Fructo-oligosaccharides) n=40
SP2.006.042
G07.203.300.456

Sponsors

Fundação Osvaldo Cruz
Lead Sponsor
Universidade da Integração Internacional da Lusofonia Afro-Brasileira
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Be aged 18-80 years; Any gender; Mini-examination of mental status = 27 points; = 22 points (person with 1-11 years of study) and = 9 points (illiterate person);Have no allergy to products from cocoa, coffee and / or FOS

Exclusion criteria

Exclusion criteria: Being a chronic user of glucocorticoid and / or psychotropic drugs;Being affected by diabetes;Being pregnant or breastfeeding;Being a woman with a history of osteoporosis;Have undergone less than 30 days of surgical treatment;Being a smoker

Design outcomes

Primary

MeasureTime frame
It is expected that after 10 weeks, with the use of coffee (6g) enriched with cocoa (250mg) and fructo-oligosaccharide (3g) the measurement of glycated hemoglobin analyzed using the chromatography method will show a reduction of 0.5% in the Formulation 1 group (caffeinated coffee)

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactMárcio Moura de Araújo
oicam29@gmail.com+55 085 98628-1982

Outcome results

None listed

Source: REBEC (via WHO ICTRP)