Efeito de bebida rica em fibra na redução da glicemia de diabéticos

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-2xxp48
• Date of registration: 26/09/2011
• Primary sponsor: Universidade Federal de Goiás - Brazil
• Public title: Efeito de bebida rica em fibra na redução da glicemia de diabéticos
• Scientific title: Effect of juice diet enriched with soluble fiber in reducing blood glucose of patients with diabetes mellitus type 2
• Date of first enrolment: 01/07/2010
• Target sample size: 30
• Recruitment status: recruitment completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-2xxp48/
• Study design: Clinical trial randomized; of two arms, double-blind.

Countries of recruitment

Brazil

Contacts

• Name: Ana Clara Carvalho
• Affiliation: Ana Clara Martins e Silva Carvalho

• Name: Ana Clara Carvalho
• Affiliation: Ana Clara Martins e Silva Carvalho

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria are: to be with diabetes mellitus type 2, has a body mass index above 25 kg/m2 and waist circumference increased, being sedentary, belong to the age group between 30 and 59 years and sign the Informed Consent Informed Consent (IC).
Exclusion criteria: The exclusion criteria are: patients who are taking insulin, with chronic complications of diabetes, gastrointestinal disorders and intolerance fibers, pregnant and lactating women, and those who do not complete the follow-up during the study period.

Age minimum: 30
Age maximum: 60
Gender: -

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2
C18.452.394.750.149

Intervention(s)

The experimental group will receive sachets for the preparation of a portion of drink per day (each serving equals 1 cup of drink 200 ml prepared), total consumption of 9 g of soluble fiber coming from the consumption of one serving of drink per day. The control group will receive sachets for the preparation of a portion of drink per day (each serving equals 1 cup of drink 200 ml prepared), but this addition of drink contains no fiber. Both groups should consume one sachet per day, 30 minutes before lunch for 3 months.

Primary Outcome(s)

Reduction of glycated hemoglobin, HOMA B and HOMA IR, over the 3 months of intervention compared to baseline.
Glycated hemoglobin should be between 7.0 and 6.5%. HOMA B should be between 167 and 175% and the HOMA IR index lower than 3.4.

Secondary Outcome(s)

Reduced levels of cholesterol and triglycerides, over the 3 months of intervention compared to baseline.
Cholesterol and triglycerides should be below 200 and 150 mg respectively.

Secondary ID(s)

130/10

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de Goiás - FAPEG - Brazil

Secondary Sponsor(s)

Ana Clara Martins e Silva Carvalho - Brazil