Investigation of the effect of the consumption of the soluble fiber on the serum cholesterol levels and fractions in children and adolescents.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-5fybg2
• Date of registration: 31/01/2012
• Primary sponsor: Laboratório de Erros Inatos do Metabolismo- Universidade Federal do Pará - Brazil
• Public title: Investigation of the effect of the consumption of the soluble fiber on the serum cholesterol levels and fractions in children and adolescents.
• Scientific title: Investigation of the effect of psyllium in the process of atherosclerosis juvenile
• Date of first enrolment: 01/08/2010
• Target sample size: 100
• Recruitment status: data analysis completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-5fybg2/
• Study design: Randomised, parallel, double-blind clinical trial,arms two.

Countries of recruitment

Brazil

Contacts

• Name: simone ribas
• Affiliation: Universidade do Estado do Rio de Janeiro- UERJ

• Name: Luiz Santana da Silva
• Affiliation: Laboratório de Erros Inatos do Metabolismo- Universidade Federal do Pará

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: Children and adolescents (6-19 years) that had a fasting plasma total cholesterol over 170mg/dL (4,40 mmol/L) or LDL-cholesterol over 110mg/dL (2,84 mmol/dL) concentrations, same after were treated initially with similar diet the National Cholesterol Education Program step 1 diet (saturated low-fat diet (<10% calories total) and cholesterol (< 300 mg/dia), for at least eight weeks. The subjects were all outpatients of the Pediatric Nutrition Division and Adolescent Health Studies Nucleus of the Pedro Ernesto University Hospital in Rio de Janeiro, and only those subjects that signed an Informed Consent Form could participated the study.
Exclusion criteria: Patients with cardiovascular diseases or or other chronic medical conditions were excluded from the study, as were those whose diabetes.
Children and adolescents with triacylglycerol concentrations of over 3.39 mmol/L or whose Body Mass Index (BMI) according age was higher than 30 kg/m² or female pregnant were also excluded.
Participants were taking lipid-lowering agents, including hypolipemiant functional foods were also excluded the study.


Age minimum: 6Y
Age maximum: 19Y
Gender: -

Health Condition(s) or Problem(s) studied

Dyslipidemia (elevated cholesterol total or high LDL- cholesterol)
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Intervention(s)

Initially,all recruited participants went through a phase of adaptation to a diet restricted in saturated fat(<7%) and cholesterol (<200mg/day) for 6-week to prior to the treatment phase. After this period, all eligible (n=60)participants were allocated randomly to two groups (control( n=30) and psyllium (n=30)) using a computer-generated random number sequence. Then, over an eight-weeks , participants in the group (psyllium)maintained a diet low in saturated fat and cholesterol, but now supplemented daily with 7.0g of psyllium, while the control group received the same diet plus with an equivalent amount of cellulose (placebo).The members of the psyllium group received orange-flavoured sugar-free psyllium Laxofibra [Almeida Prado, Brazil while the control group received microcrystalline cellulose (Avicel PH-101;FMC Corp, Philadelphia)(placebo) instead of psyllium.

Primary Outcome(s)

To comprove an effectiveness of psyllium for the reduction of LDL-cholesterol levels in dyslipidemic children and adolescents investigated in the study.

The effectiveness of psyllium was measured through the difference of the concentration of the LDL-C before and after the period of 8 weeks of intervention in each group and enters the two types of treatments (cellulose and psyllium).

The effectiveness was considered when the presented results had shown to a percentage of reduction of the séricos levels of LDL-C above 5% (primary outcome). The evaluation biochemist was the method used to measure of the lipídico profile before and after the treatment.

Secondary Outcome(s)

Dietary profile and weight maintenance before and after the treatment by participants.

All the participants had its anthropometric (weight, waist circumference, skinfolds thickness) and dietary profiles (record and food frequency questionnaire) measured before and after the treatment.

To comprove a not significant presence to possible adverse effects with respect to the psyllium.
This was based on an open-ended question referring to any unusual symptoms or discomfort, or side-effects such as increased defecation, bloating, flatulence or fullness over the preceding period.

Secondary ID(s)

1772-CEP/HUPE

Source(s) of Monetary Support

Laboratório Farmacêutico Almeida Prado - Brazil

Secondary Sponsor(s)

Hospital universitário Pedro Ernesto/UERJ - Brazil