Metformin vs Conjugated Linoleic Acid and an Intervention Program With Healthy Habits in Obese Children

Laboratorios Silanes

Status and phase: Unknown; Phase 2

Conditions: Obesity

Treatments: Dietary Supplement: Conjugated Linoleic Acid; Drug: Placebo; Drug: metformin; Behavioral: Healthy habits program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02063802

DI/11/311/04/108

Details and patient eligibility

About

The purpose of this clinical trial is to examine the effects of conjugated linoleic acid (CLA) vs metformin along with an intervention program with healthy habits on body composition, weight, M value in CLAMP and clinical laboratory values, as well as molecular and genetic changes in obese children.

Patients from the pediatric service of the Hospital from 8 to 18 years old with a body mass index ≥ Pc 95 and 35kg/m2 are randomized to either interventional group for 4 months.

Enrollment: 120 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients of both sexes between 8 and 18 years old
• Pc BMI ≥ 95 and <35kg/m2,
• No endocrine diseases, including diabetes mellitus
• No systemic diseases
• No genetic diseases
• No pharmacological treatment affecting lipid metabolism or glucose
• No history of acute or prolonged immobilization
• Normal aminotransferases
• Signed Informed consent and assent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

metformin and healthy habits program

Active Comparator group

Description:

1 gr per day. (250mg tablets). The patient takes 2 tablets with breakfast and 2 tablets with dinner and 2 placebo tablets with food by mouth for four months.

Treatment:

Drug: metformin

Behavioral: Healthy habits program

Conjugated Linoleic Acid and healthy habits

Experimental group

Description:

Total dose: 3gr per day (500mg capsules). The patient takes 2 capsules with breakfast, 2 capsules with lunch and 2 capsules with dinner by mouth for four months.

Treatment:

Dietary Supplement: Conjugated Linoleic Acid

Behavioral: Healthy habits program

Placebo and healthy habits program

Placebo Comparator group

Description:

Total dose 6 tablets per day. The patient takes 2 tablets with breakfast, two tablets with lunch and two tablets with dinner by mouth for four months.

Treatment:

Drug: Placebo

Behavioral: Healthy habits program