Fibre supplementation to decrease hunger, improve chronic disease risk factors and weight loss in overweight and obese children.

Not Applicable

Recruiting

• Conditions: Metabolic risk factors; Cardiovascular risk factors; Overweight/obesity; Diet and Nutrition - Obesity; Metabolic and Endocrine - Metabolic disorders; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12617000960358
• Lead Sponsor: Curtin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-04
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Overweight and obese children with a body mass index (BMI) above the 85th percentile of growth charts (WHO BMI for age percentile, approx. BMI 25-35) for age and sex, who are aged between 9-13 years.

Exclusion Criteria

Exclusion criteria will include medications and conditions that influence appetite or metabolism, use of steroids and other agents or medications that may influence lipid metabolism, use of warfarin, diabetes, hypo- and hyperthyroidism, cardiovascular events within in the last 6 months, psychological unsuitability, major systemic diseases, gastrointestinal problems (including difficulty swallowing), dairy allergies (eg. lactose intolerance), proteinuria, liver or renal failure, vegetarianism, passive smoking, substance abuse, and use of fibre supplements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BMI-for-age z-scores (WHO) will be calculated from body weight and height.<br><br>[Baseline, week 8 and week 16 (primary endpoint)];Lipid concentrations from fasting blood tests using point of care device (Samsung LabGeo PT10)<br>[Baseline and week 16];HbA1c concentrations from fasting blood tests using point of care device (A1CNow+)[Baseline and week 16]