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Effect of Weight Loss on Cholesterol Metabolism in Hereditary Hypercholesterolemias and Overweight or Obesity.

NCT01995149 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2013-11-26

No results posted yet for this study

Summary

Background: Lipid lowering response to weight loss in subjects with genetic hyperlipidemias and overweight or obesity and its effect on cholesterol metabolism has not been studied.

Objective: To explore the effects of weight loss on lipid values and cholesterol metabolism, by measuring circulating non-cholesterol sterols, in overweight or obese subjects with genetic hypercholesterolemias.

Design: The investigators conducted a 6-months weight loss intervention in subjects with the diagnosis of familial hypercholesterolemia (FH) or familial combined hyperlipidemia (FCHL), body mass index \>25 kg/m2, steady weight (±3 kg in the last 3 months) and absence of lipid lowering drugs in the previous 5 weeks. They were advised to follow a hypocaloric diet with a deficit of 600 kcal (30% fat, 15% protein, and 55% carbohydrates) per day as calculated from the person's resting energy expenditure and activity level. Anthropometric data, biochemical analysis including lipids, apolipoproteins and non-cholesterol sterols were evaluated at baseline, 3 months and 6 months.

Conditions

  • Familial Hypercholesterolemias
  • Weight Loss
  • Familial Combined Hypercholesterolemia
  • Obesity

Interventions

BEHAVIORAL

Weight loss and dietary intervention

The weight loss intervention had a total duration of 6 months. Each participant's caloric prescription represented a deficit of 600 kcal per day as calculated from the person's resting energy expenditure and activity level using the Harris-Benedict equation. In general, prescribed energy intake was between 1200 kcal and 1600 kcal/day. Dietary composition consisted on 50-55% of carbohydrates, 15-20% of protein and 30% of fat and included a wide variety of foods typical of a Mediterranean diet. Patients were also provided with recipes and shopping counselling to improve intervention compliance and to achieve the weight loss goal. Individual consultations with a nutritionist were performed twice a month to motivate the weight loss and reinforce the intervention.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Instituto Aragones de Ciencias de la Salud

    lead OTHER_GOV

Principal Investigators

  • Fernando Civeira, MD, PhD · Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01995149 on ClinicalTrials.gov