Conjugated Linoleic Acid (1:1 Isomer Mixture) Intake in Overweight People (CLA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ignacio Galicia, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
ClinicalTrials.gov Identifier:
NCT01503047
First received: December 30, 2011
Last updated: January 2, 2012
Last verified: January 2012
  Purpose

The aim of the study was to examine the effects and safety of 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) on weight control and body composition in healthy overweight individuals who maintained their normal dietary and exercise patterns.


Condition Intervention Phase
Overweight
Obesity
Dietary Supplement: Tonalin®
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tonalin(R)Intake in Overweight People

Further study details as provided by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz:

Primary Outcome Measures:
  • body composition(DXA) [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • anthropometric parameters [ Time Frame: 0,1, 2, 3, 4, 5 and 6 month ] [ Designated as safety issue: No ]
    paramteres measured were: Weight, Height and Waist Circunference.

  • Biochemical parameters [ Time Frame: 0, 3 and 6 month ] [ Designated as safety issue: Yes ]
    lipid profile glucose, insulin CR-P PAI-1 adiponectin, leptin creatinine GPT and GOT transaminases

  • HOMA-Index [ Time Frame: 0, 3, 6 month ] [ Designated as safety issue: Yes ]
    insulin sensitivity index was calculated using the formula: HOMA-IR = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22•5.


Enrollment: 50
Study Start Date: March 2008
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CLA group
Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) (CLA group)
Dietary Supplement: Tonalin®
Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) (CLA group)
Placebo Comparator: Placebo group
Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g oleic acid (placebo, P group.
Dietary Supplement: Placebo
Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g oleic acid (placebo)

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged 30-55 years
  • grade II overweight (BMI≥27 but <30 kg/m2)
  • not to be adhered to any calorie restriction diet
  • not to be taking any weight control medication or have lost more than 5 kg in the three months prior to the study

Exclusion Criteria:

  • suffering of serious concomitant disease such as diabetes mellitus type II, metabolic syndrome (according to the criteria of the Adult Treatment Panel III), cancer, kidney disease, HIV, tuberculosis, cardiovascular disease, chronic obstructive pulmonary disease, eating disorders.
  • having undergone bariatric surgery and/or intestinal resection
  • breastfeeding and pregnancy.
  • not to give their signed, informed consent to be included in the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01503047

Locations
Spain
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
  More Information

Additional Information:
No publications provided by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ignacio Galicia, Director, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
ClinicalTrials.gov Identifier: NCT01503047     History of Changes
Other Study ID Numbers: HULP-2297
Study First Received: December 30, 2011
Last Updated: January 2, 2012
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014