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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Tonalin®
Placebo
Sponsored by
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CLA group

Placebo group

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

body composition(DXA)

Secondary Outcome Measures

anthropometric parameters
paramteres measured were: Weight, Height and Waist Circunference.
Biochemical parameters
lipid profile glucose, insulin CR-P PAI-1 adiponectin, leptin creatinine GPT and GOT transaminases
HOMA-Index
insulin sensitivity index was calculated using the formula: HOMA-IR = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22•5.

Full Information

First Posted
December 30, 2011
Last Updated
January 2, 2012
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
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1. Study Identification

Unique Protocol Identification Number
NCT01503047
Brief Title
Conjugated Linoleic Acid (1:1 Isomer Mixture) Intake in Overweight People
Acronym
CLA
Official Title
Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tonalin(R)Intake in Overweight People
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CLA group
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Tonalin®
Intervention Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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)
Primary Outcome Measure Information:
Title
body composition(DXA)
Time Frame
0, 3, 6 months
Secondary Outcome Measure Information:
Title
anthropometric parameters
Description
paramteres measured were: Weight, Height and Waist Circunference.
Time Frame
0,1, 2, 3, 4, 5 and 6 month
Title
Biochemical parameters
Description
lipid profile glucose, insulin CR-P PAI-1 adiponectin, leptin creatinine GPT and GOT transaminases
Time Frame
0, 3 and 6 month
Title
HOMA-Index
Description
insulin sensitivity index was calculated using the formula: HOMA-IR = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22•5.
Time Frame
0, 3, 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24506387
Citation
Lopez-Plaza B, Bermejo LM, Koester Weber T, Parra P, Serra F, Hernandez M, Palma Milla S, Gomez-Candela C. Effects of milk supplementation with conjugated linoleic acid on weight control and body composition in healthy overweight people. Nutr Hosp. 2013 Nov 1;28(6):2090-8.
Results Reference
derived
Links:
URL
http://www.idipaz.es
Description
institution web

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

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