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Completed

NCT Number: NCT01503047

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario La Paz

Madrid, 28046, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tonalin®

Dietary Supplement

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

Dietary Supplement

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 outcomes

  1. body composition(DXA)

    Time frame: 0, 3, 6 months

Secondary outcomes

  1. anthropometric parameters

    Time frame: 0,1, 2, 3, 4, 5 and 6 month

    paramteres measured were: Weight, Height and Waist Circunference.

  2. Biochemical parameters

    Time frame: 0, 3 and 6 month

    lipid profile glucose, insulin CR-P PAI-1 adiponectin, leptin creatinine GPT and GOT transaminases

  3. HOMA-Index

    Time frame: 0, 3, 6 month

    insulin sensitivity index was calculated using the formula: HOMA-IR = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22•5.

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Other

Registry information

Official study title

Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tonalin(R)Intake in Overweight People

Acronym: CLA

Important dates

Study start
2008
Primary completion
2010
First posted
Jan 2, 2012
Registry last updated
Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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