Oxidized Omega-3 Supplements With Different Oxidation

NCT01799720 | Completed Results DMC

• 3 other identifiers: Elena García-GarcíaEnrique Roche ColladoVicente Micol Molina
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The oxidation level of unsaturated fatty acid supplements commercialized in capsules could be a serious problem for manufacturers and a risk to consumers; health by ingesting substances whose effects are not desired. Therefore, the main objective of this paper is to analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose the investigators have designed a single-blind, parallel-groups, randomized controlled trial. Finally, 52 women between 25 and 75 years old were randomly distributed into three groups: (1) took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, (2) took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet and (3) no capsules, only received the diet. There was a 30 days follow-up . All groups followed a low cholesterol diet. Circulating glucose, total cholesterol, triglycerides and glutamic pyruvic transaminase were determined at the beginning and end of a 30 day period.

Conditions

Overweight

Keywords

blood cholesterol; blood lipid profile; triglycerides; commercial pills; fish oil; lipid peroxidation; Circulating lipidic profile

Outcome Measures

Primary Outcomes (1)

• Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)

  In this table the investigators present the weight (kilogram) of the three intervented groups. Data are mean ± sem.

  Days 1 and 30

Secondary Outcomes (9)

• Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).

  Days 1 and 30

• Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).

  Days 1 and 30

• Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)

  Days 1 and 30

• Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).

  Days 1 and 30

• Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).

  Days 1 and 30

Study Arms (3)

Less oxidized oil and diet

EXPERIMENTAL

Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days

Dietary Supplement: Less oxidized oil and diet

More oxidized oil and diet

EXPERIMENTAL

Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Participants from group 2 took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet . Follow-up 30 days

Dietary Supplement: More oxidized oil and diet

Hypercholesterolemic diet

EXPERIMENTAL

Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Participants from group 3 only took diet and no capsules. Follow-up 30 days

Drug: Hypercholesterolemic diet

Interventions

Less oxidized oil and diet DIETARY_SUPPLEMENT

Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Finally 52 women between 25 and 75 years old randomly were distributed into three groups. Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, . Follow-up 30 days

Also known as: less oxidized oil

Less oxidized oil and diet

More oxidized oil and diet DIETARY_SUPPLEMENT

Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Finally 52 women between 25 and 75 years old randomly were distributed into three groups. Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet . Follow-up 30 days

Also known as: More oxidized oil

More oxidized oil and diet

Hypercholesterolemic diet DRUG

Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Finally 52 women between 25 and 75 years old randomly were distributed into three groups. Participants from group 3 only received the diet and no capsules. Follow-up 30 days

Hypercholesterolemic diet

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of dyslipemia with no indication of drug treatment
• blood cholesterol levels ranging 250-300 mg/dL
• triglycerides (TG) 160-175 mg/dL

You may not qualify if:

• pregnancy
• lactation
• participation in another supplementary feeding programme

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Instituto de Salud Carlos III: collaborator
• University of Alicante: collaborator

Study Sites (1)

Pharmacy Iborra Campos

Elche, Alicante, 03202, Spain

Location

Related Publications (1)

• Garcia-Hernandez VM, Gallar M, Sanchez-Soriano J, Micol V, Roche E, Garcia-Garcia E. Effect of omega-3 dietary supplements with different oxidation levels in the lipidic profile of women: a randomized controlled trial. Int J Food Sci Nutr. 2013 Dec;64(8):993-1000. doi: 10.3109/09637486.2013.812619. Epub 2013 Jul 18.

  PMID: 23863036 DERIVED

MeSH Terms

Conditions

Overweight

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Dr. Elena García García
• Organization: Universidad Miguel Hernández

egarcia@umh.es

965222025

Study Officials

• Elena García, PDI

  Universidad Miguel Hernandez de Elche

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD,PID

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: February 27, 2013
• Study Start: October 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 3, 2015
• Results First Posted: September 15, 2014

Record last verified: 2015-07

Locations

ES (1)