N/A
N=57
Oxidized Omega-3 Supplements With Different Oxidation
Overweight
Bottom Line
View on ClinicalTrials.gov: NCT01799720 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30) — 70.17; 68.77; 75.15; 69.38 kilogram
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Less oxidized oil and diet (Dietary_supplement); More oxidized oil and diet (Dietary_supplement); Hypercholesterolemic diet (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Universidad Miguel Hernandez de Elche
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30) |
70.17; 68.77; 75.15; 69.38; 67.78; 74.29 | — |
| SECONDARY Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). |
1.60; 1.59; 1.61; 1.60; 1.59; 1.61 | — |
| SECONDARY Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). |
27.43; 28.65; 29.00; 27.10; 26.94; 28.64 | — |
| SECONDARY Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30) |
86.5; 87.2; 86.0; 86.5; 87.2; 86.0 | — |
| SECONDARY Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). |
129.9; 123.7; 118.6; 118.2; 120.2; 119.4 | — |
| SECONDARY Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). |
77.2; 73.9; 73.3; 68.9; 75.1; 72.8 | — |
| SECONDARY Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). |
103.35; 108.96; 99.72; 116.24; 111.37; 108.26 | — |
| SECONDARY Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). |
246.64; 232.94; 236.78; 217.76; 237.52; 227.22 | — |
| SECONDARY Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). |
164.41; 160.41; 174.83; 125.52; 116.88; 130.04 | — |
| SECONDARY Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). |
22.70; 24.90; 23.54; 20.69; 18.46; 19.94 | — |
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.
Eligibility Criteria
Inclusion Criteria
- presence of dyslipemia with no indication of drug treatment
- blood cholesterol levels ranging 250-300 mg/dL
- triglycerides (TG) 160-175 mg/dL
Exclusion Criteria
- pregnancy
- lactation
- participation in another supplementary feeding programme
Data sourced from ClinicalTrials.gov (NCT01799720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.