Evaluation of the effect of supplementation with omega-3 fatty acids and vitamin D on blood sugar, lipids, cholesterol and inflammation markers, and body weight, in patients with diabetes mellitus

Effect of omega-3 fatty acid supplementation and vitamin D on the immuno-inflammatory process in patients with type 2 diabetes mellitus in Mexico

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN97792326

Enrollment

120

Registered

2016-10-24

Start date

2015-03-01

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus Nutritional, Metabolic, Endocrine Type 2 Diabetes Mellitus

Interventions

Participating health clinics are randomised to one of four groups. Group 1: Participants receive three gelcaps (Vitamin D-3 General Nutrition Centers™) daily, to be consumed one per meal time, with a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosed type 2 diabetes mellitus 2. Age between 25 and 55 years 3. BMI = 29.9 4. With no other chronic pathology 5. No insulin treatment 6. HOMA = 2.4

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation 2. Non-mixed Mexican origin (native or immigrants) 3. Lack of data from measurements

Design outcomes

Primary

Measure	Time frame
1. Glucose (Cat. GL1611), glycosylated haemoglobin (Cat.HA3830A), total cholesterol (Cat. CHO215), HDL-cholesterol (Cat. CH3811A), LDL (Cat. CH3811B) & triacylglycerides (Cat. Tr213) are assessed using an ultrasensitive colorimetric method in an automated Selectra II equipment, with commercial RANDOX™ reactants. VLDL was calculated with the Friedwald equation (Friedwald et.al. 1972). All measurements were done at baseline and 24 weeks 2. Plasma fatty acids are measured using chromatography and methylation at baseline and 24 weeks 3. Vitamin D and insulin are measured using a commercial ELISA kit from R&D Systems (Cat. 51081) assay at baseline and 24 weeks 4. Cytokines are assessed using Milliplex Human Citokine Five Plex (Cat. MPXHCYTO-60K-05) for TNFa, IFN-?, IL-1ß, IL4 and IL10 and the Milliplex Human Citokine One Plex (Cat. MPXHCYTO-B-01) for TGF- ß, at baseline and 24 weeks 5. Adipokines Adiponectin, Resistin and Leptin levels are assessed with the Milliplex Human Adipokine Magnetic Bead Panel (Cat.HADK1-61K-02 and Cat.HADK1-61K-01) at baseline and 24 weeks	—

Measure

Time frame

1. Glucose (Cat. GL1611), glycosylated haemoglobin (Cat.HA3830A), total cholesterol (Cat. CHO215), HDL-cholesterol (Cat. CH3811A), LDL (Cat. CH3811B) & triacylglycerides (Cat. Tr213) are assessed using an ultrasensitive colorimetric method in an automated Selectra II equipment, with commercial RANDOX™ reactants. VLDL was calculated with the Friedwald equation (Friedwald et.al. 1972). All measurements were done at baseline and 24 weeks 2. Plasma fatty acids are measured using chromatography and methylation at baseline and 24 weeks 3. Vitamin D and insulin are measured using a commercial ELISA kit from R&D Systems (Cat. 51081) assay at baseline and 24 weeks 4. Cytokines are assessed using Milliplex Human Citokine Five Plex (Cat. MPXHCYTO-60K-05) for TNFa, IFN-?, IL-1ß, IL4 and IL10 and the Milliplex Human Citokine One Plex (Cat. MPXHCYTO-B-01) for TGF- ß, at baseline and 24 weeks 5. Adipokines Adiponectin, Resistin and Leptin levels are assessed with the Milliplex Human Adipokine Magnetic Bead Panel (Cat.HADK1-61K-02 and Cat.HADK1-61K-01) at baseline and 24 weeks

—

Secondary

Measure	Time frame
1. Dietary intake is assessed through 24-hour dietary recall at baseline and every four weeks until the final evaluation at 24 weeks 2. Anthropometry (weight, height, BMI) is assessed with a portable stadiometer and weighing scale at baseline and 24 weeks 3. Treatment adherence is assessed with the Morinksey-Green and Haynes-Sackett tests every four weeks from baseline to week 24	—

Countries

Mexico

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026