None listed
Conditions
Brief summary
Introduction: Diet is a key component in the disease susceptibility of individuals. Vitamin D, omega 3 polyunsaturated fatty acids, Co-enzyme Q10 and carotenoids are associated with immune regulatory functions. Vitamin D supplementation, omega 3 fatty acids and antioxidants have been shown to be beneficial in reducing inflammation especially in people with inflammatory disorders e.g. inflammatory bowel disease. Study Design: Double blinded, randomised, with cross-over. The study population (n=30) was recruited from Auckland, New Zealand. The intervention , the nutrient supplement, Lester's Oil - Registered trade mark) or the control (the medium chain triglyceride-[MCT- 8+10 Triglycerides] was for four weeks, followed by a washout of four weeks followed by the control or intervention for four weeks. Methods Blood, urine and faecal samples were collected before and after each 4 week intervention from the participants and inflammatory markers (C-reactive protein and faecal calprotectin), vitamin D:25-OH, plasma lipid metabolic profiling (FAMES), lipid profiles, Co-enzyme Q10, carotenoids, lipid peroxidation, and full blood count measures were taken. A food variety score (FVS), Quality of Life (QoL) and stool questionnaires were also conducted. The QoL score was measured using a numeric scale from 1 – 10. The FVS was a list of foods and participants indicated which ones were eaten over each seven day time period. The stool chart measured daily frequency, ease, volume and consistency of each stool on a number scale. The outcomes of interest were measured at baseline, and the end of each phase or at the end of the trial.
Interventions
This is a double blinded, randomised, placebo controlled, cross-over trial
This trial will involve 30 healthy participants who will be randomised to two treatment groups, each group consisting of 15 participants. In the first group, the 15 participants will take the nutrient supplement (Lester's Oil) or placebo for 4 weeks. Each nutrient capsule is made up mainly of six ingredients: vitamin D:25-OH (500IU), long chain PUFA-Omega-3 from fish oil [more than 500mg] as well as CoQ10 (50mg), zeaxan
This is a double blinded, randomised, placebo controlled, cross-over trial This trial will involve 30 healthy participants who will be randomised to two treatment groups, each group consisting of 15 participants. In the first group, the 15 participants will take the nutrient supplement (Lester's Oil) or placebo for 4 weeks. Each nutrient capsule is made up mainly of six ingredients: vitamin D:25-OH (500IU), long chain PUFA-Omega-3 from fish oil [more than 500mg] as well as CoQ10 (50mg), zeaxanthin (0.82mg), lutein (3mg) and astaxanthin (500mcg). Each nutrient capsule also contains natural mixed tocopherols, vitamin E with ascorbyl palmitate (1mg) and is enclosed in a soft gel composed of gelatin, glycerine soft gel, beeswax and natural annatto. This will follow with a 4 week period of no supplementation and then another four week period of taking a similarly encapsulated ‘medium-chain tryglyceride oil’ placebo. The placebo was a Medium Chain triglyceride oil – [MCT- 8+10 Triglyceride] (MCT). Its major components were FAD - C6:0 Caproic 0.0 2.0%; FAD - C8:0 Caprylic 50.0 -80.0 %; FAD - C10:0 Capric 20.0 -50.0 %; FAD - C12:0 Lauric 0.03.0 %. Two capsules of the nutrient supplement or placebo were taken daily, (orally), with the participants lunch or dinner meal The second group will take the encapsulated ‘medium-chained oil’ placebo for the first four weeks, followed by a four week period of no supplementation. The nutrient supplement will then be taken for the remaining four weeks, All participants are blinded to the treatment regime they are on. The levels of CoQ10 were determined in serum for each trial participant at each collection point as a measure of dietary uptake and compliance in the study. Participants were also asked to return their containers of left over capsules (more capsules than needed by the study were given) and these were counted as another indicator of compliance.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Free from any major illnesses or chronic conditions Not currently taking any Vitamin D, fish oil/flax seed oil supplements, or eating more than 4 servings of oily fish (salmon, mackerel) each week. Be able to fast overnight and be able to attending the study clinic
Exclusion criteria
A history of cancer in last 5 years excluding non- melanoma skin cancers A history of gastrointestinal disorders (Ulcerative colitis, Crohns Disease or Irritable Bowel Syndrome) Prescribed medication changes in last 3 months prior to the trial Have taken antibiotics in the month prior to the study commences On blood thinning medication (e.g. Aspirin) Pregnancy Smoking more than 10 pack years
Outcome results
None listed