8 weeks of 25 g/day of milled chia supplemented-isocaloric diet

Non-Alcoholic Fatty Liver Disease

Dietary Modification

8 weeks of an isocaloric diet supplemented with 25 g/day of milled chia

Milled chia seeds

Chia Supplementation and Non Alcoholic Fatty Liver Disease

Effect of a Chia Supplemented Diet (Salvia Hispanica) on the Cardiometabolic Risk Profile in Patients With NAFLD (Non Alcoholic Fatty Liver Disease)

To assess the effect of 25 g/day of milled chia in 25 patients with NAFLD.Improvement of LSAI (liver spleen attenuation index) measured by computed tomography In a single-arm experimental design study

Increase in Alpha linolenic acid with chia supplemented diet. Measured by gas chromatography.

Improvement of lipid parameters (total colesterol, LDL-C, triglycerides, HDL-C) including free fatty acids

Aida Medina Urrutia

Medical sience investigator

Instituto Nacional de Cardiologia Ignacio Chavez

The participant will arrive fasted at he research center. After installing a cathether and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive the omega-3 fatty acidsesterified in a reconstitute triglyceride form as a unique dose of 1.5 g EPA + DHA in TG form + 45 mg vitamin K2.The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of omega-3 fatty acids in the plasma and a side effect questionnaire will be administered to monitor side effects.

The participant will arrive fasted at he research center. After installing a cathether and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive the omega-3 fatty acids in ethyl esters form as a unique dose of 1.5 g EPA + DHA in TG form + 45 mg vitamin K2.The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of omega-3 fatty acids in the plasma and a side effect questionnaire will be administered to monitor side effects.

The participant will arrive fasted at he research center. After installing a cathether and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive the omega-3 fatty acids in MaxSimil® form as a unique dose of 1.5 g EPA + DHA in TG form + 45 mg vitamin K2.The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of omega-3 fatty acids in the plasma and a side effect questionnaire will be administered to monitor side effects.

Healthy

The intervention is a randomized double bond cross over design testing the pharmacokinetics of a monoglyceride formulation compared to a triglyceride and an ethyl ester form.
Treatments are randomly assigned on days 0, 7 and 14 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 9, 10, 12 and 24 hours. Each participant will perform all three treatments, with a minimum of 6 days between treatments. A questionnaire will document the side effects felt by participants during the omega-3 supplement taking day.

Omega-3 + vitamin K2 (TG form of omega-3)

Omega-3 + vitamin K2 (EE form of omega-3)

The intervention is a randomized double blind cross over design testing the pharmacokinetics of a monoglyceride formulation compared to a triglyceride and an ethyl ester form.
Treatments are randomly assigned on days 0, 7 and 14 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 9, 10, 12 and 24 hours. Each participant will perform all three treatments, with a minimum of 6 days between treatments. At each blood draw time points, a questionnaire will be administered to the particpant to monitor if they experiencec side effects with the dietary supplement they ingested in the morning.

Omega-3 + vitamin K2 [MaxSimil (MAG form of omega-3)]

Melanie Plourde

MaxSimil and Vitamin K2: Determining Their Bioavailability

Pharmacokinetics of a Combination of Omega-3 Fatty Acids and Vitamin K2 as a Natural Product

Plasma omega-3 (DHA and EPA) levels will be measured by gas phase chromatography while plasma vitamin K2 level will be measured by high-performance liquid chromatography (HPLC), each being performed randomly blindly. After GC and HPLC analyzes, area under the curve (AUC) 0-24 hours will be calculated, as the first parameter of the PK. Statistical analyzes will then be performed on this PK parameter.

Plasma Omega-3 (DHA and EPA) will be measured by gas phase chromatography while plasma vitamin K2 will be measured by high-performance liquid chromatography (HPLC), each being performed randomly blindly. After GC and HPLC analyzes, AUC 0-6 hours (absorption study) will be calculated, as the second parameter of the PK. Statistical analyzes will then be performed on this PK parameter.

Plasma Omega-3 (DHA and EPA) will be measured by gas phase chromatography while plasma vitamin K2 will be measured by high-performance liquid chromatography (HPLC), each being performed randomly blindly. After GC and HPLC analyzes, maximum concentration will be calculated, as the third parameter of the PK. Statistical analyzes will then be performed on this PK parameter.

Plasma Omega-3 (DHA and EPA) will be measured by gas phase chromatography while plasma vitamin K2 will be measured by high-performance liquid chromatography (HPLC), each being performed randomly blindly. After GC and HPLC analyzes, time when the maximum concentration is reached will be calculated, as the fourth parameter of the PK. Statistical analyzes will then be performed on this PK parameter.

The side effects of EPA + DHA type omega-3 supplements, all mild, belong to the category of gastrointestinal discomfort. These include dysgeusia (fishy taste or taste alteration), belching and nausea. A questionnaire will document the side effects felt by participants during the omega-3 supplement taking day. Statistical analyzes will then be performed on the evaluation of side effects (including gastrointestinal discomfort) by questionnaire.

We do not plan to share individual participant data to other researchers

Mélanie Plourde

Associate professor, Department of medicine, Geriatric service

Université de Sherbrooke

Samuel Fortin, SFC pharma and associate professor UQAR

Double-blind controlled-randomized pharmacokinetic (PK) pilot study with crossover design (10 men and 10 women), with a minimum of 6 days between treatments

Neither the participant nor the research nurse will know the administration order of the different treatments administered. All plasma samples collected during the research project will be anonymized i.e. it will not be possible to identify the participant by his name since a number will be assigned to him. The code key linking the participant's name to his number will be stored, with access restricted to those designated by the principal investigator. The data file is also protected by a password.

linolenic acid/nausée

Chia Supplementation and Non Alcoholic Fatty Liver Disease

MaxSimil and Vitamin K2: Determining Their Bioavailability

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