Health Benefits of a 21-day Daniel Fast

Study Overview
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Brief Summary
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The investigators hypothesized that individuals supplementing with krill oil capsules (two grams per day) would experience enhanced improvements in health-related variables during a 21-day Daniel Fast.

Detailed Description
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One of the main purposes of the this investigation was to determine if krill oil supplementation (two grams per day for 21 days) enhances the effects of a 21-day Daniel Fast, particularly in regards to blood lipids and lipid peroxidation. The investigators were also interested in determining if adiponectin and/or resistin change in response to the fast, as these adipokines could potentially mediate the favorable glucoregulatory changes the investigators observed in our initial investigation of a 21-day Daniel Fast. Finally, the investigators sought to determine the changes in macronutrient and micronutrient intake during a Daniel Fast, and how these dietary changes affect our selected hemodynamic, anthropometric, blood lipid, glucoregulatory, oxidative stress, inflammatory, renal, and hepatic biomarkers.

Official Title
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Biochemical, Hemodynamic, and Anthropometric Effects of a 21-day Daniel Fast in Men and Women

Conditions
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Effects of Krill Oil on Human Health

Intervention / Treatment
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* Dietary Supplement: Krill oil supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be 18 years of age or older. Must be willing to partake in a vegan diet for 21 days. Must be willing to consume either krill oil or coconut oil capsules (assigned randomly). Exclusion Criteria: Smokers regular consumption of antioxidant supplements women who were pregnant or seeking to become pregnant poor veins (veins that made it difficult to successfully obtain a blood draw - this was determined via a visual inspection)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Krill oil capsules<br>Two grams per day daily for 21 days | Dietary Supplement: Krill oil supplementation<br>* During a 21-day Daniel Fast, group one supplemented with krill oil capsules (two grams per day) while group two supplemented with a placebo (coconut oil capsules at two grams per day).<br>* Other names: UPC 733739017185;|
| Placebo Comparator: Coconut oil capsules<br>Two grams per day for 21 days | Dietary Supplement: Krill oil supplementation<br>* During a 21-day Daniel Fast, group one supplemented with krill oil capsules (two grams per day) while group two supplemented with a placebo (coconut oil capsules at two grams per day).<br>* Other names: UPC 733739017185;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Lipids | Total Cholesterol, LDL-C, HDL-C, VLDL-C, Triglyerides | Change from baseline at 3 weeks | 
| Glucoregulatory markers | Blood glucose, blood insulin, Serum resistin, serum adiponectin | Change from baseline at 3 weeks | 
| Markers of Oxidative Stress and Antioxidant Status | Plasma malondialdehyde, plasma hydrogen peroxide, plasma nitrate/nitrite, Trolox Equivalent Antioxidant Capacity (measured in serum) | Change from baseline at 3 weeks | 
| Blood Pressure | Systolic blood pressure, diastolic blood pressure | Change from baseline at 3 weeks | 
| C-reactive protein |  | Change from baseline at 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric Variables | bodyweight, body mass index, waist circumference, hip circumference, body fat percentage, fat mass, fat free mass | Change from baseline at 3 weeks | 
| Metabolic Panel | Blood urea nitrogen, creatinine, sodium, potassium, carbon dioxide, calcium, protein, albumin, globulin, bilirubin, alkaline phosphatase, aspartate transaminase, alanine transaminase | Change from baseline at 3 weeks | 
| Complete Blood Count | White blood cells, red blood cells, hemoglobin, hematocrit, mean cell volume, mean cell hemoglobin, mean corpuscular hemoglobin concentration, red blood cell distribution width, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils | Change from baseline at 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary restriction, oxidative stress, fasting