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Completed

NCT Number: NCT01378767

Health Benefits of a 21-day Daniel Fast

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.

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Key information

Conditions

Effects of Krill Oil on Human Health Behavior Fasting Feeding Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiorespiratory/Metabolic Laboratory

Memphis, Tennessee, 38152, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Krill oil supplementation

Dietary Supplement

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).

Other names: Now Foods Neptune Krill Oil, 1000 mg- 60 Soft Gels, Brand NOW, Part Numbers 14431, 1627, 82048, NOW-01627, NWF-16270, NWF622, UPC 733739016270, Now Foods Coconut Oil, 1000 mg- 120 Soft Gels, Part Numbers 091363-2, 1718, 18918, 24230, 5933510, 6485, 71668, 806542, NWF-17185, NWF119, UPC 733739017185

Primary outcomes

  1. Blood Lipids

    Time frame: Change from baseline at 3 weeks

    Total Cholesterol, LDL-C, HDL-C, VLDL-C, Triglyerides

  2. Glucoregulatory markers

    Time frame: Change from baseline at 3 weeks

    Blood glucose, blood insulin, Serum resistin, serum adiponectin

  3. Markers of Oxidative Stress and Antioxidant Status

    Time frame: Change from baseline at 3 weeks

    Plasma malondialdehyde, plasma hydrogen peroxide, plasma nitrate/nitrite, Trolox Equivalent Antioxidant Capacity (measured in serum)

  4. Blood Pressure

    Time frame: Change from baseline at 3 weeks

    Systolic blood pressure, diastolic blood pressure

  5. C-reactive protein

    Time frame: Change from baseline at 3 weeks

Secondary outcomes

  1. Anthropometric Variables

    Time frame: Change from baseline at 3 weeks

    bodyweight, body mass index, waist circumference, hip circumference, body fat percentage, fat mass, fat free mass

  2. Metabolic Panel

    Time frame: Change from baseline at 3 weeks

    Blood urea nitrogen, creatinine, sodium, potassium, carbon dioxide, calcium, protein, albumin, globulin, bilirubin, alkaline phosphatase, aspartate transaminase, alanine transaminase

  3. Complete Blood Count

    Time frame: Change from baseline at 3 weeks

    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

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2011
Registry last updated
Jun 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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