Health Benefits of a 21-day Daniel Fast

June 20, 2011 updated by: University of Memphis

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

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Memphis, Tennessee, United States, 38152
        • Cardiorespiratory/Metabolic Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Krill oil capsules
Two grams per day daily for 21 days
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
Placebo Comparator: Coconut oil capsules
Two grams per day for 21 days
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Lipids
Time Frame: Change from baseline at 3 weeks
Total Cholesterol, LDL-C, HDL-C, VLDL-C, Triglyerides
Change from baseline at 3 weeks
Glucoregulatory markers
Time Frame: Change from baseline at 3 weeks
Blood glucose, blood insulin, Serum resistin, serum adiponectin
Change from baseline at 3 weeks
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)
Change from baseline at 3 weeks
Blood Pressure
Time Frame: Change from baseline at 3 weeks
Systolic blood pressure, diastolic blood pressure
Change from baseline at 3 weeks
C-reactive protein
Time Frame: Change from baseline at 3 weeks
Change from baseline at 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline at 3 weeks
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
Change from baseline at 3 weeks
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
Change from baseline at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Richard J Bloomer, Doctorate, University of Memphis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 10, 2011

First Submitted That Met QC Criteria

June 20, 2011

First Posted (Estimate)

June 22, 2011

Study Record Updates

Last Update Posted (Estimate)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 20, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 110184

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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