Health Benefits of a 21-day Daniel Fast

This study has been completed.
Sponsor:
Information provided by:
University of Memphis
ClinicalTrials.gov Identifier:
NCT01378767
First received: June 10, 2011
Last updated: June 20, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Effects of Krill Oil on Human Health
Dietary Supplement: Krill oil supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Biochemical, Hemodynamic, and Anthropometric Effects of a 21-day Daniel Fast in Men and Women

Further study details as provided by University of Memphis:

Primary Outcome Measures:
  • Blood Lipids [ Time Frame: Change from baseline at 3 weeks ] [ Designated as safety issue: No ]
    Total Cholesterol, LDL-C, HDL-C, VLDL-C, Triglyerides

  • Glucoregulatory markers [ Time Frame: Change from baseline at 3 weeks ] [ Designated as safety issue: No ]
    Blood glucose, blood insulin, Serum resistin, serum adiponectin

  • Markers of Oxidative Stress and Antioxidant Status [ Time Frame: Change from baseline at 3 weeks ] [ Designated as safety issue: No ]
    Plasma malondialdehyde, plasma hydrogen peroxide, plasma nitrate/nitrite, Trolox Equivalent Antioxidant Capacity (measured in serum)

  • Blood Pressure [ Time Frame: Change from baseline at 3 weeks ] [ Designated as safety issue: No ]
    Systolic blood pressure, diastolic blood pressure

  • C-reactive protein [ Time Frame: Change from baseline at 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anthropometric Variables [ Time Frame: Change from baseline at 3 weeks ] [ Designated as safety issue: No ]
    bodyweight, body mass index, waist circumference, hip circumference, body fat percentage, fat mass, fat free mass

  • Metabolic Panel [ Time Frame: Change from baseline at 3 weeks ] [ Designated as safety issue: No ]
    Blood urea nitrogen, creatinine, sodium, potassium, carbon dioxide, calcium, protein, albumin, globulin, bilirubin, alkaline phosphatase, aspartate transaminase, alanine transaminase

  • Complete Blood Count [ Time Frame: Change from baseline at 3 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 39
Study Start Date: September 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Krill oil capsules
Two grams per day daily for 21 days
Dietary Supplement: Krill oil supplementation
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
Dietary Supplement: Krill oil supplementation
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01378767

Locations
United States, Tennessee
Cardiorespiratory/Metabolic Laboratory
Memphis, Tennessee, United States, 38152
Sponsors and Collaborators
University of Memphis
Investigators
Principal Investigator: Richard J Bloomer, Doctorate University of Memphis
  More Information

No publications provided

Responsible Party: Dr. Richard Bloomer, University of Memphis
ClinicalTrials.gov Identifier: NCT01378767     History of Changes
Other Study ID Numbers: 110184
Study First Received: June 10, 2011
Last Updated: June 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Memphis:
Dietary restriction
oxidative stress
fasting

ClinicalTrials.gov processed this record on April 17, 2014