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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014