- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01378767
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
Status
Completed
Conditions
Intervention / Treatment
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
-
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Tennessee
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Memphis, Tennessee, United States, 38152
- Cardiorespiratory/Metabolic Laboratory
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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:
|
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:
|
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.
Sponsor
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
Keywords
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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