Effects of Krill Oil on Human HealthNCT01378767
Health Benefits of a 21-day Daniel Fast
A study testing Krill oil supplementation in people with Effects of Krill Oil on Human Health, run by University of Memphis at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Effects of Krill Oil on Human Health
- What is being tested?
- Krill oil supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiorespiratory/Metabolic Laboratory
Memphis, Tennessee, 38152
About this study
Official title: 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.
Read the 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.
- Conditions
- Effects of Krill Oil on Human Health
- Being tested
- Krill oil supplementation
- Keywords
- Dietary restriction, oxidative stress, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill oil supplementationDietary supplement
Also called Now Foods Neptune Krill Oil, 1000 mg- 60 Soft Gels, Brand NOW, Part Numbers 14431, 1627, 82048, NOW-01627, NWF-16270, NWF622, UPC 733739016270
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).
| Study group | Role | What they receive |
|---|---|---|
| Krill oil capsules | Active comparator | Two grams per day daily for 21 days Receives: Dietary Supplement: Krill oil supplementation |
| Coconut oil capsules | Placebo comparator | Two grams per day for 21 days Receives: Dietary Supplement: Krill oil supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Lipids
Total Cholesterol, LDL-C, HDL-C, VLDL-C, Triglyerides
Measured: Change from baseline at 3 weeks
Glucoregulatory markers
Blood glucose, blood insulin, Serum resistin, serum adiponectin
Measured: Change from baseline at 3 weeks
Markers of Oxidative Stress and Antioxidant Status
Plasma malondialdehyde, plasma hydrogen peroxide, plasma nitrate/nitrite, Trolox Equivalent Antioxidant Capacity (measured in serum)
Measured: Change from baseline at 3 weeks
Blood Pressure
Systolic blood pressure, diastolic blood pressure
Measured: Change from baseline at 3 weeks
C-reactive protein
Measured: Change from baseline at 3 weeks
Secondary outcomes (3)
Anthropometric Variables
bodyweight, body mass index, waist circumference, hip circumference, body fat percentage, fat mass, fat free mass
Measured: Change from baseline at 3 weeks
Metabolic Panel
Blood urea nitrogen, creatinine, sodium, potassium, carbon dioxide, calcium, protein, albumin, globulin, bilirubin, alkaline phosphatase, aspartate transaminase, alanine transaminase
Measured: Change from baseline at 3 weeks
Complete Blood Count
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
Measured: Change from baseline at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effects of Krill Oil on Human HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Investigators
- Richard J Bloomer, Doctorate, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378767
- Sponsor's protocol ID
- 110184
- Status last verified
- Jun 2011
- First submitted
- 10 Jun 2011
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Trepanowski JF, Kabir MM, Alleman RJ Jr, Bloomer RJ. A 21-day Daniel fast with or without krill oil supplementation improves anthropometric parameters and the cardiometabolic profile in men and women. Nutr Metab (Lond). 2012 Sep 13;9(1):82. doi: 10.1186/1743-7075-9-82.
PubMed 22971786
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical, Hemodynamic, and Anthropometric Effects of a 21-day Daniel Fast in Men and Women
- ClinicalTrials.gov ID
- NCT01378767
- Acronym / sponsor ID
- 110184
- Conditions
- Effects of Krill Oil on Human Health
- Keywords
- Dietary restriction, oxidative stress, fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Krill oil capsules | Active comparator | Dietary Supplement: Krill oil supplementationTwo grams per day daily for 21 days |
| Coconut oil capsules | Placebo comparator | Dietary Supplement: Krill oil supplementationTwo grams per day for 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Krill oil supplementationAlso: Now Foods Neptune Krill Oil, 1000 mg- 60 Soft Gels, Brand NOW, Part Numbers 14431, 1627, 82048, NOW-01627, NWF-16270, NWF622, UPC 733739016270During 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). | Dietary supplement | Coconut oil capsules, Krill oil capsules |
Primary outcome
Blood Lipids
Time frame: Change from baseline at 3 weeks
Total Cholesterol, LDL-C, HDL-C, VLDL-C, Triglyerides
Glucoregulatory markers
Time frame: Change from baseline at 3 weeks
Blood glucose, blood insulin, Serum resistin, serum adiponectin
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)
Blood Pressure
Time frame: Change from baseline at 3 weeks
Systolic blood pressure, diastolic blood pressure
C-reactive protein
Time frame: Change from baseline at 3 weeks
3 secondary outcomes
Anthropometric Variables
Time frame: Change from baseline at 3 weeks
Metabolic Panel
Time frame: Change from baseline at 3 weeks
Complete Blood Count
Time frame: Change from baseline at 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
- Derived from this study: PubMed 22971786Trepanowski JF, Kabir MM, Alleman RJ Jr, Bloomer RJ. A 21-day Daniel fast with or without krill oil supplementation improves anthropometric parameters and the cardiometabolic profile in men and women. Nutr Metab (Lond). 2012 Sep 13;9(1):82. doi: 10.1186/1743-7075-9-82.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J Bloomer, Doctorate principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Krill oil supplementation in people with Effects of Krill Oil on Human Health, run by University of Memphis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Lipids (time frame: Change from baseline at 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01378767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2011.