NCT01378767

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 22, 2011

Completed
Last Updated

June 22, 2011

Status Verified

June 1, 2011

Enrollment Period

3 months

First QC Date

June 10, 2011

Last Update Submit

June 20, 2011

Conditions

Keywords

Dietary restrictionoxidative stressfasting

Outcome Measures

Primary Outcomes (5)

  • Blood Lipids

    Total Cholesterol, LDL-C, HDL-C, VLDL-C, Triglyerides

    Change from baseline at 3 weeks

  • Glucoregulatory markers

    Blood glucose, blood insulin, Serum resistin, serum adiponectin

    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)

    Change from baseline at 3 weeks

  • Blood Pressure

    Systolic blood pressure, diastolic blood pressure

    Change from baseline at 3 weeks

  • C-reactive protein

    Change from baseline at 3 weeks

Secondary Outcomes (3)

  • Anthropometric Variables

    Change from baseline at 3 weeks

  • Metabolic Panel

    Change from baseline at 3 weeks

  • Complete Blood Count

    Change from baseline at 3 weeks

Study Arms (2)

Krill oil capsules

ACTIVE COMPARATOR

Two grams per day daily for 21 days

Dietary Supplement: Krill oil supplementation

Coconut oil capsules

PLACEBO COMPARATOR

Two grams per day for 21 days

Dietary Supplement: Krill oil supplementation

Interventions

Krill oil supplementationDIETARY_SUPPLEMENT

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).

Also known as: 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
Coconut oil capsulesKrill oil capsules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiorespiratory/Metabolic Laboratory

Memphis, Tennessee, 38152, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Richard J Bloomer, Doctorate

    University of Memphis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2011

First Posted

June 22, 2011

Study Start

September 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 22, 2011

Record last verified: 2011-06

Locations