Clinical trial NCT01378767: Health Benefits of a 21-day Daniel Fast
Official title: Biochemical, Hemodynamic, and Anthropometric Effects of a 21-day Daniel Fast in Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of Krill Oil on Human Health
Keywords: Dietary restriction
oxidative stress
fasting
Lead sponsor: University of Memphis
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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)

Primary outcomes:
measure: Blood Lipids
timeFrame: Change from baseline at 3 weeks
measure: Glucoregulatory markers
timeFrame: Change from baseline at 3 weeks
measure: Markers of Oxidative Stress and Antioxidant Status
timeFrame: Change from baseline at 3 weeks
measure: Blood Pressure
timeFrame: Change from baseline at 3 weeks
measure: C-reactive protein
timeFrame: Change from baseline at 3 weeks
Secondary outcomes:
measure: Anthropometric Variables
timeFrame: Change from baseline at 3 weeks
measure: Metabolic Panel
timeFrame: Change from baseline at 3 weeks
measure: Complete Blood Count
timeFrame: Change from baseline at 3 weeks
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Cardiorespiratory/Metabolic Laboratory
state: Tennessee
Study officials:
affiliation: University of Memphis
name: Richard J Bloomer, Doctorate
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.