Safety and Tolerability of Krill Powder Supplement in Slightly Overweight People With Moderately Elevated Blood Pressure

NCT03112083 | Completed

• 1 other identifier: OP001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to systematically collect data on safety and tolerability of krill powder in humans and simultaneously gain efficacy data by measuring the risk factors for cardiovascular disease. The study was a randomised, double-blinded, placebo-controlled intervention study with slightly obese subjects with mildly or moderately elevated blood pressure. Study was conducted at two study sites in Central (Tampere) and Northern Finland (Oulu). In total 35 subjects were randomised according to randomisation list to two groups (krill powder or placebo) in a balanced manner (1:1), separately for both gender and site. Concealed allocation was used to keep both subjects and staff blinded. The study consisted of a pre-screening, Day -7-(-14) screening visit, Day 0 baseline (Randomization visit) and 8-week safety and tolerance follow-up period with three follow-up visits on Day 14, Day 28 and Day 56. As a primary endpoint of the study, the total number of reported adverse events were compared in the study subject groups taking 8 capsules (4 g) krill oil powder or 8 capsules (4 g) of placebo for the 8-week follow-up period.

Conditions

Adverse Drug Event; Side Effects of Drugs

Keywords

krill powder; krill oil; safety; tolerability; adverse event; omega-3 fatty acids; eicosapentaenoic acid; docosahexaenoic acid

Outcome Measures

Primary Outcomes (1)

• Change in Adverse events

  Total number of reported adverse events

  Screening, baseline, day 28, day 56

Secondary Outcomes (15)

• Type of adverse event

  Screening, baseline, day 28, day 56

• Change in Systolic blood pressure

  Screening, baseline, day 28, day 56

• Change in Diastolic blood pressure

  Screening, baseline, day 28, day 56

• Change in thyrotropin

  Screening, baseline, day 28, day 56

• Change in Alanine transaminase (ALT)

  Screening, baseline, day 28, day 56

Study Arms (2)

Krill oil

ACTIVE COMPARATOR

Krill powder capsules, 4 g

Dietary Supplement: Nutritional counseling A

Placebo

PLACEBO COMPARATOR

Placebo capsules, maize strach, 4 g

Dietary Supplement: Nutritional counselling B

Interventions

Nutritional counseling A DIETARY_SUPPLEMENT

Krill powder capsules

Krill oil

Nutritional counselling B DIETARY_SUPPLEMENT

Placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• Slightly obese female and male subjects (BMI between 25-30 kg/ m2)
• Mildly or moderately elevated blood pressure (RR systolic 130-159/ diastolic under 99)
• Signed written informed consent

You may not qualify if:

• Medication potential to affect serum lipids (lipid-lowering drugs)
• Familial hypercholesterolemia, marked combined hyperlipidemia, condition that would impair fat absorption (e.g. chronic pancreatitis, pancreatic lipase deficiency syndrome)
• Any untreated medical condition affecting absorption of fat
• Type 1 and 2 diabetes
• Cancer or other malignant disease within the past five years
• Periodical hormone replacement therapy
• High intake of oily fish (\>2 times per week as a principal meal) (i.e. salmon, herring, sardines, mackerel, vendace)
• Smoking
• Alcohol consumption \>15 doses per week
• Pregnant, lactating or wish to become pregnant
• Hypersensitivity to fish or any of the components of the test products
• Regular use (\> 3 times per week) of n-3 or other fatty acid supplements, plant sterols or fiber supplements 4 weeks before randomization
• Lack of suitability for participation in the trial, for any medical reason, as judged by the PI

Sponsors & Collaborators

• Olympic Seafood AS: lead

Study Sites (1)

Oy Medfiles Ltd

Kuopio, 70701, Finland

Location

Related Publications (1)

• Sarkkinen ES, Savolainen MJ, Taurio J, Marvola T, Bruheim I. Prospective, randomized, double-blinded, placebo-controlled study on safety and tolerability of the krill powder product in overweight subjects with moderately elevated blood pressure. Lipids Health Dis. 2018 Dec 20;17(1):287. doi: 10.1186/s12944-018-0935-x.

  PMID: 30572894 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: two parallel groups (placebo and Krill oil), intervention trial (56 days)

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 13, 2017
• Study Start: October 6, 2015
• Primary Completion: June 17, 2016
• Study Completion: June 17, 2016
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)