Health Effects of Salmon Fishmeal in Humans

University of Oslo88 enrolled

Overview

Diabetes contributes significantly to the burden of disease in Norway and cardiovascular disease is the main cause of mortality. Both lean and fatty fish are shown to have beneficial health effects. In addition to omega-3 fatty acids, fish contain potential health-promoting components such as taurine, vitamin D, vitamin B12, iodine, selenium and more unspecified components such as bioactive peptides. With the expected growth in the aquaculture sector, more protein-rich by-products will become available. The overall aim of this project is to investigate the health beneficial effects of fish protein in the form of salmon fishmeal in a human intervention study with regard to metabolic risk markers. We will include subjects with impaired glucose tolerance to a randomized controlled parallel study. The subjects will receive capsules with fishmeal or placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Impaired Glucose Tolerance

Interventions

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Fasting plasma glucose ≥ 5.6 mmol/l or * Plasma glucose ≥ 6.5 mmol/l 2h after an OGTT or * HbA1c ≥ 5.8 % Exclusion criteria: * Diabetes (defined as p-glucose ≥ 7.0 mmol/l p-glucose ≥11,1 mmol/l 2h after OGTT or HbA1c ≥ 6.5 %) * High fish intake (\> 450 gram/week) or fish allergy * Age-related elevated blood pressure (≥ 70 år: ≥ 180/110 mmHg, \> 40-70: ≥ 170/100 mmHg and ≤ 40 år: ≥ 160/100 mmHg) * Use of prescription medicines related to diabetes, inflammation, systemic use of corticosteroids. * Non-stable use of lipid lowering drugs, thyroxine, blood pressure lowering drugs, drugs affecting appetite, dietary supplements (including n-3) * High intake of protein supplements powder * Pregnancy * Planning pregnancy or changes in body weight

Outcomes

Primary Outcomes

2 hour postprandial blood glucose concentration

Glucose concentration measured before and after a standard glucose tolerance test at baseline and after 8 weeks

Time frame: Change in 2 hour blood glucose concentration from baseline and after 8 weeks between groups

Fasting blood glucose concentration

Measured at baseline and after 8 weeks.

Time frame: Change in blood glucose concentration from baseline and after 8 weeks between groups

Secondary Outcomes

Blood concentration of insulin

Blood concentration measured fasting and 2 hours after an oral glucose tolerance test

Time frame: Changes in blood insulin concentration from baseline and after 8 weeks between groups

HOMA-IR

Blood concentration of insulin x blood concentration of glucose will be used to calculate HOMAR-IR fasting and 2 hours after an oral glucose tolerance test

Time frame: Changes in HOMAR-IR from baseline and after 8 weeks between groups

Blood concentration of HbA1c

Blood concentration measured fasting

Time frame: Changes in blood HbA1c concentration from baseline and after 8 weeks between groups

Blood concentration of incretins (i.e. GLP-1)

Blood concentration of incretins measured fasting and 2 hours after oral glucose tolerance test

Time frame: Changes in blood glucose concentration of increstins from baseline and after 8 weeks between groups