A Study of the Effects of Intake of Two Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults

Obesity Clinical Trial

— FISK4  

Official title:

An 8 Week Study to Compare the Effects of Two Combinations of Water Soluble and Non-water Soluble Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894542
• Other study ID #: 2011/572-14
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: December 2019

Study information

• Verified date: March 2022
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators have previously shown the intact protein from cod filet improves glucose regulation and serum lipid profile in overweight adults. A large amount of trimmings from various fish species such as cod is thrown away or sold at very low prices for animal feed, and analyses of the amino acid composition reveals that this can be a good protein source for humans. Two fractions are normally isolated from intact fish meal, i.e. water soluble and non-water soluble proteins. In the present study the investigators will compare these fractions, by studying their effects on glucose regulation in overweight/obese adults.

Description:

Participants receive 6g per day of water soluble on non-water soluble cod protein as tablets for 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2019
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI>28

• healthy

• fasting blood glucose <7.0 mmol/L

• stable body weight with less than 5 kg fluctuation during the last 4 months

Exclusion Criteria:

• known disease or metabolic disturbances related to overweight or obesity

• use of prescription medications that affect blood glucose, blood lipids or inflammatory status

• allergies towards fish or seafood

• undertaking a weight loss diet

• tobacco use exceeding >15 cigarettes/day

• pregnancy or breastfeeding

• high seafood consumption

• use of dietary supplements including cod liver oil or other marine fatty acids

• allergies towards fish, milk, egg

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Cod protein from presscake
6g protein per day for 8wk
• Cod protein from presscake + stickwater
6 g protein per day for 8 wk
• Control

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen

Sponsors (4)

Lead Sponsor	Collaborator
University of Bergen	Granit AS Transport & Tourism, Nofima, Norwegian Seafood Center

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Vikøren LA, Nygård OK, Lied E, Rostrup E, Gudbrandsen OA. A randomised study on the effects of fish protein supplement on glucose tolerance, lipids and body composition in overweight adults. Br J Nutr. 2013 Feb 28;109(4):648-57. doi: 10.1017/S0007114512001717. Epub 2012 May 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose tolerance	Serum glucose will be measured in fasting and postprandial state	8 weeks
Secondary	Gene expression	Changes in gene expression in adipose tissue related to the circulating markers of glucose regulation.	8 weeks
Secondary	Amino acids and amino acid metabolites	Amino acids and amino acid metabolites will be measured in serum and urine	8 weeks
Secondary	Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine	Concentrations of relevant metabolites and co-factors were measured in serum and urine	8 weeks