FISK4: A Study of the Effects of Intake of Two Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults

• Sponsor: University of Bergen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01894542
• Collaborator: Granit AS Transport & Tourism (Other), Norwegian Seafood Center (Other), Nofima (Other)
• Enrollment: 55
• Location: 1
• Arms: 3
• Duration (Months): 76
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity	Dietary Supplement: Cod protein from presscake; Dietary Supplement: Cod protein from presscake + stickwater; Dietary Supplement: Control	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cod protein from presscake	Dietary Supplement: Cod protein from presscake; 6g protein per day for 8wk
Experimental: Cod protein from presscake + stickwater	Dietary Supplement: Cod protein from presscake + stickwater; 6 g protein per day for 8 wk
Placebo Comparator: Control Control group will receive tablet containing only tablet fillers (the same as in the cod protein tablets).	Dietary Supplement: Control

Outcome Measures

Primary Outcome Measures

1. Glucose tolerance [8 weeks]

   Serum glucose will be measured in fasting and postprandial state

Secondary Outcome Measures

1. Gene expression [8 weeks]

   Changes in gene expression in adipose tissue related to the circulating markers of glucose regulation.

2. Amino acids and amino acid metabolites [8 weeks]

   Amino acids and amino acid metabolites will be measured in serum and urine

3. Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine [8 weeks]

   Concentrations of relevant metabolites and co-factors were measured in serum and urine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Bergen	Bergen		Norway

Sponsors and Collaborators

• University of Bergen
• Granit AS Transport & Tourism
• Norwegian Seafood Center
• Nofima

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Oddrun Anita Gudbrandsen, PhD, University of Bergen
• ClinicalTrials.gov Identifier: NCT01894542
• Other Study ID Numbers: 2011/572-14
• First Posted: Jul 10, 2013
• Last Update Posted: Apr 7, 2022
• Last Verified: Mar 1, 2022

• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Apr 7, 2022