Effects of a Marine Protein Hydrolysate in Healthy Adults

NCT05149079 | Completed

• 1 other identifier: FHF-Study
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double blind, controlled trial investigates changes in the cardiovascular index (triacylglycerol/HDL-cholesterol × waist/hip ratio) after 12 weeks of marine protein hydrolysate (MPH) or whey protein powder (placebo) supplementation in adult healthy persons. Additionally, the study investigates potential effects on plasma parameters of metabolic health including lipids, glucose, inflammatory parameters and redox state, as well as associations between dietary MPH and body weight, abdominal obesity, body composition, and gut microbiota composition. Finally, putative end-products of diet-microbial interactions (TMAO and short-chain fatty acids) with CVD risk factors and biomarkers of mitochondrial function are examined.

Conditions

Healthy Diet

Keywords

Cardiovascular disease risk; Protein supplementation; Metabolic health

Outcome Measures

Primary Outcomes (1)

• Changes in the cardiovascular index (triacylglycerol/high density lipoprotein (HDL)-cholesterol × waist/hip ratio)

  Triacylclygerol and HDL-cholesterol concentrations will be measured in serum. Waist and hip circumference will be measured using anthropometric tape over light clothing. For waist circumference, the minimum circumference between the iliac crest and the rib cage will be used. For waist circumference the circumference at the level of the greatest protrusion of the buttocks is used.

  Baseline to 12 weeks

Secondary Outcomes (18)

• Changes in the Quick1 index, a surrogate marker of insulin sensitivity

  Baseline to 12 weeks

• Changes in fasting insulin

  Baseline to 12 weeks

• Changes in fasting insulin C-peptide

  Baseline to 12 weeks

• Changes in fasting glucose

  Baseline to 12 weeks

• Changes in total cholesterol

  Baseline to 12 weeks

Study Arms (2)

Placebo (whey protein supplement)

PLACEBO COMPARATOR

Participants will consume 18 g of the placebo whey protein supplement each day for 12 weeks.

Dietary Supplement: Placebo

Cod protein hydrolysate supplement

ACTIVE COMPARATOR

Participants will consume 18 g of the cod protein supplement each day for 12 weeks.

Dietary Supplement: Cod protein hydrolysate

Interventions

Cod protein hydrolysate DIETARY_SUPPLEMENT

Rest raw materials (RRM) from cod (Fjordlaks AS, Norway) are used for the hydrolysis production (Food Grade). Freshly minced RRM is treated wth enzymes optimized to generate bioactive hydrolysates using facilities and techniques approved for human consumption.

Cod protein hydrolysate supplement

Placebo DIETARY_SUPPLEMENT

Whey protein powder, commercially available

Also known as: Whey protein powder

Placebo (whey protein supplement)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female and male subjects at age 20-80 years old understanding Norwegian oral and written information
• Waist circumference for males \< 102 cm and females \< 88 cm

You may not qualify if:

• Pregnancy or lactation
• Having used high-dose omega-3 PUFA supplements (\>2 g/day) less than 28 days prior to randomization
• Use of corticosteroids that will influence protein metabolism
• Antibiotic treatment previous 3 months
• Alcohol or drug abuse or any conditions associated with poor compliance
• Medical diagnosis of malabsorption disorders, Crohn's disease, or lactose intolerance
• Scheduled hospitalization during the course of the study that could compromise the study
• Diabetes type I or II, serious high blood pressure at screening, serious infections, diseases requiring medication that can influence the study
• Known or suspected sensitivity or allergic reactions to the IMP or excipients
• Presence of other major medical or psychiatric illness that would affect the ability to participate in the study or put the subject at increased risk
• Intake of statins. If needed to obtain the recruitment goals, we will accept people using a low dose of statin

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator
• Alesund Hospital: collaborator
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Research Unit for Health Trials

Bergen, 5009, Norway

Location

Related Publications (2)

• Kim SK, Ngo DH, Vo TS. Marine fish-derived bioactive peptides as potential antihypertensive agents. Adv Food Nutr Res. 2012;65:249-60. doi: 10.1016/B978-0-12-416003-3.00016-0.

  PMID: 22361192 BACKGROUND

• Erdmann K, Cheung BW, Schroder H. The possible roles of food-derived bioactive peptides in reducing the risk of cardiovascular disease. J Nutr Biochem. 2008 Oct;19(10):643-54. doi: 10.1016/j.jnutbio.2007.11.010. Epub 2008 May 20.

  PMID: 18495464 BACKGROUND

Study Officials

• Rolf K Berge, PhD

  University of Bergen, Norway

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The groups will be randomly labelled A or B. Neither participants, care providers or statistician will know the treatments of the groups before the statistical analyses for the primary outcome have been completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double blind, placebo controlled clinical study

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: December 8, 2021
• Study Start: February 1, 2021
• Primary Completion: May 15, 2021
• Study Completion: May 31, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)