Effects of Chicken Protein Hydrolysate (CPH) Supplementation in People With High Waist Circumference

NCT05149092 | Completed

• 1 other identifier: CPH-Study
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized, placebo controlled, double blind trial, effects of relatively high doses of chicken protein hydrolysate (CPH) or casein hydrolysate (placebo) supplementation will be investigate in healthy persons with abdominal obesity. The 12-week study examines potential effects on body weight, abdominal obesity, body composition, plasma parameters of metabolic health including lipids, inflammatory parameters, redox state and microbiota biomarkers.

Conditions

Abdominal Obesity

Keywords

Cardiovascular disease risk; Protein supplementation; Metabolic health

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in waist circumference in the CPH group as compared to placebo/casein at week 12

  Waist 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.

  At baseline visit and end visit (week 12)

Secondary Outcomes (24)

• Changes from baseline in glucagon-like peptide 1 (GLP-1, hormone involved in appetite and metabolism regulation) in the CPH group as compared to placebo/casein

  At baseline visit and end visit (week 12)

• Changes from baseline in gastric inhibitory polypeptide (GIP, hormone involved in metabolism regulation) in the CPH group as compared to placebo/casein

  At baseline visit and end visit (week 12)

• Changes from baseline in ghrelin (hormone involved in appetite regulation) in the CPH group as compared to placebo/casein

  At baseline visit and end visit (week 12)

• Changes from baseline in heart rate in the CPH group as compared to placebo/casein

  At baseline visit and end visit (week 12)

• Changes from baseline in blood pressure in the CPH group as compared to placebo/casein

  At baseline visit and end visit (week 12)

Study Arms (2)

Placebo (casein protein supplement)

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Chicken protein hydrolysate supplement

ACTIVE COMPARATOR

Dietary Supplement: Chicken protein hydrolysate supplement

Interventions

Chicken protein hydrolysate supplement DIETARY_SUPPLEMENT

Daily oral self-administration of 18 g of supplement dissolved in water/mineral water, spread over 2-3 occasions

Also known as: CPH

Chicken protein hydrolysate supplement

Placebo DIETARY_SUPPLEMENT

Daily oral self-administration of 18 g of supplement dissolved in water/mineral water, spread over 2-3 occasions

Also known as: Casein

Placebo (casein 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:

• Female and male subjects at least 20 years old understanding Norwegian oral and written information
• Waist circumference of:
• Men \> 95 cm
• Women \> 81 cm

You may not qualify if:

• Pregnancy
• Having used high-dose omega-3 PUFA supplements (\>2 g/day) 28 days' prior to randomization
• Alcohol or drug abuse or any conditions associated with poor compliance
• Scheduled hospitalization during the course of the study that could compromise the study
• Major diseases or infections including chronic diseases
• 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. Simvastatin 10 mg or Pravastatin 10-20 mg will be accepted, but not higher doses or the drugs Lipitor/Atorvastatin and Crestor/Rosuvastatin.

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator
• Norilia AS: collaborator

Study Sites (1)

Research Unit for Health Trials

Bergen, 5009, Norway

Location

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Caseins

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoproteins

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: December 8, 2021
• Study Start: January 18, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)