Effects of Chicken Protein Hydrolysate (CPH) Supplementation in People With High Waist Circumference (CHICKPEP)
Primary Purpose
Abdominal Obesity
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Chicken protein hydrolysate supplement
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Obesity focused on measuring Cardiovascular disease risk, Protein supplementation, Metabolic health
Eligibility Criteria
Inclusion Criteria:
- Female and male subjects at least 20 years old understanding Norwegian oral and written information
Waist circumference of:
- Men > 95 cm
- Women > 81 cm
Exclusion Criteria:
- 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.
Sites / Locations
- Research Unit for Health Trials
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo (casein protein supplement)
Chicken protein hydrolysate supplement
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Measured in plasma using immunological methods (ELISA). All plasma samples will be kept on ice directly after collection, and relevant inhibitors will be added.
Changes from baseline in gastric inhibitory polypeptide (GIP, hormone involved in metabolism regulation) in the CPH group as compared to placebo/casein
Measured in plasma using immunological methods (ELISA). All plasma samples will be kept on ice directly after collection, and relevant inhibitors will be added.
Changes from baseline in ghrelin (hormone involved in appetite regulation) in the CPH group as compared to placebo/casein
Measured in plasma using immunological methods (ELISA). All plasma samples will be kept on ice directly after collection, and relevant inhibitors will be added.
Changes from baseline in heart rate in the CPH group as compared to placebo/casein
The heart rate will be registered after 5 minutes of supine rest using a Schiller BP-200
Changes from baseline in blood pressure in the CPH group as compared to placebo/casein
The blood pressure will be registered after 5 minutes of supine rest using a blood pressure monitor.
Changes from baseline in waist/hip ratio in the CPH group as compared to placebo/casein
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 hip circumference, the maximum measurement over the great trochanters will be used.
Changes from baseline in waist/height ratio in the CPH group as compared to placebo/casein
Height will be measured with a wall-mounted stadiometer. Waist circumference will be measured using anthropometric tape over light clothing. The minimum circumference between the iliac crest and the rib cage will be used.
Changes from baseline in the Quick1 surrogate marker forinsulin sensitivity in the CPH group as compared to placebo/casein
Glucose and insulin will be measured in serum by routine laboratories. Quick1 will be calculated by 1 / (log(fasting insulin μU/mL) + log(fasting glucose mg/dL)
Changes from baseline in serum glucose in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Changes from baseline in serum insulin c-peptide in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Changes from baseline in serum insulin in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Changes from baseline in serum total cholesterol in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Changes from baseline in serum triacylglycerol (TAG) in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Change from baseline in serum non-esterified fatty acids (NEFA) in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Change from baseline in serum non-HDL cholesterol in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Change from baseline in serum CRP in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Change from baseline in serum HDL cholesterol/LDL cholesterol size ratio in the CPH group as compared to placebo/casein
Lipoprotein profile will be analysed by exclusion gel chromatography.
Change from baseline in serum ceramides in the CPH group as compared to placebo/casein
The ceramides in plasma will be analysed by LC-MS.
Change from baseline in fat mass/fat-free mass ratio in the CPH group as compared to placebo/casein
Bioelectrical impedance measurement will be used for the assessment of body composition.
Changes in antioxidant capacity in the CPH group as compared to placebo/casein at week 12
Measured in plasma by a commercial kit (Sigma Aldrich, MAK187)
Changes in serum acetylcarnitine/palmitoylcarnitine ratio in the CPH group as compared to placebo/casein at week 12
Short-, medium-, and long-chain acylcarnitines, will be analysed in serum using LC/MS/MS.
Changes in serum octanoylcarnitine in the CPH group as compared to placebo/casein at week 12
Plasma choline, betaine, free carnitine and its precursors: trimethyllysine and γ-butyrobetaine, as well as short-, medium-, and long-chain acylcarnitines, will be analysed in serum using LC/MS/MS. Stable isotope dilution LC/MS/MS will be used for quantification of trimethylamine oxide (TMAO), dimethylglycine (DMG), choline and betaine. Plasma metabolites of the TCA cycle and amino acids-kynurenine-nicotinamide pathway will be measured by LC-MS.
Changes in serum TMAO (trimethylamine N-oxide) in the CPH group as compared to placebo/casein at week 12
Stable isotope dilution LC/MS/MS will be used for quantification of trimethylamine oxide (TMAO).
Changes from baseline in the serum anti-inflammatory fatty acid index in the CPH group as compared to placebo at Week 12.
Fatty acid composition will be analysed using GC/MS. The anti-inflammatory fatty acid index is calculated as ((C22:5n-3 + C22:6n-3 + C20:3n-6 + C20:5n-3)/C20:4n-6)*100
Full Information
NCT ID
NCT05149092
First Posted
March 9, 2021
Last Updated
November 25, 2021
Sponsor
University of Bergen
Collaborators
Haukeland University Hospital, Norilia AS
1. Study Identification
Unique Protocol Identification Number
NCT05149092
Brief Title
Effects of Chicken Protein Hydrolysate (CPH) Supplementation in People With High Waist Circumference
Acronym
CHICKPEP
Official Title
Randomized, Double Blind, Placebo Controlled Study to Investigate the Effect of Chicken Protein Hydrolysates (CPH) in Persons With High Waist Circumference
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bergen
Collaborators
Haukeland University Hospital, Norilia AS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Small peptides in the range of 2 - 12 amino acids are believed to cross the intestinal wall undigested and enter the circulation where they can have a range of activities based on their amino acid composition and structure. Natural peptides isolated from a number of food proteins, including plants and marine organisms, are shown to have antioxidant effects in in vitro tests, and anti-hypertensive effects in mice through inhibition of the angiotensin-converting-enzyme (ACE). Protein hydrolysates from both animal- and plant-based sources will consist of a mixture of potentially bioactive peptides that can have specific effects based on their composition. Studies have shown that egg- and soy-derived hydrolysates have anti-diabetic and anti-obesity properties in rodents. Pre-clinical studies in mice have demonstrated potent plasma cytokine lowering abilities and atherosclerosis-prevention by chicken protein hydrolysate (CPH) diets, as well as effects on plasma cholesterol level, cytokines and lipid metabolism, including mitochondrial function. In addition, an isolated peptide fraction from chicken inhibits the dipeptyl peptidase IV, and thus has the potential to restore glucose homeostasis in type 2 diabetics.
The hydrolysate supplements used in this study are obtained from rest raw materials (RRM) from mechanical deboning of chicken meat (Food Grade, Nortura AS Hærland, Norway). Freshly minced chicken RRM has been treated with enzymes optimized to generate bioactive hydrolysates. The supplement is given in a dose of 18 g protein per day, corresponding to the protein content of a standard meal, and similar to doses recommended in protein shake supplements.
Around 60 males and females age >20 years with abdominal obesity participate, recruited primarily through social media advertisements (Facebook) limited to a 12 km radius around the city center of Bergen. Participants provided written informed consent, and were screened via self-reporting in an online form in EasyTrial hosted by the Research Unit for Clinical Trials at the University of Bergen. Data collection by the study staff at baseline verifies inclusion and exclusion criteria and participant eligibility prior to randomization. The potential participants are informed about practical details at a digital or physical meeting 1-2 weeks prior to baseline.
Groups of participants (40-60% males/females) are block randomized to the two treatments (CPH or placebo casein supplementation) using randomly selected block sizes, and stratified according to sex.
The participants are given a container with the powder sufficient for the entire 12-week study period, and a spoon to measure the intake at breakfast (6 g), lunch (6 g) and supper (6 g), or morning (9 g) and evening (9 g) according to individual preference. The patients will mix the powder products in water or mineral water.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity
Keywords
Cardiovascular disease risk, Protein supplementation, Metabolic health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo (casein protein supplement)
Arm Type
Placebo Comparator
Arm Title
Chicken protein hydrolysate supplement
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Chicken protein hydrolysate supplement
Other Intervention Name(s)
CPH
Intervention Description
Daily oral self-administration of 18 g of supplement dissolved in water/mineral water, spread over 2-3 occasions
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Casein
Intervention Description
Daily oral self-administration of 18 g of supplement dissolved in water/mineral water, spread over 2-3 occasions
Primary Outcome Measure Information:
Title
Changes from baseline in waist circumference in the CPH group as compared to placebo/casein at week 12
Description
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.
Time Frame
At baseline visit and end visit (week 12)
Secondary Outcome Measure Information:
Title
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
Description
Measured in plasma using immunological methods (ELISA). All plasma samples will be kept on ice directly after collection, and relevant inhibitors will be added.
Time Frame
At baseline visit and end visit (week 12)
Title
Changes from baseline in gastric inhibitory polypeptide (GIP, hormone involved in metabolism regulation) in the CPH group as compared to placebo/casein
Description
Measured in plasma using immunological methods (ELISA). All plasma samples will be kept on ice directly after collection, and relevant inhibitors will be added.
Time Frame
At baseline visit and end visit (week 12)
Title
Changes from baseline in ghrelin (hormone involved in appetite regulation) in the CPH group as compared to placebo/casein
Description
Measured in plasma using immunological methods (ELISA). All plasma samples will be kept on ice directly after collection, and relevant inhibitors will be added.
Time Frame
At baseline visit and end visit (week 12)
Title
Changes from baseline in heart rate in the CPH group as compared to placebo/casein
Description
The heart rate will be registered after 5 minutes of supine rest using a Schiller BP-200
Time Frame
At baseline visit and end visit (week 12)
Title
Changes from baseline in blood pressure in the CPH group as compared to placebo/casein
Description
The blood pressure will be registered after 5 minutes of supine rest using a blood pressure monitor.
Time Frame
At baseline visit and end visit (week 12)
Title
Changes from baseline in waist/hip ratio in the CPH group as compared to placebo/casein
Description
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 hip circumference, the maximum measurement over the great trochanters will be used.
Time Frame
At baseline visit and end visit (week 12)
Title
Changes from baseline in waist/height ratio in the CPH group as compared to placebo/casein
Description
Height will be measured with a wall-mounted stadiometer. Waist circumference will be measured using anthropometric tape over light clothing. The minimum circumference between the iliac crest and the rib cage will be used.
Time Frame
At baseline visit and end visit (week 12)
Title
Changes from baseline in the Quick1 surrogate marker forinsulin sensitivity in the CPH group as compared to placebo/casein
Description
Glucose and insulin will be measured in serum by routine laboratories. Quick1 will be calculated by 1 / (log(fasting insulin μU/mL) + log(fasting glucose mg/dL)
Time Frame
At baseline visit and end visit (week 12)
Title
Changes from baseline in serum glucose in the CPH group as compared to placebo/casein
Description
Will be measured in serum by routine laboratories
Time Frame
At baseline visit and end visit (week 12)
Title
Changes from baseline in serum insulin c-peptide in the CPH group as compared to placebo/casein
Description
Will be measured in serum by routine laboratories
Time Frame
At baseline visit and end visit (week 12)
Title
Changes from baseline in serum insulin in the CPH group as compared to placebo/casein
Description
Will be measured in serum by routine laboratories
Time Frame
At baseline visit and end visit (week 12)
Title
Changes from baseline in serum total cholesterol in the CPH group as compared to placebo/casein
Description
Will be measured in serum by routine laboratories
Time Frame
At baseline visit and end visit (week 12)
Title
Changes from baseline in serum triacylglycerol (TAG) in the CPH group as compared to placebo/casein
Description
Will be measured in serum by routine laboratories
Time Frame
At baseline visit and end visit (week 12)
Title
Change from baseline in serum non-esterified fatty acids (NEFA) in the CPH group as compared to placebo/casein
Description
Will be measured in serum by routine laboratories
Time Frame
At baseline visit and end visit (week 12)
Title
Change from baseline in serum non-HDL cholesterol in the CPH group as compared to placebo/casein
Description
Will be measured in serum by routine laboratories
Time Frame
At baseline visit and end visit (week 12)
Title
Change from baseline in serum CRP in the CPH group as compared to placebo/casein
Description
Will be measured in serum by routine laboratories
Time Frame
At baseline visit and end visit (week 12)
Title
Change from baseline in serum HDL cholesterol/LDL cholesterol size ratio in the CPH group as compared to placebo/casein
Description
Lipoprotein profile will be analysed by exclusion gel chromatography.
Time Frame
At baseline visit and end visit (week 12)
Title
Change from baseline in serum ceramides in the CPH group as compared to placebo/casein
Description
The ceramides in plasma will be analysed by LC-MS.
Time Frame
At baseline visit and end visit (week 12)
Title
Change from baseline in fat mass/fat-free mass ratio in the CPH group as compared to placebo/casein
Description
Bioelectrical impedance measurement will be used for the assessment of body composition.
Time Frame
At baseline visit and end visit (week 12)
Title
Changes in antioxidant capacity in the CPH group as compared to placebo/casein at week 12
Description
Measured in plasma by a commercial kit (Sigma Aldrich, MAK187)
Time Frame
At baseline visit and end visit (week 12)
Title
Changes in serum acetylcarnitine/palmitoylcarnitine ratio in the CPH group as compared to placebo/casein at week 12
Description
Short-, medium-, and long-chain acylcarnitines, will be analysed in serum using LC/MS/MS.
Time Frame
At baseline visit and end visit (week 12)
Title
Changes in serum octanoylcarnitine in the CPH group as compared to placebo/casein at week 12
Description
Plasma choline, betaine, free carnitine and its precursors: trimethyllysine and γ-butyrobetaine, as well as short-, medium-, and long-chain acylcarnitines, will be analysed in serum using LC/MS/MS. Stable isotope dilution LC/MS/MS will be used for quantification of trimethylamine oxide (TMAO), dimethylglycine (DMG), choline and betaine. Plasma metabolites of the TCA cycle and amino acids-kynurenine-nicotinamide pathway will be measured by LC-MS.
Time Frame
At baseline visit and end visit (week 12)
Title
Changes in serum TMAO (trimethylamine N-oxide) in the CPH group as compared to placebo/casein at week 12
Description
Stable isotope dilution LC/MS/MS will be used for quantification of trimethylamine oxide (TMAO).
Time Frame
At baseline visit and end visit (week 12)
Title
Changes from baseline in the serum anti-inflammatory fatty acid index in the CPH group as compared to placebo at Week 12.
Description
Fatty acid composition will be analysed using GC/MS. The anti-inflammatory fatty acid index is calculated as ((C22:5n-3 + C22:6n-3 + C20:3n-6 + C20:5n-3)/C20:4n-6)*100
Time Frame
At baseline visit and end visit (week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female and male subjects at least 20 years old understanding Norwegian oral and written information
Waist circumference of:
Men > 95 cm
Women > 81 cm
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf K Berge, PhD
Organizational Affiliation
University of Bergen, Norway
Official's Role
Study Director
Facility Information:
Facility Name
Research Unit for Health Trials
City
Bergen
ZIP/Postal Code
5009
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Chicken Protein Hydrolysate (CPH) Supplementation in People With High Waist Circumference
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