Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000106639
Ethics application status
Approved
Date submitted
10/01/2023
Date registered
31/01/2023
Date last updated
31/01/2023
Date data sharing statement initially provided
31/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a dairy protein (whey) hydrolysate on blood sugar, metabolic rate, gut and immune function after eating.
Scientific title
Acute effects of a dairy protein (whey) hydrolysate on postprandial metabolism in healthy adults: glycaemia, thermogenesis, gut barrier function, immune/inflammation
Secondary ID [1] 308395 0
None
Universal Trial Number (UTN)
U1111-1284-8906
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial hyperglycaemia 328193 0
Diet-induced thermogenesis 328194 0
Gut barrier function 328195 0
Immune function 328196 0
Condition category
Condition code
Metabolic and Endocrine 325245 325245 0 0
Normal metabolism and endocrine development and function
Inflammatory and Immune System 325246 325246 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Hydrolysed whey protein (~300mL and 25g protein)
Arm 2: Intact whey protein (~300mL and 25g protein)

This study is an acute cross-over trial lasting 6 hours for each study visit. There will be 3 Study Visits in total (including the Control arm), each Study Visit is at least 2 days apart.

The evening before Study Visit, participants will be required to consume a standardised meal at home between 7 - 8 pm. The standardised meal may be given as either pies or mac & cheese, both are higher in fat content. Participants are not allowed to eat any other foods or beverages (except water) since 7 pm until the Study Visit on the following day. Adherence to the consumption of standardised evening meals overnight fasting will be based on self-report prior to any clinical procedures during the Study Visit day.

At each Study Visit, participants will arrive at the Human Nutrition Unit, University of Auckland in the morning, after an overnight fast. Participants will receive one of the test beverages (hydrolysed whey protein, intact whey protein, or water control) which they must consume in full within 5 - 10 minutes, under the supervision of research staff. 30 minutes later, participants will receive a standardised higher carbohydrate and higher fat breakfast pastry meal which they must consume in full within 10 minutes, under the supervision of research staff. 3.5 hours after the breakfast pastry meal, participants will be presented with a pasta and tomato meat sauce lunch meal in a dining room whereby they will be advised to eat freely until comfortably full. Participants will be required to remain seated in the dining room for 30 minutes until the lunch session is complete.
Intervention code [1] 324851 0
Prevention
Intervention code [2] 325210 0
Treatment: Other
Comparator / control treatment
Iso-volumetric water (~300mL and 0g protein) will be used as a negative control in place of hydrolysed whey protein or intact whey protein. Flavourings added to the whey protein beverages will also be added to the water.
Control group
Placebo

Outcomes
Primary outcome [1] 333100 0
Plasma glucose
Timepoint [1] 333100 0
Baseline, t = -45 and -15min
Post-ingestion of whey protein, t = 15 and 30 min
Post-ingestion of mixed meal test, t = 45, 60, 90, 120, 180, and 210 min
Post-ingestion of lunch, t = 250 and 280 min
Secondary outcome [1] 415792 0
Energy expenditure measured by indirect calorimetry
Timepoint [1] 415792 0
Continuously baseline, t = -45 to -15min
Continuously post-ingestion of whey protein, t = 0 to 30 min
Continuously post-ingestion of mixed meal test, t = 45 to 210 min
Secondary outcome [2] 415793 0
Plasma insulin
Timepoint [2] 415793 0
Baseline, t = -45 and -15min
Post-ingestion of whey protein, t = 15 and 30 min
Post-ingestion of mixed meal test, t = 45, 60, 90, 120, 180, and 210 min
Post-ingestion of lunch, t = 250 and 280 min
Secondary outcome [3] 415794 0
Plasma cytokines (exploratory outcome)
Timepoint [3] 415794 0
Baseline, t = -45 and -15min
Post-ingestion of whey protein, t = 15 and 30 min
Post-ingestion of mixed meal test, t = 45, 60, 90, 120, 180, and 210 min
Post-ingestion of lunch, t = 250 and 280 min
Secondary outcome [4] 415795 0
Serum lipid profile
Timepoint [4] 415795 0
Baseline, t = -45 and -15min
Post-ingestion of whey protein, t = 15 and 30 min
Post-ingestion of mixed meal test, t = 45, 60, 90, 120, 180, and 210 min
Post-ingestion of lunch, t = 250 and 280 min
Secondary outcome [5] 415796 0
Plasma calcium
Timepoint [5] 415796 0
Baseline, t = -45 and -15min
Post-ingestion of whey protein, t = 15 and 30 min
Post-ingestion of mixed meal test, t = 45, 60, 90, 120, 180, and 210 min
Post-ingestion of lunch, t = 250 and 280 min
Secondary outcome [6] 415797 0
Serum/Plasma Lipopolysaccharide-binding protein
Timepoint [6] 415797 0
Baseline, t = -45 and -15min
Post-ingestion of whey protein, t = 15 and 30 min
Post-ingestion of mixed meal test, t = 45, 60, 90, 120, 180, and 210 min
Post-ingestion of lunch, t = 250 and 280 min
Secondary outcome [7] 415798 0
Serum hs-CRP
Timepoint [7] 415798 0
Baseline, t = -45 and -15min
Post-ingestion of whey protein, t = 15 and 30 min
Post-ingestion of mixed meal test, t = 45, 60, 90, 120, 180, and 210 min
Post-ingestion of lunch, t = 250 and 280 min
Secondary outcome [8] 415799 0
Whole blood or plasma antioxidant status (exploratory outcome)
Timepoint [8] 415799 0
Baseline, t = -45 and -15min
Post-ingestion of whey protein, t = 15 and 30 min
Post-ingestion of mixed meal test, t = 45, 60, 90, 120, 180, and 210 min
Post-ingestion of lunch, t = 250 and 280 min
Secondary outcome [9] 415800 0
Blood pressure as assessed using a digital sphygmomanometer
Timepoint [9] 415800 0
Baseline, t = -15min
Post-ingestion of whey protein, t = 30 min
Post-ingestion of mixed meal test, t = 90, 180, and 210 min
Post-ingestion of lunch, t = 250 and 280 min
Secondary outcome [10] 415801 0
Heart rate as assessed using a wireless chest strap monitor
Timepoint [10] 415801 0
Continuously at baseline, t = -45 and -15min (when measuring resting energy expenditure)
Continuously post-ingestion of whey protein, t = 0 to 30 min
Continuously post-ingestion of mixed meal test, t = 45 to 210 min
Secondary outcome [11] 415802 0
Appetite assessed via Visual Analogue Scale (VAS)
Timepoint [11] 415802 0
Baseline, t = -45 and -15 min
Post-ingestion of whey protein, t = 15 and 30 min
Post-ingestion of mixed meal test, t = 45, 60, 75, 90, 120, 150, 180 and 210 min
Post-ingestion of lunch, t = 250 and 280 min
Secondary outcome [12] 417509 0
Plasma C-Peptide
Timepoint [12] 417509 0
Baseline, t = -45 and -15min
Post-ingestion of whey protein, t = 15 and 30 min
Post-ingestion of mixed meal test, t = 45, 60, 90, 120, 180, and 210 min
Post-ingestion of lunch, t = 250 and 280 min
Secondary outcome [13] 417510 0
Plasma GIP
Timepoint [13] 417510 0
Baseline, t = -45 and -15min
Post-ingestion of whey protein, t = 15 and 30 min
Post-ingestion of mixed meal test, t = 45, 60, 90, 120, 180, and 210 min
Post-ingestion of lunch, t = 250 and 280 min
Secondary outcome [14] 417511 0
Plasma GLP-1
Timepoint [14] 417511 0
Baseline, t = -45 and -15min
Post-ingestion of whey protein, t = 15 and 30 min
Post-ingestion of mixed meal test, t = 45, 60, 90, 120, 180, and 210 min
Post-ingestion of lunch, t = 250 and 280 min
Secondary outcome [15] 417512 0
Plasma glucagon
Timepoint [15] 417512 0
Baseline, t = -45 and -15min
Post-ingestion of whey protein, t = 15 and 30 min
Post-ingestion of mixed meal test, t = 45, 60, 90, 120, 180, and 210 min
Post-ingestion of lunch, t = 250 and 280 min

Eligibility
Key inclusion criteria
• Male and female
• Age between 18 and 60 years
• Body mass index (BMI) between 18-25 kg/m2
• Normal fasting plasma glucose (less than or equal to 5.5 mmol/L)
• Otherwise Healthy, according to self-report
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Fasting plasma glucose >5.6 mmol/L, or known Type 1 or type 2 diabetes mellitus
• Medications controlling glycaemia
• Current or history of significant disease including cardiovascular disease; pancreatic disease, or other digestive diseases including inflammatory bowel syndrome/disease, ulcerative colitis, Crohn's disease; cancer; plus associated medications including steroids and atypical antipsychotics
• Recent body weight loss/gain > 10 % within previous 3 months or taking part in an active diet program; or current medications for weight loss; or intending to alter physical activity during study period.
• Previous bariatric surgery
• Current illness (including gastrointestinal or eating disorders)
• Taking any medication which might impact metabolic rate during the last 3 months
• Smoker or vaper, current or in previous 6 months
• Recreational drug user, current or in previous 6 months
• Pregnant or breastfeeding women, current or in previous 6 months
• Blood donation within previous 3 months
• Dislike or unwilling to consume test products, or hypersensitivities or allergies to these foods
• Unwilling/unable to comply with study protocol
• Participation in other clinical intervention studies, current or in previous 6 months
• Low iron status
• Considered unsuitable to participate by the PI

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An a priori estimation of required sample size to provide a power of 0.95 (1- ß) is formed based on the data from previous study knowledge. Thus, this study will recruit 20 individuals to allow detection of any significant difference in postprandial mean plasma glucose (primary variable) of 0.5 mmol/L over 10 postprandial time points between three different test beverages (whey protein hydrolysate, whey protein isolate, and water control), with an estimated within participant variance (SD) of 0.5 mmol/L. This estimated sample size (n=15) has been increased to n=20 to allow for a 20% drop out rate.
Repeated measures ANOVA/linear mixed-models will be used to compare postprandial change in the outcome variable(s) following consumption of the test and control products. Statistical significance will be set at p = 0.05 for all analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/02/2023
Actual
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
30/04/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 25133 0
New Zealand
State/province [1] 25133 0
Auckland

Funding & Sponsors
Funding source category [1] 312624 0
Government body
Name [1] 312624 0
New Zealand Ministry of Business, Innovation and Enterprise (MBIE) (New Zealand National Science Challenge High Value Nutrition Programme)
Country [1] 312624 0
New Zealand
Primary sponsor type
University
Name
University of Auckland Research Office
Address
Level 10, Building 620
49 Symonds St
Auckland 1010
New Zealand
Country
New Zealand
Secondary sponsor category [1] 314253 0
None
Name [1] 314253 0
Address [1] 314253 0
Country [1] 314253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311943 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 311943 0
Ethics committee country [1] 311943 0
New Zealand
Date submitted for ethics approval [1] 311943 0
14/11/2022
Approval date [1] 311943 0
01/12/2022
Ethics approval number [1] 311943 0
2022 EXP 13859

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122922 0
A/Prof Jennifer Miles-Chan
Address 122922 0
University of Auckland
Human Nutrition Unit,
18 Carrik Place, Mt Eden, Auckland 1024
Country 122922 0
New Zealand
Phone 122922 0
+64 9 923 4322
Fax 122922 0
Email 122922 0
[email protected]
Contact person for public queries
Name 122923 0
Jia Jiet Lim
Address 122923 0
University of Auckland
Human Nutrition Unit,
18 Carrick Place, Mt Eden, Auckland 1024
Country 122923 0
New Zealand
Phone 122923 0
+64 9 630 1162
Fax 122923 0
Email 122923 0
[email protected]
Contact person for scientific queries
Name 122924 0
Jia Jiet Lim
Address 122924 0
University of Auckland
Human Nutrition Unit,
18 Carrick Place, Mt Eden, Auckland 1024
Country 122924 0
New Zealand
Phone 122924 0
+64 9 630 1162
Fax 122924 0
Email 122924 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only individual participant data underlying published results collected during the trial, after de-identification, may be shared.
When will data be available (start and end dates)?
Availability start immediately following publication, no end date determined.
Available to whom?
Case by case basis at the discretion of the primary sponsor
Available for what types of analyses?
Only to achieve aims in the approved proposal.
How or where can data be obtained?
Access is subject to approvals by the principal investigator ([email protected]), with a requirement to sign data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17989Informed consent form    384966-(Uploaded-10-01-2023-07-01-33)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.