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Trial registered on ANZCTR


Registration number
ACTRN12620001002976p
Ethics application status
Submitted, not yet approved
Date submitted
20/04/2020
Date registered
6/10/2020
Date last updated
6/10/2020
Date data sharing statement initially provided
6/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a bio-active yogurt in postmenopausal women
Scientific title
Effects of a yogurt enriched with dietary bio-active compounds on inflammatory markers in post-menopausal women
Secondary ID [1] 301048 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammation 317099 0
menopause 317100 0
Condition category
Condition code
Diet and Nutrition 315265 315265 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 316849 316849 0 0
Menstruation and menopause
Inflammatory and Immune System 316850 316850 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomized, cross-over design, double blinded, placebo controlled study

First visit:
• Participants will sign a consent form and complete a medical history, physical activity (iPAQ) & dietary questionnaires (24-hour food recall).
• Participants will have their anthropometric measurements and blood pressure taken, followed by a venous blood sample (15 ml) for measurement of study outcomes.
• Participants will be provided with the yogurt necessary for two weeks (150g yoghurt for consumption per day for 14 days) and a log sheet to record the time and day the yogurt was consume

Second visit:
• After 14 days, participants will be asked to complete another physical activity & dietary questionnaire
• Participants will have their anthropometric measurements and blood pressure taken, followed by a venous blood sample (15 mL) for study outcome measurements after an overnight fast
• Participants will be asked to consume the yoghurt plus breakfast on site. Venous blood samples (6ml) will be taken at 30 min, 60 min, 120 min and 180 min post yoghurt consumption.

Visit 1 and 2 will be repeated in a crossover after a wash-out period of minimum 1-week

Arm 1 is a coconut yoghurt containing turmeric and coffee extract. Arm 2 will be control yogurt. All study food will be prepared/developed a food grade accredited facility.
Intervention code [1] 317353 0
Lifestyle
Comparator / control treatment
Coconut yogurt containing no turmeric/coffee extract but matched for color
Control group
Placebo

Outcomes
Primary outcome [1] 323530 0
Plasma Tumor Necrosis Factor (TNF)– a) using ELISA
Timepoint [1] 323530 0
Visit 1 (both arms): Baseline and 14 days post yogurt consumption
Visit 2 (both arms): Baseline and 30 minutes, 1, 2 and 3 hours post yogurt consumption
Secondary outcome [1] 386362 0
Plasma IL6 (using ELISA)
Timepoint [1] 386362 0
Visit 1 (both arms): Baseline and 14 days post yogurt consumption
Visit 2 (both arms): Baseline and 30 minutes, 1, 2 and 3 hours post yogurt consumption
Secondary outcome [2] 386363 0
Plasma glucose (blood test)
Timepoint [2] 386363 0
Visit 1 (both arms): Baseline and 14 days post yogurt consumption
Visit 2 (both arms): Baseline and 30 minutes, 1, 2 and 3 hours post yogurt consumption
Secondary outcome [3] 386364 0
Plasma insulin (blood test)
Timepoint [3] 386364 0
Visit 1 (both arms): Baseline and 14 days post yogurt consumption
Visit 2 (both arms): Baseline and 30 minutes, 1, 2 and 3 hours post yogurt consumption
Secondary outcome [4] 386365 0
Plasma Triglycerides (blood test)
Timepoint [4] 386365 0
Visit 1 (both arms): Baseline and 14 days post yogurt consumption
Visit 2 (both arms): Baseline and 30 minutes, 1, 2 and 3 hours post yogurt consumption
Secondary outcome [5] 386366 0
Blood cholesterol (blood test) composite of fasting cholesterol, LDL-C and HDL-C
Timepoint [5] 386366 0
Visit 1 (both arms): Baseline and 14 days post yogurt consumption
Visit 2 (both arms): Baseline

Eligibility
Key inclusion criteria
• Women who have been menopausal for at least a year (defined as more than 12 months of consecutive amenorrhea)
• Aged between 45 and 65
• BMI between 25-40Kg/m2
Minimum age
45 Years
Maximum age
65 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Cigarette smokers
• Are on hormone replacement therapy
• Dairy intolerant
• Suffering from inflammatory illnesses including cancer, HIV/Aids or inflammatory bowel disease
• Recently donated blood or have fear of needles
• Are dieting or have any eating disorders and have lost more than 20 Kg weight in the last 6 months
• Have dislike, intolerance or allergy to yoghurt, coconut, coffee or curry
• Have a history of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or
atherosclerosis
• Have a history of cancer, diabetes, hypertension, high cholesterol
• Have a history of gastrointestinal disorder or liver disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22499 0
New Zealand
State/province [1] 22499 0

Funding & Sponsors
Funding source category [1] 305490 0
Other Collaborative groups
Name [1] 305490 0
Riddet CoRE
Address [1] 305490 0
Riddet Institute Massey University Tennent drive Palmerston North New Zealand 4442
Country [1] 305490 0
New Zealand
Primary sponsor type
University
Name
Riddet Institute
Address
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
4442
Country
New Zealand
Secondary sponsor category [1] 305888 0
None
Name [1] 305888 0
none
Address [1] 305888 0
NA
Country [1] 305888 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305803 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 305803 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 305803 0
New Zealand
Date submitted for ethics approval [1] 305803 0
01/05/2020
Approval date [1] 305803 0
Ethics approval number [1] 305803 0

Summary
Brief summary
We have previously developed a coconut yogurt enriched with turmeric and coffee bean extracts known for their benefits in metabolic disorders and chronic inflammatory diseases.

In the proposed study we aim to assess the developed yoghurt for its anti-inflammatory and metabolic effects in post-menopausal women after consuming the yogurt for 2 weeks. Postmenopause is associated with higher dyslipidemia, inflammation, and unbalanced oxidative status when compared to non-menopausal women. The higher inflammatory, oxidative and metabolic status in post-menopausal women increase their risk of metabolic disorders such as cardiovascular disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101650 0
Dr Noha Nasef
Address 101650 0
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
4442
Country 101650 0
New Zealand
Phone 101650 0
+64 69519421
Fax 101650 0
Email 101650 0
n.nasef@massey.ac.nz
Contact person for public queries
Name 101651 0
Dr Noha Nasef
Address 101651 0
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
4442
Country 101651 0
New Zealand
Phone 101651 0
+64 69519421
Fax 101651 0
Email 101651 0
n.nasef@massey.ac.nz
Contact person for scientific queries
Name 101652 0
Dr Noha Nasef
Address 101652 0
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
4442
Country 101652 0
New Zealand
Phone 101652 0
+64 69519421
Fax 101652 0
Email 101652 0
n.nasef@massey.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results