Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001002976
Ethics application status
Approved
Date submitted
20/04/2020
Date registered
6/10/2020
Date last updated
4/11/2022
Date data sharing statement initially provided
6/10/2020
Date results information initially provided
21/06/2021
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
Acute study: stage 1
First visit
• Eligible participants will sign a consent form and complete a dietary questionnaire (24-hour food recall), medical history and ethnicity questionnaire. Participants will also be asked to complete questionnaire to assess their physical activity using the International Physical Activity Questionnaire (IPAQ) short.
• Participants will have their anthropometric measurements and blood pressure taken followed by a baseline venous blood sample (15 ml) for measurement of study outcomes
• Participants will be asked to consume the yoghurt plus breakfast on site. A venous blood sample (6 ml) will be taken at 30 min, 60 min, 120 min, 180 and 240 min post yoghurt consumption

Second visit
• After at least 7 days washout period, participants will be asked to consume the other yoghurt (in a crossover) plus breakfast on site. Venous blood samples (6ml) will be taken at baseline, 30 min, 60 min, 120 min, 180 and 240 min post yoghurt consumption

Chronic study: Stage 2
Stage 2 will only occur if the expected results from stage 1 are achieved. Participant from the stage 1 study will be invited to participate in stage 2. However, the study will also be advertised to the general public.

First visit
• Eligible participants will sign a consent form and complete a dietary questionnaire (24-hour food recall), medical history and ethnicity questionnaire. Participants will also be asked to complete questionnaire to assess their physical activity using the International Physical Activity Questionnaire (IPAQ) short.
• Participants will have their anthropometric measurements and blood pressure taken followed by a venous blood sample (15 ml) collected for measurement of study outcomes
• At the end of the visit, participants will be given 1- weeks’ worth of yoghurt to take home and begin consuming daily after a 1-week washout period. Another 1- weeks’ worth of yoghurt will be provided to the participants during week-2, to consume daily (for a total of 14 days of yoghurt consumption).

Second visit
- After 21 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.

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, 3 and 4 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, 3 and 4 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, 3 and 4 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 and 30 minutes, 1, 2, 3 and 4 hours post yogurt consumption

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
Sex
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
Completed
Date of first participant enrolment
Anticipated
30/10/2020
Actual
30/11/2020
Date of last participant enrolment
Anticipated
Actual
30/04/2021
Date of last data collection
Anticipated
31/12/2021
Actual
31/05/2021
Sample size
Target
22
Accrual to date
Final
16
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
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
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
09/10/2020
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
[email protected]
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
[email protected]
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
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Ahmed Nasef, N.; Thota, R.N.; Mutukumira, A.N.; Ru... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBioactive Yoghurt Containing Curcumin and Chlorogenic Acid Reduces Inflammation in Postmenopausal Women.2022https://dx.doi.org/10.3390/nu14214619
N.B. These documents automatically identified may not have been verified by the study sponsor.