Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000051549
Ethics application status
Approved
Date submitted
20/10/2015
Date registered
22/01/2024
Date last updated
22/01/2024
Date data sharing statement initially provided
22/01/2024
Date results provided
22/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of culinary herbs and spices on body weight, body composition, blood lipids and blood pressure in humans.
Scientific title
The effect of culinary herbs and spices with high ACE-inhibitory properties compared to herbs and spices with low ACE-inhibitory properties on body weight, body composition, blood lipids and blood pressure in overweight and obese humans.
Secondary ID [1] 287498 0
Nil
Universal Trial Number (UTN)
U1111-1174-6163
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight
 296246 0
Obesity
 296247 0
Hypertension
 296248 0
Hyperlipidaemia 296249 0
Condition category
Condition code
Diet and Nutrition 296516 296516 0 0
Obesity
Cardiovascular 296517 296517 0 0
Hypertension
Alternative and Complementary Medicine 296519 296519 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Capsules containing culinary herbs and spices were provided to participants. One group received high ACE-inhibitory herb and spice capsules (containing powdered amla (Emblica officinalis), cinnamon (Cinnamomun verum), cloves (Syzygium aromaticum), and oregano (Origanum vulgare)). Each capsule contained 600 mg of the herb spice mix powder. The high ACE-inhibitory group were instructed to take one capsule with water at meal times, three times per day (equates 1,800 mg herb spice mix per day). The intervention was for a 6 month period. Capsule containers with any remaining capsules were returned upon completion of the trial, to check for adherence.
Intervention code [1] 292882 0
Lifestyle
Comparator / control treatment
A herb and spice capsule containing low ACE-inhibitory herbs and spices was used as the comparator. This group received low ACE-inhibitory herb and spice capsules (containing powdered black pepper (Piper nigrum L.), red chilli (Capsicum frutescens L.), ginger (Zingiber officinale Roscoe), and turmeric (Curcuma longa L.). Each capsule contained 600 mg of the herb spice mix powder. The low ACE-inhibitory group were also instructed to take one capsule with water at meal times, three times per day (equates 1,800 mg herb spice mix per day). The intervention was for a 6 month period. Capsule containers with any remaining capsules were returned upon completion of the trial, to check for adherence.
Control group
Active

Outcomes
Primary outcome [1] 296141 0
Body weight assessed by digital scales
Timepoint [1] 296141 0
Baseline, 3 months, 6 months post-intervention commencement
Primary outcome [2] 336962 0
Blood pressure assessed by wrist cuff blood pressure monitor
Timepoint [2] 336962 0
Baseline, 3 months, 6 months post-intervention commencement
Secondary outcome [1] 317596 0
Body composition assessed by DEXA scan
Timepoint [1] 317596 0
Baseline, 3 months and 6 months post-intervention commencement
Secondary outcome [2] 430254 0
Blood lipids assessed by blood chemistry analyser
Timepoint [2] 430254 0
Baseline, 3 months and 6 months post-intervention commencement

Eligibility
Key inclusion criteria
Participants were checked against eligibility criteria before inclusion in the study. Inclusion criteria included: a good understanding of English, aged between 18 and 65 years, a BMI greater than 25.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included: pregnant women and people taking prescription medications. There was no upper BMI limit. Only data from participants who completed the 6 month intervention study was analysed.

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)
Subjects were checked against inclusion and exclusion criteria prior to enrolment for the study. Participants were consecutively assigned (1:1) to either the HighACEI or LowACEI herbs or spices. The study was double-blinded as to which treatment (either High-ACEi or Low-ACEi) was given to each treatment group, however, the allocation to group "blue" or group "red" was not concealed from the researchers. Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was done by allocating the first participant assessed into the HighACEI treatment group, and the following participant into the LowACEI treatment group, and so on.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Results for treatment groups were analysed by 2-way repeated measures analysis of variance (ANOVA), with herb and spice treatment and time as factors. The software package used was SPSS Inc. software (Version 14.0). Level of significance was chosen as 5%. Recruitment was time based, due to the nature of research project, and ran from January 2011 and ceased in June 2011.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/01/2011
Date of last participant enrolment
Anticipated
Actual
30/06/2011
Date of last data collection
Anticipated
Actual
6/09/2011
Sample size
Target
100
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 10583 0
3083 - La Trobe University
Recruitment postcode(s) [2] 10584 0
3088 - Greensborough
Recruitment postcode(s) [3] 10585 0
3072 - Preston
Recruitment postcode(s) [4] 10586 0
3073 - Reservoir
Recruitment postcode(s) [5] 10587 0
3087 - Watsonia
Recruitment postcode(s) [6] 10588 0
3084 - Heidelberg
Recruitment postcode(s) [7] 10589 0
3757 - Whittlesea

Funding & Sponsors
Funding source category [1] 292072 0
University
Name [1] 292072 0
LaTrobe University Post graduate funds
Country [1] 292072 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
1 Kingsbury Drive, Bundoora, Victoria 3086
Country
Australia
Secondary sponsor category [1] 317562 0
None
Name [1] 317562 0
Address [1] 317562 0
Country [1] 317562 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293556 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 293556 0
Ethics committee country [1] 293556 0
Australia
Date submitted for ethics approval [1] 293556 0
04/08/2010
Approval date [1] 293556 0
04/11/2010
Ethics approval number [1] 293556 0
10-061

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

Contacts
Principal investigator
Name 60438 0
Dr Jessica Radcliffe
Address 60438 0
La Trobe University, 1 Kingsbury Drive, Bundoora, Victoria 3086
Country 60438 0
Australia
Phone 60438 0
+61 3 9479 1504
Fax 60438 0
Email 60438 0
[email protected]
Contact person for public queries
Name 60439 0
Markandeya Jois
Address 60439 0
La Trobe University, 1 Kingsbury Drive, Bundoora, Victoria 3086
Country 60439 0
Australia
Phone 60439 0
+61 3 9479 2172
Fax 60439 0
Email 60439 0
[email protected]
Contact person for scientific queries
Name 60440 0
Markandeya Jois
Address 60440 0
La Trobe University, 1 Kingsbury Drive, Bundoora, VIC 3086
Country 60440 0
Australia
Phone 60440 0
+61 3 9479 2172
Fax 60440 0
Email 60440 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
This research was conducted in 2011 and is being registered retrospectively.


What supporting documents are/will be available?

No Supporting Document Provided



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.