Definition: Extended description of the protocol, including more technical information
(as compared to the Brief Summary), if desired. Do not include the entire protocol; do
not duplicate information recorded in other data elements, such as Eligibility Criteria
or outcome measures. For Patient Registries: Also describe the applicable registry
procedures and other quality factors (for example, third party certification, on-site
audit). In particular, summarize any procedures implemented as part of the patient
registry, including, but not limited to the following:
Quality assurance plan that addresses data validation and registry procedures,
including any plans for site monitoring and auditing.
Data checks to compare data entered into the registry against predefined rules for
range or consistency with other data fields in the registry.
Source data verification to assess the accuracy, completeness, or representativeness
of registry data by comparing the data to external data sources (for example,
medical records, paper or electronic case report forms, or interactive voice
response systems).
Data dictionary that contains detailed descriptions of each variable used by the
registry, including the source of the variable, coding information if used (for
example, World Health Organization Drug Dictionary, MedDRA), and normal ranges if
relevant.
Standard Operating Procedures to address registry operations and analysis
activities, such as patient recruitment, data collection, data management, data
analysis, reporting for adverse events, and change management.
Sample size assessment to specify the number of participants or participant years
necessary to demonstrate an effect.
Plan for missing data to address situations where variables are reported as missing,
unavailable, non-reported, uninterpretable, or considered missing because of data
inconsistency or out-of-range results.
Statistical analysis plan describing the analytical principles and statistical
techniques to be employed in order to address the primary and secondary objectives,
as specified in the study protocol or plan.
Randomised, double-blinded, placebo-controlled, parallel study in overweight and obese
adults.
Participants will be provided with an 8-week supply of product (60 sachets) at Visit 2
and instructed to consume one sachet per day for eight-weeks. Participants will be
recruited via an initial pre-screening questionnaire.
Visit 1 - Screening
Participants will receive oral and written information about the study and be
allowed to ask questions, sign the informed consent document, Inclusion and
exclusion criteria will be reviewed, Demographic, health, and lifestyle data will be
collected.
Participants will be provided with a stool collection kit and a urine collection kit
and instructions for collecting and storing.
Visit 2 - Day 1
- Participant's continued consent to study procedures will be confirmed.
Inclusion/exclusion criteria will be reviewed. Concomitant medication/supplements
will be recorded. Full anthropometrics taken. Participants will return their
collected stool samples and samples will be stored for further analysis. Fasting
blood samples will be collected for safety analysis and for blood
markers/metabolites.
Participants will be randomised into one of the two treatment groups as follows, but will
be blinded as to which group they are in:
Participants will be provided with a stool collection kit and a urine collection kit and
instructions for collecting and storing.
Visit 3 - Day 57
Participants will return to the study site at day 57, having completed the intervention
phase of the study. Participants will have fasted overnight for at least 10-hours. The
following procedures will be carried out: Participant's continued consent to study
procedures will be confirmed. Anthropometrics taken. Adverse events will be recorded.
Participants will return their collected stool sample and sample will be stored for
further analysis. Fasting blood samples will be collected for safety analysis and for
blood markers/metabolites. Participants will return any unused Study Product and
compliance will be assessed. Participants will collect 5-hour urine sample on-site.
Visit 4 - Day 84 (Follow-up Phase)
- Concomitant medication/supplements will be recorded. Anthropometrics taken. Adverse
events will be recorded. Participants will return their collected stool samples and
will be stored for
further analysis. A fasting blood sample will be collected. Participants will return with
the 24 h urine collected at home the day prior of their visit.
Participants have the right to withdraw from the study at any time for any reason,
without giving a reason and without penalty or loss of benefits they are entitled to.
Data processing & Management
Data required for the analysis will be acquired and transferred electronically to a
central database by means of an Electronic Data Capture system (the "EDC-tool"). The
EDC-tool will comprise an eCRF, designed specifically for the present study. High
security standards for the transfer and storage of study data are guaranteed using
technologies such as encrypted data transfer, firewalls, and periodic backup to protect
centrally stored data. The eCRF is based on the electronic data capture system developed
by Clindox, which is fully compliant with and a Gold Member of the Clinical Data
Interchange Standards Consortium. The eCRF will be hosted on a dedicated validated
stand-alone server placed in a double locked server room. According to the standards of
the data protection law, all data obtained in the course of the study will be treated
with discretion in order to guarantee the rights of the Participant's privacy.
Monitoring
The responsible monitor will contact and visit the clinical site regularly and will be
allowed, on request, to review the various records of the study (CRFs/eCRFs and other
pertinent data) provided that Participant confidentiality is maintained in accordance
with local requirements and as specified in the contract. The monitor will review the
study documents (e.g., CRFs) at regular intervals throughout the study, to verify the
adherence to the protocol and the legibility, completeness, consistency, and accuracy of
the data being entered on them. The monitor will have access to laboratory test reports
and other Participant records needed to verify the entries on the CRF/eCRF. This source
data verification may be carried out remotely.
Quality assurance and quality control
All Study Product used will be subjected to quality control. Quality assurance audits
will be performed by the Sponsor (or any health authority) during the course of the
clinical study or after its completion
Adverse Events (AE):
For purposes of this study all AEs reported will be unexpected. The causality assessment
of an AE to the investigational and/or study procedure(s) product will be rated as
Unrelated, Unlikely, Possible, Probable or definite using accepted criteria for clinical
trials. The severity of AEs will be recorded, including the start and stop dates for each
change in severity, and graded on a five-point-scale in accordance with the Common
Terminology Criteria for Adverse Events. The outcome of AEs will be followed up and
recorded. All Adverse Events (AEs) occurring during clinical studies will be recorded in
the eCRF. During the course of the study, complete reports of all AEs will be entered in
the Participants site source documents, and if applicable, on the appropriate study case
report forms (CRFs). A licensed clinician will be responsible for: identifying and
evaluating the severity (mild, moderate, or severe) and clinical importance of the AE,
taking appropriate medical action(s), and for notifying the Sponsor immediately of an SAE
as specified in the protocol and for notifying the Science Department for reporting to
the IRB/IEC. For any laboratory abnormality, the PI or Sub-Investigator will make a
judgement as to its clinical significance. The PI or Sub-Investigator will comply with
applicable regulatory requirement(s) related to the reporting of SAEs to the IRB/IEC.
The Monitor(s) will review completed CRF data and will compare CRF entries with
information recorded in the source documents. Any discrepancies or omissions in either
data source will be discussed with the site personnel who should make the appropriate
corrections to the documents.