Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593769
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Glycemic and Appetite Effects of a Pre-meal Whey-Protein Microgel
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Glycemic and Appetite Effects of a Pre-meal Whey-Protein Microgel the GAP Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GAP
Brief Summary:
In this study the investigators want to assess the effects of a short-term twice daily pre-meal consumption of a liquid whey-protein microgel formulation when compared to placebo ie water on
post-prandial glucose
appetite This is an open-label study in 18 overweight or obese participants This study will be performed in one center the Clinical Innovation Laboratory CIL Nestlé Research Lausanne Participants will be screened and randomly assigned to 1 of 2 sequences of consumption Enrolled participants will then consume the test product or placebo pre-breakfast and pre-lunch for four days and then crossover to the other product over a period of 12 days
post-prandial glucose
appetite This is an open-label study in 18 overweight or obese participants This study will be performed in one center the Clinical Innovation Laboratory CIL Nestlé Research Lausanne Participants will be screened and randomly assigned to 1 of 2 sequences of consumption Enrolled participants will then consume the test product or placebo pre-breakfast and pre-lunch for four days and then crossover to the other product over a period of 12 days
Detailed Description:
This study aims to provide new insights and confirm a number of previous observations related to the role of whey-protein microgel in supporting glycemic regulation and supporting appetite regulation in people with overweight or obesity
- Primary objective The primary objective is to assess the effect of a pre-meal intake of whey-protein microgel WPM versus placebo on post-prandial glucose PPG response after a standardized breakfast meal in participants with BMI of 27 - 35 kgm2 aged between 45 and 70 years
Primary endpoint
The primary endpoint is the 2-hour iAUC postprandial glucose PPG excursion induced by a standardized breakfast with pre-breakfast -15 min WPM compared to placebo
- Secondary objectives The secondary exploratory objective is to compare the effect of pre-meal -15 min intake at breakfast and lunch of WPM versus placebo on appetite and further glycemic parameters in participants with BMI of 27 - 35 kgm2 aged between 45 and 70 years
Secondary endpoints
1 Hungerfullness visual analogue scale scores and composite appetite scores onwards from pre-meal consumption of WPM or placebo -15 min during breakfast and lunch on visit days
2 Amount of food consumed during ad libitum lunch meal on visit days
3 2-hour iAUC-15-120min of PPG excursion induced by an ad libitum lunch with pre-lunch -15 min WPM vs placebo
4 Mean 24h glucose from continuous glucose monitor CGM Mean of day 2 0800 AM to day 5 0800 AM with placebo vs Day 2-5 with WPM same time period as without WPM
5 Mean glucose from CGM considering only assumed breakfast and lunch time measures 0800 AM - 0400 PM on day 2 - 4 between WPM and placebo
6 Glucose stability from CGM mean 24h interquartile glucose range of day 2 0800 AM to day 5 0800 AM with placebo vs Day 2-5 with WPM same time period as without product WPM
7 Glucose stability from CGM considering only assumed breakfast and lunch time measures mean interquartile glucose range of day 2-4 0800 AM - 0400 PM with placebo vs Day 2-4 with WPM same time period as without product WPM
8 Effects on primary and secondary exploratory endpoints by subgroups defined by median BMI
The overall study implementation phase is expected to last for approximately 10 weeks Expected duration of recruitment and screening procedures up to 4 weeks For logistical reasons the participants will be divided in 2 groups with each groups study visits V1 to V4 lasting 3 weeks each The study is planned from Q2 to Q4 2024 This study will be conducted in compliance with the protocol the current version of the Declaration of Helsinki the ICH-GCP the HRA as well as other locally relevant legal and regulatory requirements
- Sample size calculations and randomization A total of 15 participants completers will be required to detect an effect size of 056 representing a reduction of 20 in incremental AUC over 2h following the standardized breakfast iAUC-15-120min between WPM and placebo within-subject correlation of 08 and a power of 90 at the 2-sided 5 significance level Assuming a roughly 20 drop-out rate 18 participants are planned for enrollment
Participants who meet the eligibility criteria will be randomized in 11 allocation ratio to one of the sequences ie intervention groups sequence 1 WPM in Day 2 - Day 5 period 1 and placebo in Day 9 - Day 12 period 2 or sequence 2 placebo in period 1 and WPM in period 2 Randomization will be carried out using Medidata Rave RTSM
- Statistical analysis Baseline characteristics anthropometric measurements and blood laboratory measurements will be summarized for all participants in the ITT set Descriptive statistics of the laboratory blood measurements at baseline will be used to characterize the participants in the study A complete set of descriptive statistics records mean standard deviation median Q1 and Q3 will be provided for all data collected in the study Data and results will be illustrated with figures line plots and boxplots
For the analysis of the primary endpoint the glucose iAUC-15-120min incremental area under the curve in the time interval -15 min-120 minutes will be extracted from the continuous glucose monitoring device at specific time points 15 minutes pre-breakfast beginning of breakfast and then every 15 minutes after beginning of breakfast for 2 hours on visit days V2 V3 and V4 respectively For the comparison between WPM and placebo a mixed linear model with response the glucose iAUC-15-120min will be proposed with fixed covariates baseline blood glucose levels treatment and period period 1 or period 2 Participant identifier will be used as random effect For this efficacy study the FAS dataset is the population of primary interest to conclude on the primary objective with support from the per protocol dataset As an exploratory model for the analysis of the primary endpoint the curves of the continuous glucose monitoring in the time interval 15 minutes pre-breakfast to 2 hours after the beginning of breakfast on days V2 V3 and V4 respectively will be the responses of a functional mixed linear model with the same covariate as the linear mixed model explained above baseline blood glucose levels treatment arm and period
For the HungerFullness VAS score calculation the iAUC will be estimated as the sum of the areas located above the baseline value
- Datasets to be analysed Intention-to-treat ITT analysis population all randomized participants Safety analysis set SAF analysis population safety data eg adverse events are analyzed in the SAF which consists of all participants in the ITT population with documentation of at least one administration of study product ie whey protein microgel or placebo
Full Analysis Set FAS analysis population the FAS dataset includes all participantsinfants from SAF participants that took at least one dose of study product or placebo without participants who failed to satisfy study entry eligibility criteria or had no post-randomization data
Per Protocol PP analysis population PP dataset consists of participantsinfants from the FAS without any departures from the protocol which are believed to impact the primary analysis
- Study Monitoring The monitoring will be performed by the Centre de recherche Clinique CRC at CHUV Lausanne Monitoring visits allow the sponsor representative to evaluate study progress verify accuracy and completeness of eCRFs resolve any inconsistencies in the study records and ensure that all protocol requirements applicable local laws ICH guidelines and investigator obligations are fulfilled The monitoring activities will be performed at agreed times during the study and after the study has been completed The extent schedule and nature of monitoring activities based on the objective and design of the study are defined in a study specific monitoring plan drafted by the Clinical Project Manager CPM from the sponsor side and agreed upon and signed by the representatives of the external monitor the sponsor CPM and the sponsor Clinical Data Manager The investigator will allow sponsor representatives to periodically review the eCRF and corresponding office hospital and laboratory records source documents of each study participant Case report forms must be completed by the Investigator on a regular basis and prior to each monitoring visit
Data sources Most of data will be entered from the source document into an electronic Case Report Forms eCRF - web database entitled RAVE solution of iMedidata For some questionnaires data will be entered directly by the participant in an ePRO Medidata as source data transmitted automatically into the eCRF Data should be entered in eCRF within 7 days after the participants visit At the end of the study the Principal Investigator must sign each eCRF electronically
Investigators site data site personnel will directly enter these data into the eCRF via manual data entry The exhaustive list of data collected at each visit will be described in the Data Listing document The Data Listing document is written by the Clinical Data Manager CDM and approved by the Clinical Team All the site source documents are listed in the Source Data Log available in the related investigator file
Participant reported outcome the following questionnairesdiaries will be considered as Source document and entered by participant in ePRO The ePRO is directly linked to the eCRF and these data are automatically captured in the eCRF
The HungerFullness VAS Questionnaire will be considered as a source document and entered by the participant at site on scheduled time points on paper Records will be measured and entered into the eCRF by the study site staff
The Product Intake Compliance Questionnaire ePRO notebook will be considered as a source document and entered by the participant at home on scheduled timepoints Records will be verified in the eCRF by the study site staff
The Adverse Events and Concomitant Medications Diary ePRO notebook will be considered as a source document and entered by the participant at home available at any time Records will be verified in the eCRF by the study site staff and additional information clarified
External clinical and laboratory data in addition to the data recorded in the eCRF the laboratory results will be entered into Labkey database to be transferred into Life Science Analytics Framework LSAF for analysis and storage
The CGM data will be extracted through a local software and collected at site during the study visits The raw data files will be reconciled by CDM and stored in LSAF for further data analysis To ensure traceability the files will be downloaded in CSV format and converted into PDF Once converted each PDF file will be entitled using the participant ID and the visit date dated and electronically signed by the investigator The files will be then archived in Investigator Site Files
- Data Validation The CDM will validate all data entered into the eCRF All computerized edit checks programmed to validate the data at least on primary data outcome are described in the Data Validation Plan document written by the CDM
Data discrepancies will trigger automatic queries directly displayed on the screen when data entered are saved Manual Data Reports will be produced by CDM for review by the team regularly If necessary manual queries will be sent to the Investigator for clarification All these discrepanciesqueries must be documented answered or confirmed by the site using Medidata Query tools
- Primary objective The primary objective is to assess the effect of a pre-meal intake of whey-protein microgel WPM versus placebo on post-prandial glucose PPG response after a standardized breakfast meal in participants with BMI of 27 - 35 kgm2 aged between 45 and 70 years
Primary endpoint
The primary endpoint is the 2-hour iAUC postprandial glucose PPG excursion induced by a standardized breakfast with pre-breakfast -15 min WPM compared to placebo
- Secondary objectives The secondary exploratory objective is to compare the effect of pre-meal -15 min intake at breakfast and lunch of WPM versus placebo on appetite and further glycemic parameters in participants with BMI of 27 - 35 kgm2 aged between 45 and 70 years
Secondary endpoints
1 Hungerfullness visual analogue scale scores and composite appetite scores onwards from pre-meal consumption of WPM or placebo -15 min during breakfast and lunch on visit days
2 Amount of food consumed during ad libitum lunch meal on visit days
3 2-hour iAUC-15-120min of PPG excursion induced by an ad libitum lunch with pre-lunch -15 min WPM vs placebo
4 Mean 24h glucose from continuous glucose monitor CGM Mean of day 2 0800 AM to day 5 0800 AM with placebo vs Day 2-5 with WPM same time period as without WPM
5 Mean glucose from CGM considering only assumed breakfast and lunch time measures 0800 AM - 0400 PM on day 2 - 4 between WPM and placebo
6 Glucose stability from CGM mean 24h interquartile glucose range of day 2 0800 AM to day 5 0800 AM with placebo vs Day 2-5 with WPM same time period as without product WPM
7 Glucose stability from CGM considering only assumed breakfast and lunch time measures mean interquartile glucose range of day 2-4 0800 AM - 0400 PM with placebo vs Day 2-4 with WPM same time period as without product WPM
8 Effects on primary and secondary exploratory endpoints by subgroups defined by median BMI
The overall study implementation phase is expected to last for approximately 10 weeks Expected duration of recruitment and screening procedures up to 4 weeks For logistical reasons the participants will be divided in 2 groups with each groups study visits V1 to V4 lasting 3 weeks each The study is planned from Q2 to Q4 2024 This study will be conducted in compliance with the protocol the current version of the Declaration of Helsinki the ICH-GCP the HRA as well as other locally relevant legal and regulatory requirements
- Sample size calculations and randomization A total of 15 participants completers will be required to detect an effect size of 056 representing a reduction of 20 in incremental AUC over 2h following the standardized breakfast iAUC-15-120min between WPM and placebo within-subject correlation of 08 and a power of 90 at the 2-sided 5 significance level Assuming a roughly 20 drop-out rate 18 participants are planned for enrollment
Participants who meet the eligibility criteria will be randomized in 11 allocation ratio to one of the sequences ie intervention groups sequence 1 WPM in Day 2 - Day 5 period 1 and placebo in Day 9 - Day 12 period 2 or sequence 2 placebo in period 1 and WPM in period 2 Randomization will be carried out using Medidata Rave RTSM
- Statistical analysis Baseline characteristics anthropometric measurements and blood laboratory measurements will be summarized for all participants in the ITT set Descriptive statistics of the laboratory blood measurements at baseline will be used to characterize the participants in the study A complete set of descriptive statistics records mean standard deviation median Q1 and Q3 will be provided for all data collected in the study Data and results will be illustrated with figures line plots and boxplots
For the analysis of the primary endpoint the glucose iAUC-15-120min incremental area under the curve in the time interval -15 min-120 minutes will be extracted from the continuous glucose monitoring device at specific time points 15 minutes pre-breakfast beginning of breakfast and then every 15 minutes after beginning of breakfast for 2 hours on visit days V2 V3 and V4 respectively For the comparison between WPM and placebo a mixed linear model with response the glucose iAUC-15-120min will be proposed with fixed covariates baseline blood glucose levels treatment and period period 1 or period 2 Participant identifier will be used as random effect For this efficacy study the FAS dataset is the population of primary interest to conclude on the primary objective with support from the per protocol dataset As an exploratory model for the analysis of the primary endpoint the curves of the continuous glucose monitoring in the time interval 15 minutes pre-breakfast to 2 hours after the beginning of breakfast on days V2 V3 and V4 respectively will be the responses of a functional mixed linear model with the same covariate as the linear mixed model explained above baseline blood glucose levels treatment arm and period
For the HungerFullness VAS score calculation the iAUC will be estimated as the sum of the areas located above the baseline value
- Datasets to be analysed Intention-to-treat ITT analysis population all randomized participants Safety analysis set SAF analysis population safety data eg adverse events are analyzed in the SAF which consists of all participants in the ITT population with documentation of at least one administration of study product ie whey protein microgel or placebo
Full Analysis Set FAS analysis population the FAS dataset includes all participantsinfants from SAF participants that took at least one dose of study product or placebo without participants who failed to satisfy study entry eligibility criteria or had no post-randomization data
Per Protocol PP analysis population PP dataset consists of participantsinfants from the FAS without any departures from the protocol which are believed to impact the primary analysis
- Study Monitoring The monitoring will be performed by the Centre de recherche Clinique CRC at CHUV Lausanne Monitoring visits allow the sponsor representative to evaluate study progress verify accuracy and completeness of eCRFs resolve any inconsistencies in the study records and ensure that all protocol requirements applicable local laws ICH guidelines and investigator obligations are fulfilled The monitoring activities will be performed at agreed times during the study and after the study has been completed The extent schedule and nature of monitoring activities based on the objective and design of the study are defined in a study specific monitoring plan drafted by the Clinical Project Manager CPM from the sponsor side and agreed upon and signed by the representatives of the external monitor the sponsor CPM and the sponsor Clinical Data Manager The investigator will allow sponsor representatives to periodically review the eCRF and corresponding office hospital and laboratory records source documents of each study participant Case report forms must be completed by the Investigator on a regular basis and prior to each monitoring visit
Data sources Most of data will be entered from the source document into an electronic Case Report Forms eCRF - web database entitled RAVE solution of iMedidata For some questionnaires data will be entered directly by the participant in an ePRO Medidata as source data transmitted automatically into the eCRF Data should be entered in eCRF within 7 days after the participants visit At the end of the study the Principal Investigator must sign each eCRF electronically
Investigators site data site personnel will directly enter these data into the eCRF via manual data entry The exhaustive list of data collected at each visit will be described in the Data Listing document The Data Listing document is written by the Clinical Data Manager CDM and approved by the Clinical Team All the site source documents are listed in the Source Data Log available in the related investigator file
Participant reported outcome the following questionnairesdiaries will be considered as Source document and entered by participant in ePRO The ePRO is directly linked to the eCRF and these data are automatically captured in the eCRF
The HungerFullness VAS Questionnaire will be considered as a source document and entered by the participant at site on scheduled time points on paper Records will be measured and entered into the eCRF by the study site staff
The Product Intake Compliance Questionnaire ePRO notebook will be considered as a source document and entered by the participant at home on scheduled timepoints Records will be verified in the eCRF by the study site staff
The Adverse Events and Concomitant Medications Diary ePRO notebook will be considered as a source document and entered by the participant at home available at any time Records will be verified in the eCRF by the study site staff and additional information clarified
External clinical and laboratory data in addition to the data recorded in the eCRF the laboratory results will be entered into Labkey database to be transferred into Life Science Analytics Framework LSAF for analysis and storage
The CGM data will be extracted through a local software and collected at site during the study visits The raw data files will be reconciled by CDM and stored in LSAF for further data analysis To ensure traceability the files will be downloaded in CSV format and converted into PDF Once converted each PDF file will be entitled using the participant ID and the visit date dated and electronically signed by the investigator The files will be then archived in Investigator Site Files
- Data Validation The CDM will validate all data entered into the eCRF All computerized edit checks programmed to validate the data at least on primary data outcome are described in the Data Validation Plan document written by the CDM
Data discrepancies will trigger automatic queries directly displayed on the screen when data entered are saved Manual Data Reports will be produced by CDM for review by the team regularly If necessary manual queries will be sent to the Investigator for clarification All these discrepanciesqueries must be documented answered or confirmed by the site using Medidata Query tools
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None