Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05882149
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2023-05-19
Brief Title:
Single Strain Probiotic
Sponsor:
Rosa Sola
Organization:
University Rovira i Virgili
Study Overview
Official Title:
Randomized Double-blind Parallel Placebo-controlled Study to Evaluate the Efficacy of Single Strain Probiotic Delivered in a Chewing Gum on the Reduction of Anthropometric Adiposity Biomarkers and the Improvement of Glucose Homeostasis in Abdominally Obese Individuals
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHOICE
Brief Summary:
Probiotics have been recognized as functional foods with beneficial effects against obesity and cardiometabolic diseases such as dyslipidemia type 2 diabetes and the reduction of visceral fat mass body weight and waist circumference
In previous studies it was shown that capsulepowder probiotic or postbiotic supplementation containing a single strain probiotic could reduce anthropometric parameters including the visceral fat area and contribute to type 2 diabetes management in subjects with abdominal obesity Similar findings were found when this single strain probiotic was delivered through enriched seafood sticks Results showed that enriched seafood sticks significantly reduced insulin concentrations and HOMA-IR pulse pressure waist circumference body weight and triglycerides
These findings suggest that this specific single strain probiotic as a probiotic or postbiotic could be a complementary strategy in the management of cardiometabolic disease risk factors
Probiotics have mostly been studied incorporated in dairy food matrix Other food matrices such as chewing gum have scarcely been exploited by the food industry Chewing gum as a novel vehicle for probiotics presents the ability to release active ingredients into the oral cavity with a steady and rapid action Furthermore it has a high acceptance amongst adults and children and present few side effects
No previous randomized controlled trials have examined the effect of a probiotic chewing gum on anthropometric adiposity biomarkers and glucose homeostasis in abdominally obese individuals
The main objective of the present study is to evaluate the efficacy of single strain probiotic in the reduction of waist circumference in abdominally obese individuals
The specific objectives
To evaluate the efficacy of single strain probiotic in the improvement of other anthropometric biomarkers waist-hip-ratio body weight BMI total fat mass visceral fat index free fat mass lean body mass conicity index visceral adipose tissue and subcutaneous fat
To evaluate the efficacy of single strain probiotic in the management of glucose homeostasis
To evaluate the efficacy of single strain probiotic in the management of serum lipid levels
To evaluate the efficacy of single strain probiotic in the reduction of blood pressure and pulse pressure
To asses Quality of life after single strain probiotic supplementation
To identify changes in caloric intake and subjective satiety after single strain probiotic supplementation
To identify changes in gastrointestinal health after single strain probiotic supplementation
To identify changes in the oral microbiome after single strain probiotic supplementation
To identify changes in the gastrointestinal microbiome after single strain probiotic supplementation
In previous studies it was shown that capsulepowder probiotic or postbiotic supplementation containing a single strain probiotic could reduce anthropometric parameters including the visceral fat area and contribute to type 2 diabetes management in subjects with abdominal obesity Similar findings were found when this single strain probiotic was delivered through enriched seafood sticks Results showed that enriched seafood sticks significantly reduced insulin concentrations and HOMA-IR pulse pressure waist circumference body weight and triglycerides
These findings suggest that this specific single strain probiotic as a probiotic or postbiotic could be a complementary strategy in the management of cardiometabolic disease risk factors
Probiotics have mostly been studied incorporated in dairy food matrix Other food matrices such as chewing gum have scarcely been exploited by the food industry Chewing gum as a novel vehicle for probiotics presents the ability to release active ingredients into the oral cavity with a steady and rapid action Furthermore it has a high acceptance amongst adults and children and present few side effects
No previous randomized controlled trials have examined the effect of a probiotic chewing gum on anthropometric adiposity biomarkers and glucose homeostasis in abdominally obese individuals
The main objective of the present study is to evaluate the efficacy of single strain probiotic in the reduction of waist circumference in abdominally obese individuals
The specific objectives
To evaluate the efficacy of single strain probiotic in the improvement of other anthropometric biomarkers waist-hip-ratio body weight BMI total fat mass visceral fat index free fat mass lean body mass conicity index visceral adipose tissue and subcutaneous fat
To evaluate the efficacy of single strain probiotic in the management of glucose homeostasis
To evaluate the efficacy of single strain probiotic in the management of serum lipid levels
To evaluate the efficacy of single strain probiotic in the reduction of blood pressure and pulse pressure
To asses Quality of life after single strain probiotic supplementation
To identify changes in caloric intake and subjective satiety after single strain probiotic supplementation
To identify changes in gastrointestinal health after single strain probiotic supplementation
To identify changes in the oral microbiome after single strain probiotic supplementation
To identify changes in the gastrointestinal microbiome after single strain probiotic supplementation
Detailed Description:
A total of 180 adult volunteers will be included in the intervention 90 in each arm of the intervention
During the CHOICE study there will be 6 visits in total Of these visits 3 will be face-to-face and 3 by telephone The study visits will be the following screening visit V0 face-to-face to check inclusionexclusion criteria and in case of satisfying the inclusion criteria basal visit V1 face-to- face visits during the intervention V2 V3 and V4 via telephone final study visit V5 face-to-face
In visits V0 V1 and V5 volunteers must present themselves in fasting conditions of 8 hours to obtain blood samples In visits V1 and V5 volunteers must bring saliva and faeces samples
In order to measure the changes in visceral adipose tissue up to five days prior to the visit V1 and approximately up to 3 days prior after the V5 volunteers must have a Nuclear Magnetic Resonance NMR for measuring visceral fat
CHOICE Study
Visit 0 V0 week -1 Recruitment and selection
Information to the volunteer and signature of the informed consent
Revision of the inclusionexclusion criteria
Elaboration of study clinical history
Vital signs blood pressureresting heart rate
Checking the concomitant medication
Anthropometry waist circumference hip body weight and composition height
Blood sample extraction
Delivery of the 3-day dietary record and the material for feaces and saliva sample recollection for V1
Schedule the first visit and instructions fasting
Visit 1 V1 week 0 Basal visit
NMR 5 days V1
Revision of study clinical history
Vital signs blood pressureresting heart rate
Checking the concomitant medication
Anthropometry waist circumference hip body weight and composition
Blood sample extraction
Abdominal fat Ultrasound
Checking the 3-day dietary record
Checking the Three Factor Eating Questionnaire TFEQ
Checking the Bing Eating Scale BES
Checking the satiety scale VAS and gastrointestinal health information
Collection of feaces samples
Collection of saliva samples
Delivery of the 3-day dietary record and the material for saliva and feaces sample for V5
Schedule the next telephone visit and also the final visit and instructions fasting
Visit 2 V2 week 3 Follow-up during the intervention
Checking the concomitant medication
Record adverse effects
Checking adherence to product consumption treatment compliance
Checking the satiety scale
Checking the gastrointestinal health
Schedule the next visit and instructions
Visit 3 V3 week 6 Follow-up during the intervention
Checking the concomitant medication
Record adverse effects
Checking adherence to product consumption treatment compliance
Checking the satiety scale
Checking the gastrointestinal health
Schedule the next visit and instructions
Visit 4 V4 week 9 Follow-up during the intervention
Checking the concomitant medication
Record adverse effects
Checking adherence to product consumption treatment compliance
Checking the satiety scale
Checking the gastrointestinal health
Schedule the next visit and instructions fasting
Visit 5 V2 week 12 Final visit
NMR 3 days before V5
Revision of study clinical history
Vital signs blood pressureresting heart rate
Anthropometry waist circumference hip body weight and composition
Checking the concomitant medication
Blood sample extraction
Abdominal fat Ultrasound
Checking the 3-day dietary record
Checking the TFEQ
Checking the BES
Record of adverse effects
Checking the treatment compliance
Checking the satiety scale VAS
Collection of feaces samples
Collection of saliva samples
During the CHOICE study there will be 6 visits in total Of these visits 3 will be face-to-face and 3 by telephone The study visits will be the following screening visit V0 face-to-face to check inclusionexclusion criteria and in case of satisfying the inclusion criteria basal visit V1 face-to- face visits during the intervention V2 V3 and V4 via telephone final study visit V5 face-to-face
In visits V0 V1 and V5 volunteers must present themselves in fasting conditions of 8 hours to obtain blood samples In visits V1 and V5 volunteers must bring saliva and faeces samples
In order to measure the changes in visceral adipose tissue up to five days prior to the visit V1 and approximately up to 3 days prior after the V5 volunteers must have a Nuclear Magnetic Resonance NMR for measuring visceral fat
CHOICE Study
Visit 0 V0 week -1 Recruitment and selection
Information to the volunteer and signature of the informed consent
Revision of the inclusionexclusion criteria
Elaboration of study clinical history
Vital signs blood pressureresting heart rate
Checking the concomitant medication
Anthropometry waist circumference hip body weight and composition height
Blood sample extraction
Delivery of the 3-day dietary record and the material for feaces and saliva sample recollection for V1
Schedule the first visit and instructions fasting
Visit 1 V1 week 0 Basal visit
NMR 5 days V1
Revision of study clinical history
Vital signs blood pressureresting heart rate
Checking the concomitant medication
Anthropometry waist circumference hip body weight and composition
Blood sample extraction
Abdominal fat Ultrasound
Checking the 3-day dietary record
Checking the Three Factor Eating Questionnaire TFEQ
Checking the Bing Eating Scale BES
Checking the satiety scale VAS and gastrointestinal health information
Collection of feaces samples
Collection of saliva samples
Delivery of the 3-day dietary record and the material for saliva and feaces sample for V5
Schedule the next telephone visit and also the final visit and instructions fasting
Visit 2 V2 week 3 Follow-up during the intervention
Checking the concomitant medication
Record adverse effects
Checking adherence to product consumption treatment compliance
Checking the satiety scale
Checking the gastrointestinal health
Schedule the next visit and instructions
Visit 3 V3 week 6 Follow-up during the intervention
Checking the concomitant medication
Record adverse effects
Checking adherence to product consumption treatment compliance
Checking the satiety scale
Checking the gastrointestinal health
Schedule the next visit and instructions
Visit 4 V4 week 9 Follow-up during the intervention
Checking the concomitant medication
Record adverse effects
Checking adherence to product consumption treatment compliance
Checking the satiety scale
Checking the gastrointestinal health
Schedule the next visit and instructions fasting
Visit 5 V2 week 12 Final visit
NMR 3 days before V5
Revision of study clinical history
Vital signs blood pressureresting heart rate
Anthropometry waist circumference hip body weight and composition
Checking the concomitant medication
Blood sample extraction
Abdominal fat Ultrasound
Checking the 3-day dietary record
Checking the TFEQ
Checking the BES
Record of adverse effects
Checking the treatment compliance
Checking the satiety scale VAS
Collection of feaces samples
Collection of saliva samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None