Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530394
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Effects of Increased Greek Yogurt Consumption in Senior Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Increased Greek Yogurt Consumption on Circulating Markers of Bone Metabolism and Inflammation in Senior Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
This study aims to examine whether Greek yogurt GY consumption will lead to beneficial changes in bone metabolism and inflammation in senior adults male and female when combined with regular exercise senior fit classes GYEX and without exercise GYNE It is hypothesized that compared to a control group senior fit classes no GY NYEX an 8-week GY consumption intervention in senior adults with and without exercise will lead to positive effects on body composition and markers of bone metabolism and inflammation such that the anabolic and anti-inflammatory markers of these physiological processes will increase more than any training-induced catabolic and pro-inflammatory markers ie more than measures observed in the NYNE group
Detailed Description:
Participants
The proposed project will follow a randomized controlled parallel design over 8 weeks A total of 60 senior adults aged 55 years males and females from the Brock Senior Fit program and Niagara area All participants will provide written informed consent in order to be included in the study Potential participants will complete a standardized Get Active screening questionnaire of the Canadian Society for Exercise Physiology Participants will be excluded from the study if they are injured and unable to participate in classes have an allergy to dairy foodsdairy protein or have been diagnosed with lactose intolerance
Study Design and Procedures
Participants will be invited to participate in this 8-week study with senior fit participants being randomly assigned into the control NYEX or the intervention exercising GYEX group and non-senior fit citizens from the Niagara community will be assigned to the intervention non-exercising group GYNE
Control NYEX Group During the 8-weeks participants will be instructed to follow their typical habitual diet and exercise regimen
Intervention Exercising GYEX Group During the 8 weeks participants will be instructed to follow their typical habitual diet and exercise regimen Participants will be asked to consume 2 servingsday preferably morning and night of 175 grams of commercially available GY 0 fat flavoured 130 calories 17 grams protein 225 grams calcium eg OIKOS High Protein GY for a total of 8 weeks For their convenience the participants will be provided with appropriate scoops to measure out 175 grams of GY per serving of the larger 650-gram commercially available pre-packaged containers Although it is recommended to consume the two servings morning and night to increase ecological validity and strengthen the feasibility of the intervention the timing of the servings will be flexible to facilitate daily routines and lifestyles For the same reasons the participants will be able to choose the flavour of their GY
Intervention Non-Exercising GYNE Group During the 8-weeks participants will be instructed to follow their typical habitual diet Participants will be asked to consume 2 servingsday preferably morning and night of 175 grams of commercially available GY 0 fat flavoured 130 calories 17 grams protein 225 grams calcium eg OIKOS High Protein GY for a total of 8 weeks For their convenience the participants will be provided with appropriate scoops to measure out 175 grams of GY per serving of the larger 650-gram commercially available pre-packaged containers Although it is recommended to consume the two servings morning and night to increase ecological validity and strengthen the feasibility of the intervention the timing of the servings will be flexible to facilitate daily routines and lifestyles For the same reasons the participants will be able to choose the flavour of their GY
At weeks 0 and 8 the beginning and end of the study all participants will complete a series of nutrition and activity questionnaires and have their body composition measured and their fasted resting morning blood collected All participants will be instructed not to consume any food or liquids except water as needed 8 hours before the time of their blood draw not to exercise for 12 hours before the blood draw and not to make any changes to their normal routines These measurements will take place in the Applied Physiology Laboratory at Brock University by the same investigators
Measurements
The following measurements will be collected at the beginning week 0 and completion of the study week 8
Blood analysis A total of 10 microliters mL of blood will be collected from an antecubital vein by a certified phlebotomist or registered nurse using a standardized venipuncture technique All blood samples will be centrifuged for 10 minutes Serum and plasma will be aliquoted into pre-labelled Eppendorf tubes and stored at -80C until analysis The serum concentrations of markers and regulators of bone remodelling will be analyzed in duplicate using ELISA kits for osteocalcin amino-terminal propeptide of type I collagen P1NP and osteoprotegerin OPG and bone resorption C-telopeptides of type I collagen CTX sclerostin receptor activator of nuclear factor kappa-Β ligand RANKL and parathyroid hormone PTH The plasma concentrations of inflammatory cytokines including interleukin-6 IL6 interleukin-10 IL10 tumour necrosis factor-alpha TNFα insulin-like growth factor 1 IGF1 irisin and brain-derived neurotrophic factor BDNF will be measured in triplicate using commercially available ELLA kits Plasma analyses will be performed in-house at the Centre for Bone and Muscle Health at Brock University
Body Composition Body mass and body composition including lean body mass LBM fat mass FM and relative body fat percent BF will be measured using bioelectrical impedance analysis BIA InBody520 bioelectrical impedance analysis system Biospace Co Inc Los Angeles CA USA following standard procedures
Dietary and Physical Activity Assessment Participants energy intake and expenditure including dietary intake as well as macronutrient micronutrient vitamin and supplement intakes will be recorded at weeks 0 and 8 using a standardized Food Frequency and Activity Questionnaire FFAQ In addition participants nutrition knowledge will be assessed using the self-reported 97-item General and Sport-Specific Nutrition Knowledge Questionnaire GeSNK developed by Calella et al 2017 The GeSNK encompasses 64 items assessing general and sport-specific nutrition knowledge to explore knowledge regarding macro- and micronutrients in various food choices awareness of diet-health associations knowledge of fluid replacement supplement intake and food choices regarding sport recovery meals As mentioned above the GeSNK will be completed online along with the medical screening questions used to screen for inclusion criteria
Sample size calculation
To our knowledge no study has assessed the impact of dairy consumption on markers of bone metabolism and inflammation in male and female seniors Using GPower analysis for a repeated measures analysis of variance 3 intervention groups 2 timepoints sex as covariate we calculated that a total sample size of n 54 ie 18 per intervention group would be required to detect a medium effect of partial η2 006 with a power of 1-β 090 and a probability level of p 005 Thus the proposed total of 60 participants is more than adequate to detect significant effects and interactions while allowing for a 20 attrition rate
The proposed project will follow a randomized controlled parallel design over 8 weeks A total of 60 senior adults aged 55 years males and females from the Brock Senior Fit program and Niagara area All participants will provide written informed consent in order to be included in the study Potential participants will complete a standardized Get Active screening questionnaire of the Canadian Society for Exercise Physiology Participants will be excluded from the study if they are injured and unable to participate in classes have an allergy to dairy foodsdairy protein or have been diagnosed with lactose intolerance
Study Design and Procedures
Participants will be invited to participate in this 8-week study with senior fit participants being randomly assigned into the control NYEX or the intervention exercising GYEX group and non-senior fit citizens from the Niagara community will be assigned to the intervention non-exercising group GYNE
Control NYEX Group During the 8-weeks participants will be instructed to follow their typical habitual diet and exercise regimen
Intervention Exercising GYEX Group During the 8 weeks participants will be instructed to follow their typical habitual diet and exercise regimen Participants will be asked to consume 2 servingsday preferably morning and night of 175 grams of commercially available GY 0 fat flavoured 130 calories 17 grams protein 225 grams calcium eg OIKOS High Protein GY for a total of 8 weeks For their convenience the participants will be provided with appropriate scoops to measure out 175 grams of GY per serving of the larger 650-gram commercially available pre-packaged containers Although it is recommended to consume the two servings morning and night to increase ecological validity and strengthen the feasibility of the intervention the timing of the servings will be flexible to facilitate daily routines and lifestyles For the same reasons the participants will be able to choose the flavour of their GY
Intervention Non-Exercising GYNE Group During the 8-weeks participants will be instructed to follow their typical habitual diet Participants will be asked to consume 2 servingsday preferably morning and night of 175 grams of commercially available GY 0 fat flavoured 130 calories 17 grams protein 225 grams calcium eg OIKOS High Protein GY for a total of 8 weeks For their convenience the participants will be provided with appropriate scoops to measure out 175 grams of GY per serving of the larger 650-gram commercially available pre-packaged containers Although it is recommended to consume the two servings morning and night to increase ecological validity and strengthen the feasibility of the intervention the timing of the servings will be flexible to facilitate daily routines and lifestyles For the same reasons the participants will be able to choose the flavour of their GY
At weeks 0 and 8 the beginning and end of the study all participants will complete a series of nutrition and activity questionnaires and have their body composition measured and their fasted resting morning blood collected All participants will be instructed not to consume any food or liquids except water as needed 8 hours before the time of their blood draw not to exercise for 12 hours before the blood draw and not to make any changes to their normal routines These measurements will take place in the Applied Physiology Laboratory at Brock University by the same investigators
Measurements
The following measurements will be collected at the beginning week 0 and completion of the study week 8
Blood analysis A total of 10 microliters mL of blood will be collected from an antecubital vein by a certified phlebotomist or registered nurse using a standardized venipuncture technique All blood samples will be centrifuged for 10 minutes Serum and plasma will be aliquoted into pre-labelled Eppendorf tubes and stored at -80C until analysis The serum concentrations of markers and regulators of bone remodelling will be analyzed in duplicate using ELISA kits for osteocalcin amino-terminal propeptide of type I collagen P1NP and osteoprotegerin OPG and bone resorption C-telopeptides of type I collagen CTX sclerostin receptor activator of nuclear factor kappa-Β ligand RANKL and parathyroid hormone PTH The plasma concentrations of inflammatory cytokines including interleukin-6 IL6 interleukin-10 IL10 tumour necrosis factor-alpha TNFα insulin-like growth factor 1 IGF1 irisin and brain-derived neurotrophic factor BDNF will be measured in triplicate using commercially available ELLA kits Plasma analyses will be performed in-house at the Centre for Bone and Muscle Health at Brock University
Body Composition Body mass and body composition including lean body mass LBM fat mass FM and relative body fat percent BF will be measured using bioelectrical impedance analysis BIA InBody520 bioelectrical impedance analysis system Biospace Co Inc Los Angeles CA USA following standard procedures
Dietary and Physical Activity Assessment Participants energy intake and expenditure including dietary intake as well as macronutrient micronutrient vitamin and supplement intakes will be recorded at weeks 0 and 8 using a standardized Food Frequency and Activity Questionnaire FFAQ In addition participants nutrition knowledge will be assessed using the self-reported 97-item General and Sport-Specific Nutrition Knowledge Questionnaire GeSNK developed by Calella et al 2017 The GeSNK encompasses 64 items assessing general and sport-specific nutrition knowledge to explore knowledge regarding macro- and micronutrients in various food choices awareness of diet-health associations knowledge of fluid replacement supplement intake and food choices regarding sport recovery meals As mentioned above the GeSNK will be completed online along with the medical screening questions used to screen for inclusion criteria
Sample size calculation
To our knowledge no study has assessed the impact of dairy consumption on markers of bone metabolism and inflammation in male and female seniors Using GPower analysis for a repeated measures analysis of variance 3 intervention groups 2 timepoints sex as covariate we calculated that a total sample size of n 54 ie 18 per intervention group would be required to detect a medium effect of partial η2 006 with a power of 1-β 090 and a probability level of p 005 Thus the proposed total of 60 participants is more than adequate to detect significant effects and interactions while allowing for a 20 attrition rate
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