Ignite Creation Date:
2024-05-06 @ 8:53 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02849392
Status:
COMPLETED
Last Update Posted:
2016-08-02
First Post:
2016-07-25
Brief Title:
Effects of Pistachio Consumption on Body Composition and Blood and Bone Indicators
Sponsor:
California State Polytechnic University Pomona
Organization:
California State Polytechnic University Pomona
Study Overview
Official Title:
Effects of Pistachio Consumption on Body Composition Blood Lipids Bone Density Satiety Inflammatory Markers and Erythrocyte Membrane Incorporation of Fatty Acids The Cal Polys Pistachio Study
Status:
COMPLETED
Status Verified Date:
2016-07
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:
CPsPistachio
Brief Summary:
Research investigating beneficial effects of regular pistachio feedings on body composition BC and blood lipids are limited and there are no studies that have investigated the effects of feeding pistachios on bone density or membrane incorporation of fats The purpose of this study is to examine the effects of pistachio consumption on body composition bone density markers of bone turnover erythrocyte membrane incorporation of fatty acids lipid status inflammatory markers dietary qualitymicronutrients and satiety using a cross-over study with two 12-week treatment periods pistachio added 20 percent of kcals and a no-pistachio control diet separated by 15-week washout period The investigators will recruit 30 female students from Cal Poly San Luis Obispo CP-SLO and female 30 students from Cal Poly Pomona CP-P facilitating a collaborative project and using the expertise of both Dr Laura Hall CP-SLO and Dr Bonny Burns-Whitmore CP-P The investigators hope to show the health benefits of pistachios as part of an overall healthy lifestyle
Detailed Description:
Primary Research Objectives
1 To examine the effects of a diet rich in pistachios on body composition
2 Examine incorporation of healthy fats into red blood cell RBC membranes
3 Determine changes in blood lipids inflammatory markers and markers of bone turnover with pistachio consumption
4 Assess diet qualitymicronutrient quality and satiety with pistachio consumption
Methods Investigators will employ a crossover design with two 12-week treatment periods pistachio added and a no-pistachio control diet separated by 15-week washout period with 30 healthy students at each campus
Subjects Female students enrolled at CP-SLO and CP-P will be invited to participate in the study The first 30 qualified females will be enrolled in the study at each site A screening questionnaire will determine eligibility The interview will take 5 minutes This sample size provides more than adequate power 80 to detect individual changes
Recruitment Female students enrolled at CP-SLO and CP-P will be invited to participate in the study Potential subjects will be notified by flyers emails adds on marquees and peer recruitment in summer school classes The information on the flyer and emails will be approved by the Institutional Review Boards and contain information regarding inclusionexclusion criteria length of study and the risks and benefits Participants will be asked to contact either Dr Laura Hall CP-SLO or Dr Bonny Burns-Whitmore CP-P and then potential participants will be asked to fill out a screening questionnaire to determine eligibility
Study Design Methods We will employ a randomized crossover design with two 12-week treatment periods pistachio added 20 of kcals and a no-pistachio control diet separated by 15-week washout period with 30 healthy female students at each campus The first treatment period will be in Fall 2012 and the second treatment period will be in Spring 2013
Randomization to treatment pistachios or habitual control diet and 24-hour recalls Randomization will be done utilizing a wwwrandomizationcom list of random appointments to either the treatment group first or the control group first
Materials and Procedures
Study visits Participants will come to the CP-SLO n30 or CP-P n30 site once a week during Fall quarter for 12 weeks and again during Spring quarter for 12 weeks to pick up their pre-measured pistachios for a total of 24 total study visits At the initial visit half the participants will be given pistachios to include in their diet as snacks or in meals 20 percent of kcals intervention group while half will continue their normal diets control group During Spring the other half of the participants will switch and consume the pistachios while the first half will not Diet counseling will also be given at these visits and compliance to study protocols will be evaluated by counting the number of pistachio packages and looking at the participants Unusual Diet Diary At baseline and end of each treatment period participants will have their height weight waist circumference hip circumference body composition measured and blood drawn at both sites At CP-SLO they will also have their bone density measured DXA At the CP-P site they will have a fatty acid analysis performed to examine monounsaturated fatty acid incorporation into red blood cells RBCs
CalculationDistribution of Pistachios and InitialWeekly Study Visits During the lead-in period participants will meet initially and will be trained on keeping their food records by a Registered Dietitian RD During this week they will each keep a 3-day food record and turn it in immediately The researchers will calculate how many pistachios each participant needs based off of the initial 3-day food record This amount will be substituted as 20 percent of their usual caloric need and it will be pre-measured into daily individually-wrapped servings The researches will meet with the participants weekly to give them a weeks supply of their pre-measured packet of pistachios one for each day They will be asked to bring in their used wrappers to the weekly counseling meetings At the weekly counseling meetings participants will be shown how to incorporate the pistachios into their diet either as snacks or in recipes in an isocaloric diet to check the participants unusual diet diary and food records for accuracy to review the MyPlate guidelines and to check the empty pistachio wrappers for compliance Participants will also get emailtext reminders about meetings and reminder instructions on how to prepare for study visits
Data Collected at both sites during Fall 2012 wk 1 and wk 12 Spring 2013 wk 1 and wk 12
Anthropometric Measurements Body weight will be measured using a calibrated scale and recorded to the nearest 01 kg Height will be measured using a stadiometer and recorded to the nearest 01 cm Body mass index BMI will be calculated as weight kg divided by height m squared Waist circumference will be measured using a flexible measuring tape between the middle of the bottom rib and iliac crest top of the hip bone and recorded to the nearest 01 cm Hip circumference will be measured using a flexible measuring tape around the largest part of the hips ie buttocks and recorded to the nearest 01 cm Measurements will be taken twice and averaged We will also calculate their waist-to-hip ratio Protocols will be based on NHANES III standardized procedures and student volunteers will be thoroughly trained on these protocols see link-NHANES Blood Pressure Blood pressure will be taken using an automatic blood pressure monitor Protocol will be based on Mayo Clinic standardized procedures and student volunteers will be thoroughly trained on these protocols see link-Mayo Clinic
Body Composition Measurement Body fat percentage will be assessed by bioelectrical impedance analysis using the Tanita Body Composition Analyzer Scale model TBF-310 from Tanita Corporation Tokyo Japan It will also be used to measure weight body mass index BMI percent body fat impedance fat mass TBF fat free mass FFM total body mass TBM and total body water TBW The participants will need to fast for 12 hours before their study visit ie no caffeine in the morning but 15 cups of water prior to the visit will be encouraged
Food RecordsUnusual Diet Diary ie Dietary Adherence Compliance Adherence and compliance to the assigned diets will be assessed using an Unusual Diet Diary developed at CP-P which is filled out by the participant when unusual quantities of foods or accidental pistachio consumption occurs medical treatment is required a suspected allergic reactionside effect occurs or pharmaceuticals are consumed If a participant experiences an allergic reaction to pistachios they will have been told to call 911 and after contacting the researchers they will be removed from the study to limit further risk Food records will be administered during each treatment to obtain information regarding the subjects diet and determine if the subject is adhering to treatment protocols Participants will be thoroughly trained on how to keep accurate food records Participants will be asked to perform 9 randomly selected food records throughout the study Investigators will use the Nutrition Data System for Research NDSR from the University of Minnesota on both campuses for the diet analysis software see NDSR link
Satiety and Hunger ratings Participants will rate their hunger using a rating scale 1-10 before during and after each snack or meal directly on their 9 required food records during each treatment and will use a validated visual analog scale VAS to rate their hunger after consuming their snack or meal with pistachios for the intervention group and randomly chosen snacksmeals for the control group Participants will be given binders with the food record forms and VAS questionnaires in them with the randomly chosen dates and instructions listed Completed forms will be checked for accuracy and collected at the weekly visits from the binders
Physical Activity Questionnaire Participants will be asked to recall their physical activity level over the preceding week 7 day recall using the 2002 International Physical Activity Questionnaire IPAQ short form Participants will be encouraged to maintain their usual levels of physical activity
Chem PanelIron PanelBlood Lipids Blood will be drawn on campus at the Health Center at week 1 and 12 to examine a lipid panel a standard chem panel and iron status The participants will need to fast for 12 hours before the blood draw however consuming 15 cups of water in the morning will be encouraged
Inflammatory Markers Blood will be drawn on campus at the Health Center at week 1 and 12 to examine inflammatory markers ie C-reactive protein CRP tumor necrosis factor alpha TNFa and interleukin-6 IL-6 The participants will need to fast for 12 hours before the blood draw however consuming 15 cups of water in the morning will be encouraged
Markers of Bone Turnover Blood will be drawn on campus at the Health Center at week 1 and 12 to examine markers of bone turnover
Data Collected at the Cal Poly SLO site only
Body CompositionBone Mineral Density DXA Full-body DXA iDXA General Electric Healthcare will be used to determine body fat mass body fat percentages lean body mass and bone mineral density of each subject A pregnancy test will be given to participants before the test to ensure safety of the fetus If positive the participant will be asked to terminate their participation in the study
Data Collected at the Cal Poly Pomona site only
Erythrocyte Membrane Incorporation Lipomics Erythrocytes membranes will be measured for all fatty acids Erythrocytes will be packed in dry ice and shipped overnight to Lipomics Technologies West Sacramento California 95691
Data Analysis A statistician will be consulted and all statistical analyses will be conducted using Statistical Analysis Software SAS version 92 Time-repeated analysis of variance ANOVA will be performed for comparisons between the variables during the two time points and ANOVAs will be performed between the two treatment groups Spearmans correlation will be used to examine associations between the variables
Debriefing of Participants Subjects will be consented to this study and will be aware of the purpose of this study All subjects will be given a copy of the consent form
Results Dissemination Plan
The dissemination plan for the results of this project includes but is not limited to
Publication in peer-reviewed journals ie Journal of Nutrition The Journal of Clinical Nutrition The Journal of the Academy of Nutrition and Dietetics AND the American Journal of Public Health Journal of Family and Consumer Science
Publication in newsletter articles and research bulletins
Publication on the Cal Poly Pomona web site Agriscapes e-mail announcements presentation at poster sessions
Presentation at scientific meetings ie Experimental Biology
1 To examine the effects of a diet rich in pistachios on body composition
2 Examine incorporation of healthy fats into red blood cell RBC membranes
3 Determine changes in blood lipids inflammatory markers and markers of bone turnover with pistachio consumption
4 Assess diet qualitymicronutrient quality and satiety with pistachio consumption
Methods Investigators will employ a crossover design with two 12-week treatment periods pistachio added and a no-pistachio control diet separated by 15-week washout period with 30 healthy students at each campus
Subjects Female students enrolled at CP-SLO and CP-P will be invited to participate in the study The first 30 qualified females will be enrolled in the study at each site A screening questionnaire will determine eligibility The interview will take 5 minutes This sample size provides more than adequate power 80 to detect individual changes
Recruitment Female students enrolled at CP-SLO and CP-P will be invited to participate in the study Potential subjects will be notified by flyers emails adds on marquees and peer recruitment in summer school classes The information on the flyer and emails will be approved by the Institutional Review Boards and contain information regarding inclusionexclusion criteria length of study and the risks and benefits Participants will be asked to contact either Dr Laura Hall CP-SLO or Dr Bonny Burns-Whitmore CP-P and then potential participants will be asked to fill out a screening questionnaire to determine eligibility
Study Design Methods We will employ a randomized crossover design with two 12-week treatment periods pistachio added 20 of kcals and a no-pistachio control diet separated by 15-week washout period with 30 healthy female students at each campus The first treatment period will be in Fall 2012 and the second treatment period will be in Spring 2013
Randomization to treatment pistachios or habitual control diet and 24-hour recalls Randomization will be done utilizing a wwwrandomizationcom list of random appointments to either the treatment group first or the control group first
Materials and Procedures
Study visits Participants will come to the CP-SLO n30 or CP-P n30 site once a week during Fall quarter for 12 weeks and again during Spring quarter for 12 weeks to pick up their pre-measured pistachios for a total of 24 total study visits At the initial visit half the participants will be given pistachios to include in their diet as snacks or in meals 20 percent of kcals intervention group while half will continue their normal diets control group During Spring the other half of the participants will switch and consume the pistachios while the first half will not Diet counseling will also be given at these visits and compliance to study protocols will be evaluated by counting the number of pistachio packages and looking at the participants Unusual Diet Diary At baseline and end of each treatment period participants will have their height weight waist circumference hip circumference body composition measured and blood drawn at both sites At CP-SLO they will also have their bone density measured DXA At the CP-P site they will have a fatty acid analysis performed to examine monounsaturated fatty acid incorporation into red blood cells RBCs
CalculationDistribution of Pistachios and InitialWeekly Study Visits During the lead-in period participants will meet initially and will be trained on keeping their food records by a Registered Dietitian RD During this week they will each keep a 3-day food record and turn it in immediately The researchers will calculate how many pistachios each participant needs based off of the initial 3-day food record This amount will be substituted as 20 percent of their usual caloric need and it will be pre-measured into daily individually-wrapped servings The researches will meet with the participants weekly to give them a weeks supply of their pre-measured packet of pistachios one for each day They will be asked to bring in their used wrappers to the weekly counseling meetings At the weekly counseling meetings participants will be shown how to incorporate the pistachios into their diet either as snacks or in recipes in an isocaloric diet to check the participants unusual diet diary and food records for accuracy to review the MyPlate guidelines and to check the empty pistachio wrappers for compliance Participants will also get emailtext reminders about meetings and reminder instructions on how to prepare for study visits
Data Collected at both sites during Fall 2012 wk 1 and wk 12 Spring 2013 wk 1 and wk 12
Anthropometric Measurements Body weight will be measured using a calibrated scale and recorded to the nearest 01 kg Height will be measured using a stadiometer and recorded to the nearest 01 cm Body mass index BMI will be calculated as weight kg divided by height m squared Waist circumference will be measured using a flexible measuring tape between the middle of the bottom rib and iliac crest top of the hip bone and recorded to the nearest 01 cm Hip circumference will be measured using a flexible measuring tape around the largest part of the hips ie buttocks and recorded to the nearest 01 cm Measurements will be taken twice and averaged We will also calculate their waist-to-hip ratio Protocols will be based on NHANES III standardized procedures and student volunteers will be thoroughly trained on these protocols see link-NHANES Blood Pressure Blood pressure will be taken using an automatic blood pressure monitor Protocol will be based on Mayo Clinic standardized procedures and student volunteers will be thoroughly trained on these protocols see link-Mayo Clinic
Body Composition Measurement Body fat percentage will be assessed by bioelectrical impedance analysis using the Tanita Body Composition Analyzer Scale model TBF-310 from Tanita Corporation Tokyo Japan It will also be used to measure weight body mass index BMI percent body fat impedance fat mass TBF fat free mass FFM total body mass TBM and total body water TBW The participants will need to fast for 12 hours before their study visit ie no caffeine in the morning but 15 cups of water prior to the visit will be encouraged
Food RecordsUnusual Diet Diary ie Dietary Adherence Compliance Adherence and compliance to the assigned diets will be assessed using an Unusual Diet Diary developed at CP-P which is filled out by the participant when unusual quantities of foods or accidental pistachio consumption occurs medical treatment is required a suspected allergic reactionside effect occurs or pharmaceuticals are consumed If a participant experiences an allergic reaction to pistachios they will have been told to call 911 and after contacting the researchers they will be removed from the study to limit further risk Food records will be administered during each treatment to obtain information regarding the subjects diet and determine if the subject is adhering to treatment protocols Participants will be thoroughly trained on how to keep accurate food records Participants will be asked to perform 9 randomly selected food records throughout the study Investigators will use the Nutrition Data System for Research NDSR from the University of Minnesota on both campuses for the diet analysis software see NDSR link
Satiety and Hunger ratings Participants will rate their hunger using a rating scale 1-10 before during and after each snack or meal directly on their 9 required food records during each treatment and will use a validated visual analog scale VAS to rate their hunger after consuming their snack or meal with pistachios for the intervention group and randomly chosen snacksmeals for the control group Participants will be given binders with the food record forms and VAS questionnaires in them with the randomly chosen dates and instructions listed Completed forms will be checked for accuracy and collected at the weekly visits from the binders
Physical Activity Questionnaire Participants will be asked to recall their physical activity level over the preceding week 7 day recall using the 2002 International Physical Activity Questionnaire IPAQ short form Participants will be encouraged to maintain their usual levels of physical activity
Chem PanelIron PanelBlood Lipids Blood will be drawn on campus at the Health Center at week 1 and 12 to examine a lipid panel a standard chem panel and iron status The participants will need to fast for 12 hours before the blood draw however consuming 15 cups of water in the morning will be encouraged
Inflammatory Markers Blood will be drawn on campus at the Health Center at week 1 and 12 to examine inflammatory markers ie C-reactive protein CRP tumor necrosis factor alpha TNFa and interleukin-6 IL-6 The participants will need to fast for 12 hours before the blood draw however consuming 15 cups of water in the morning will be encouraged
Markers of Bone Turnover Blood will be drawn on campus at the Health Center at week 1 and 12 to examine markers of bone turnover
Data Collected at the Cal Poly SLO site only
Body CompositionBone Mineral Density DXA Full-body DXA iDXA General Electric Healthcare will be used to determine body fat mass body fat percentages lean body mass and bone mineral density of each subject A pregnancy test will be given to participants before the test to ensure safety of the fetus If positive the participant will be asked to terminate their participation in the study
Data Collected at the Cal Poly Pomona site only
Erythrocyte Membrane Incorporation Lipomics Erythrocytes membranes will be measured for all fatty acids Erythrocytes will be packed in dry ice and shipped overnight to Lipomics Technologies West Sacramento California 95691
Data Analysis A statistician will be consulted and all statistical analyses will be conducted using Statistical Analysis Software SAS version 92 Time-repeated analysis of variance ANOVA will be performed for comparisons between the variables during the two time points and ANOVAs will be performed between the two treatment groups Spearmans correlation will be used to examine associations between the variables
Debriefing of Participants Subjects will be consented to this study and will be aware of the purpose of this study All subjects will be given a copy of the consent form
Results Dissemination Plan
The dissemination plan for the results of this project includes but is not limited to
Publication in peer-reviewed journals ie Journal of Nutrition The Journal of Clinical Nutrition The Journal of the Academy of Nutrition and Dietetics AND the American Journal of Public Health Journal of Family and Consumer Science
Publication in newsletter articles and research bulletins
Publication on the Cal Poly Pomona web site Agriscapes e-mail announcements presentation at poster sessions
Presentation at scientific meetings ie Experimental Biology
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 002940-CPP Foundation | OTHER_GRANT | American Pistachio Growers | None |
| 082012-CPSLO ARI | OTHER_GRANT | None | None |