Evaluation of milk protein concentrate (MPC) on serum levels of glucose, lipid profile, insulin, adipocytokines and body composition in obese women on a weight-loss diet
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Protocol summary
Inclusion criteria include aged 18 years and older; BMI range of 30 to 40 kg/m2; absence of menopause; lactation; pregnancy; food allergies; not having cancer, hepatic, renal, thyroid and gastrointestinal disorders; no surgery for weight loss; no weight loss over the past 6 months;protein intake range in normal range, no taking herbs and drug that reduce appetite and weight and vitamin-mineral supplements and exclusion criteria is become pregnant during study; unwilling to continue; no consumption of powders exceed 10% of total administered powders.
Inclusion criteria include aged 18 years and older; BMI range of 30 to 40 kg/m2; absence of menopause; lactation; pregnancy; food allergies; not having eating disorders, particularly binge eating disorder (BED), bulimia, not having cancer, hepatic, renal, thyroid and gastrointestinal disorders; no surgery for weight loss; no weight loss over the past 6 months; no taking herbs and drug that reduce appetite and weight and vitamin-mineral supplements and exclusion criteria is become pregnant during study; unwilling to continue; changes in diet during the study period, no consumption of powders exceed 10% of total administered powders.
Inclusion criteria include aged 18 years and older; BMI range of 30 to 40 kg/m2; absence of menopause; lactation; pregnancy; food allergies; not having eating disorders, particularly binge eating disorder (BED), bulimia, not having cancer, hepatic, renal, thyroid and gastrointestinal disorders; no surgery for weight loss; no weight loss over the past 6 months;protein intake range in normal range, no taking herbs and drug that reduce appetite and weight and vitamin-mineral supplements and exclusion criteria is become pregnant during study; unwilling to continue; changes in diet during the study period, no consumption of powders exceed 10% of total administered powders.
معيارهاي ورود شامل سن 18 سال و بالاتر؛ جنسیت زن؛ دارا بودن30 kg/m2 BMI تا 40kg/m2؛ عدم یائسگی؛ عدم شیردهی و بارداری؛عدم آلرژی و حساسیت غذایی؛ عدم ابتلا به بیماری هایی مانند سرطان، بیماری های کبدی، کلیوی، تیروئیدی وگوارشی؛ عدم انجام جراحی برای کاهش وزن؛ عدم کاهش وزن در طول 6 ماه گذشته؛ میزان دریافت غذایی پروتئین در رنج نرمال و عدم مصرف مکمل های ویتامینی، مواد معدنی،گیاهی و داروهای کاهنده اشتها و وزن می باشد. معيارهاي خروج از مطالعه، باردار شدن در طول مداخله؛ عدم تمایل به ادامه همکاری؛ -عدم مصرف پودر MPC به مقدار بیشتر از 10 درصد می باشد.
معيارهاي ورود شامل سن 18 سال و بالاتر؛ جنسیت زن؛ دارا بودن30 kg/m2 BMI تا 40kg/m2؛ عدم یائسگی؛ عدم شیردهی و بارداری؛عدم آلرژی و حساسیت غذایی؛عدم ابتلابه اختلالات خوردن به ویژه اختلال پرخوری،بولیمیا؛ عدم ابتلا به بیماری هایی مانند سرطان، بیماری های کبدی، کلیوی، تیروئیدی وگوارشی؛ عدم انجام جراحی برای کاهش وزن؛ عدم کاهش وزن در طول 6 ماه گذشته و عدم مصرف مکمل های ویتامینی، مواد معدنی،گیاهی و داروهای کاهنده اشتها و وزن می باشد. معيارهاي خروج از مطالعه، باردار شدن در طول مداخله؛ عدم تمایل به ادامه همکاری؛ تغییر در رژیم غذایی در طول مداخله، عدم مصرف پودر MPC به مقدار بیشتر از 10 درصد می باشد.
معيارهاي ورود شامل سن 18 سال و بالاتر؛ جنسیت زن؛ دارا بودن30 kg/m2 BMI تا 40kg/m2؛ عدم یائسگی؛ عدم شیردهی و بارداری؛عدم آلرژی و حساسیت غذایی؛عدم ابتلابه اختلالات خوردن به ویژه اختلال پرخوری،بولیمیا؛ عدم ابتلا به بیماری هایی مانند سرطان، بیماری های کبدی، کلیوی، تیروئیدی وگوارشی؛ عدم انجام جراحی برای کاهش وزن؛ عدم کاهش وزن در طول 6 ماه گذشته؛ میزان دریافت غذایی پروتئین در رنج نرمال و عدم مصرف مکمل های ویتامینی، مواد معدنی،گیاهی و داروهای کاهنده اشتها و وزن می باشد. معيارهاي خروج از مطالعه، باردار شدن در طول مداخله؛ عدم تمایل به ادامه همکاری؛ -تغییر در رژیم غذایی در طول مداخله، عدم مصرف پودر MPC به مقدار بیشتر از 10 درصد می باشد.
General information
2021-02-03, 1399/11/15
2022-04-03, 1401/01/14
20212022-0204-03 00:00:00
2021-06-05, 1400/03/15
2022-09-05, 1401/06/14
20212022-0609-05 00:00:00
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changing the time of the intervention
changing the time of the intervention
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تغییر زمان انجام مطالعه
تغییر زمان انجام مطالعه
aged 18 years and older
female
BMI range of 30 to 40 kg/m2
absence of menopause, lactation and pregnancy
food allergies
not having cancer, hepatic, renal, thyroid and gastrointestinal disorders
no surgery for weight loss
no weight loss over the past 6 months
protein intake range in normal range
no taking herbs and drug that reduce appetite and weight and vitamin-mineral supplements
aged 18 years and older
female
BMI range of 30 to 40 kg/m2
absence of menopause, lactation and pregnancy
food allergies
not having eating disorders, particularly binge eating disorder (BED), bulimia
not having cancer, hepatic, renal, thyroid and gastrointestinal disorders
no surgery for weight loss
no weight loss over the past 6 months
no taking herbs and drug that reduce appetite and weight and vitamin-mineral supplements
aged 18 years and older female BMI range of 30 to 40 kg/m2 absence of menopause, lactation and pregnancy food allergies not having eating disorders, particularly binge eating disorder (BED), bulimia not having cancer, hepatic, renal, thyroid and gastrointestinal disorders no surgery for weight loss no weight loss over the past 6 months protein intake range in normal range no taking herbs and drug that reduce appetite and weight and vitamin-mineral supplements
سن 18 سال و بالاتر
جنسیت زن
دارا بودنBMI 30 kg/m2 تا 40 kg/m2-
عدم یائسگی،شیردهی و بارداری
عدم آلرژی و حساسیت غذایی
عدم ابتلا به بیماری هایی مانند سرطان، بیماری های کبدی، کلیوی، تیروئیدی وگوارشی
عدم انجام جراحی برای کاهش وزن
عدم کاهش وزن در طول 6 ماه گذشته
میزان دریافت غذایی پروتئین در رنج نرمال
عدم مصرف مکمل های ویتامینی، مواد معدنی،گیاهی و داروهای کاهنده اشتها و وزن
سن 18 سال و بالاتر
جنسیت زن
دارا بودنBMI 30 kg/m2 تا 40 kg/m2-
عدم یائسگی،شیردهی و بارداری
عدم آلرژی و حساسیت غذایی
عدم ابتلا به اختلالات خوردن به ویژه اختلال پرخوری، (بولیمیا)
عدم ابتلا به بیماری هایی مانند سرطان، بیماری های کبدی، کلیوی، تیروئیدی وگوارشی
عدم انجام جراحی برای کاهش وزن
عدم کاهش وزن در طول 6 ماه گذشته
عدم مصرف مکمل های ویتامینی، مواد معدنی،گیاهی و داروهای کاهنده اشتها و وزن
سن 18 سال و بالاتر جنسیت زن دارا بودنBMI 30 kg/m2 تا 40 kg/m2- عدم یائسگی،شیردهی و بارداری عدم آلرژی و حساسیت غذایی عدم ابتلا به اختلالات خوردن به ویژه اختلال پرخوری، (بولیمیا) عدم ابتلا به بیماری هایی مانند سرطان، بیماری های کبدی، کلیوی، تیروئیدی وگوارشی عدم انجام جراحی برای کاهش وزن عدم کاهش وزن در طول 6 ماه گذشته میزان دریافت غذایی پروتئین در رنج نرمال عدم مصرف مکمل های ویتامینی، مواد معدنی،گیاهی و داروهای کاهنده اشتها و وزن
become pregnant during study
unwilling to continue
no consumption of powders exceed 10% of total administered powders
become pregnant during study
unwilling to continue
changes in diet during the study period
no consumption of powders exceed 10% of total administered powders
become pregnant during study unwilling to continue changes in diet during the study period no consumption of powders exceed 10% of total administered powders
باردار شدن در طول مداخله
عدم تمایل به ادامه همکاری
عدم مصرف پودر MPC به مقدار بیشتر از 10 درصد
باردار شدن در طول مداخله
عدم تمایل به ادامه همکاری
تغییر رژیم غذایی در طول مداخله
عدم مصرف پودر MPC به مقدار بیشتر از 10 درصد
باردار شدن در طول مداخله عدم تمایل به ادامه همکاری تغییر رژیم غذایی در طول مداخله عدم مصرف پودر MPC به مقدار بیشتر از 10 درصد
Primary outcomes
#1
Glucose
Leptin
GlucoseLeptin
گلوکز
لپتین
گلوکزلپتین
#2
Lipid profile
Adiponectin
Lipid profileAdiponectin
پروفایل لیپیدی
آدیپونکتین
پروفایل لیپیدیآدیپونکتین
#3
Serum Insulin
Body Composition
Serum InsulinBody Composition
انسولین سرم
ترکیب بدنی
انسولین سرمترکیب بدنی
Bloodletting
Body Composition Analyzer
BloodlettingBody Composition Analyzer
خونگیری
با دستگاه آنالیزگر ترکیب بدن
خونگیریبا دستگاه آنالیزگر ترکیب بدن
#4
Leptin
Waist circumference
LeptinWaist circumference
لپتین
دورکمر
لپتیندورکمر
Bloodletting
Tape measure
BloodlettingTape measure
خونگیری
نوار متر
خونگیرینوار متر
#5
Adiponectin
Body Mass Index
AdiponectinBody Mass Index
آدیپونکتین
شاخص توده بدنی
آدیپونکتینشاخص توده بدنی
Bloodletting
calculated as body weight(kg)divided by the height in meters square
Bloodlettingcalculated as body weight(kg)divided by the height in meters square
خونگیری
بر حسب کیلوگرم بر متر مربع
خونگیریبر حسب کیلوگرم بر متر مربع
#6
Body Composition
empty
Body Composition
ترکیب بدنی
empty
ترکیب بدنی
Before and 2 months after the intervention
empty
Before and 2 months after the intervention
قبل ودو ماه بعد از شروع مداخله
empty
قبل ودو ماه بعد از شروع مداخله
Body Composition Analyzer
empty
Body Composition Analyzer
با دستگاه آنالیزگر ترکیب بدن
empty
با دستگاه آنالیزگر ترکیب بدن
#7
appetite
empty
appetite
اشتها
empty
اشتها
Before and 2 months after the intervention
empty
Before and 2 months after the intervention
قبل ودو ماه بعد از شروع مداخله
empty
قبل ودو ماه بعد از شروع مداخله
questionnaire
empty
questionnaire
پرسشنامه
empty
پرسشنامه
#8
weight
empty
weight
وزن
empty
وزن
Before and 2 months after the intervention
empty
Before and 2 months after the intervention
قبل ودو ماه بعد از شروع مداخله
empty
قبل ودو ماه بعد از شروع مداخله
Seca scale-kg
empty
Seca scale-kg
با ترازو بر حسب کیلوگرم
empty
با ترازو بر حسب کیلوگرم
Secondary outcomes
#1
empty
Fasting Blood Sugar
Fasting Blood Sugar
empty
قند خون ناشتا
قند خون ناشتا
empty
Before and 2 months after the intervention
Before and 2 months after the intervention
empty
قبل ودو ماه بعد از شروع مداخله
قبل ودو ماه بعد از شروع مداخله
empty
Bloodletting
Bloodletting
empty
خونگیری
خونگیری
#2
empty
Lipid Profile
Lipid Profile
empty
پروفایل لیپیدی
پروفایل لیپیدی
empty
Before and 2 months after the intervention
Before and 2 months after the intervention
empty
قبل ودو ماه بعد از شروع مداخله
قبل ودو ماه بعد از شروع مداخله
empty
Bloodletting
Bloodletting
empty
خونگیری
خونگیری
#3
empty
Fasting Plasma Insulin
Fasting Plasma Insulin
empty
انسولین پلاسما ناشتا
انسولین پلاسما ناشتا
empty
Before and 2 months after the intervention
Before and 2 months after the intervention
empty
قبل ودو ماه بعد از شروع مداخله
قبل ودو ماه بعد از شروع مداخله
empty
Bloodletting
Bloodletting
empty
خونگیری
خونگیری
#4
empty
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
empty
مقاومت به انسولين HOMA-IR
مقاومت به انسولين HOMA-IR
empty
Before and 2 months after the intervention
Before and 2 months after the intervention
empty
قبل ودو ماه بعد از شروع مداخله
قبل ودو ماه بعد از شروع مداخله
empty
Bloodletting
Bloodletting
empty
خونگیری
خونگیری
#5
empty
Appetite
Appetite
empty
اشتها
اشتها
empty
Before and 2 months after the intervention
Before and 2 months after the intervention
empty
قبل ودو ماه بعد از شروع مداخله
قبل ودو ماه بعد از شروع مداخله
empty
Questionnaire
Questionnaire
empty
پرسشنامه
پرسشنامه
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: دکتر مهدی احمدی مقدم
Full name of responsible person - Persian: Dr.Mahdi Ahmadi Moghadam
Street address - English: Gholestan highway.Ahvaz
Street address - Persian: اهواز.اتوبان گلستان
City - English: ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 1579461357
Phone: +98 61 3333 9092
Fax:
Email: ahmadi-m@ajums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Mahdi Ahmadi Moghadam
Full name of responsible person - Persian: دکتر مهدی احمدی مقدم
Street address - English: Gholestan highway.Ahvaz
Street address - Persian: اهواز.اتوبان گلستان
City - English: ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 1579461357
Phone: +98 61 3333 9092
Fax:
Email: ahmadi-m@ajums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: دکتر مهدی احمدی مقدمDr.Mahdi Ahmadi Moghadam Full name of responsible person - Persian: Dr.Mahdi Ahmadi Moghadamدکتر مهدی احمدی مقدم Street address - English: Gholestan highway.Ahvaz Street address - Persian: اهواز.اتوبان گلستان City - English: ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 1579461357 Phone: +98 61 3333 9092 Fax: Email: ahmadi-m@ajums.ac.ir Web page address:
Protocol summary
Study aim
This is a clinical trial with the goal of determine the Evaluation of milk protein concentrate (MPC) on serum levels of glucose, lipid profile, insulin, adipocytokines and body composition in obese women on a weight-loss diet.
Design
Each of intervention group subjects, will receive 30grams milk protein concentration (MPC) powders per day for 2 months.Each subject will be interviewed with a questionnaire to collect demographic, physical activity and 24 hr recall information. At baseline and end of trial, 10ml of venous blood samples will be collected after overnight fasting. All participants will follow a hypo-caloric diet of 800 kcal below estimated energy requirements.
Settings and conduct
obese women reffered to Diet therapy clinic of Abadan Imam Khomeini Hospital will intake 30gr MPC powder supplement per day for 2 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria include aged 18 years and older; BMI range of 30 to 40 kg/m2; absence of menopause; lactation; pregnancy; food allergies; not having eating disorders, particularly binge eating disorder (BED), bulimia, not having cancer, hepatic, renal, thyroid and gastrointestinal disorders; no surgery for weight loss; no weight loss over the past 6 months; no taking herbs and drug that reduce appetite and weight and vitamin-mineral supplements and exclusion criteria is become pregnant during study; unwilling to continue; changes in diet during the study period, no consumption of powders exceed 10% of total administered powders.
Intervention groups
Eligible subjects will be stratified according to age and BMI randomly assigned to one of two groups: control (standard weight loss group, n=22) and intervention (milk protein concentration (MPC) supplementation weight loss group, n=22).
Main outcome variables
serum levels of glucose, lipid profile, insulin, adipocytokines and body composition
General information
Reason for update
changing the time of the intervention
Acronym
IRCT registration information
IRCT registration number:IRCT20201223049804N1
Registration date:2021-01-10, 1399/10/21
Registration timing:prospective
Last update:2022-08-15, 1401/05/24
Update count:1
Registration date
2021-01-10, 1399/10/21
Registrant information
Name
Mahsa Elahikhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5322 7942
Email address
mahsa.elahikhah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2022-09-05, 1401/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of milk protein concentrate (MPC) on serum levels of glucose, lipid profile, insulin, adipocytokines and body composition in obese women on a weight-loss diet
Public title
Evaluation of milk protein concentrate (MPC) on weight-loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aged 18 years and older
female
BMI range of 30 to 40 kg/m2
absence of menopause, lactation and pregnancy
food allergies
not having eating disorders, particularly binge eating disorder (BED), bulimia
not having cancer, hepatic, renal, thyroid and gastrointestinal disorders
no surgery for weight loss
no weight loss over the past 6 months
no taking herbs and drug that reduce appetite and weight and vitamin-mineral supplements
Exclusion criteria:
become pregnant during study
unwilling to continue
changes in diet during the study period
no consumption of powders exceed 10% of total administered powders
Age
From 18 years old to 48 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly stratified according to age and BMI using a permuted block randomization procedure by Random Allocation Software (RAS). They will be assigned to one of the two study groups:
(1) Standard weight loss group (n=22) (control group)
(2) MPC supplementation weight loss group (n=22) (intervention group)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz-Gholestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2021-01-03, 1399/10/14
Ethics committee reference number
IR.AJUMS.REC.1399.795
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Leptin
Timepoint
Before and 2 months after the intervention
Method of measurement
Bloodletting
2
Description
Adiponectin
Timepoint
Before and 2 months after the intervention
Method of measurement
Bloodletting
3
Description
Body Composition
Timepoint
Before and 2 months after the intervention
Method of measurement
Body Composition Analyzer
4
Description
Waist circumference
Timepoint
Before and 2 months after the intervention
Method of measurement
Tape measure
5
Description
Body Mass Index
Timepoint
Before and 2 months after the intervention
Method of measurement
calculated as body weight(kg)divided by the height in meters square
Secondary outcomes
1
Description
Fasting Blood Sugar
Timepoint
Before and 2 months after the intervention
Method of measurement
Bloodletting
2
Description
Lipid Profile
Timepoint
Before and 2 months after the intervention
Method of measurement
Bloodletting
3
Description
Fasting Plasma Insulin
Timepoint
Before and 2 months after the intervention
Method of measurement
Bloodletting
4
Description
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Timepoint
Before and 2 months after the intervention
Method of measurement
Bloodletting
5
Description
Appetite
Timepoint
Before and 2 months after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Isocaleric weight loss diet and milk protein concentration (MPC) powders will be prescribed. Each of intervention group subjects, will receive 30 gram milk protein concentration (MPC) powders per day.
Category
Treatment - Other
2
Description
Control group: will receive standard weight loss (macronutrients percent will be carbohydrate55%, fat 30% and 15% protein).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diet Therapy Clinic of Abadan Imam Khomeini hospital
Full name of responsible person
Mahsa Elahikhah
Street address
Shahid Montazeri
City
Abadan
Province
Khouzestan
Postal code
63168481111
Phone
+98 61 5322 2443
Email
mahsa.elahikhah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Mahdi Ahmadi Moghadam
Street address
Gholestan highway.Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3333 9092
Email
ahmadi-m@ajums.ac.ir
Grant name
nrc-9912
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Elahikhah
Position
M.Sc student of Nutrition Science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Ahvaz,Gholestan highway,Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3333 9092
Email
mahsa.elahikhah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Haidari Fatemeh
Position
Nutrition Sciences Phd
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ahvaz.Gholestan highway.Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3333 9092
Email
haidari58@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Elahikhah
Position
M.Sc student of Nutrition Science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Ahvaz.Gholestan highway.Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3333 9092
Email
mahsa.elahikhah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available