- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05400005
Impact of Different Types of Higher Dietary Protein Intake on Sleep Quality in Singapore Older Adults
Today, insufficient sleep has become a growing global problem. Sleep is essential to health and changes in sleep patterns are a part of the aging process. Inadequate and low-quality sleep also increases the risk for age-related cognitive decline and disease conditions. More importantly, due to COVID-19 health emergency, there is a significant increase of psychological distress and symptoms of mental illness and a worsening of quality of sleep. Therefore, there is an urgent need to investigate the way of improving sleep quality, in particular during and post COVID-19 period, in older adults.
One of the possible strategies in improving sleep quality with lifestyle modification is having higher-protein diet. However, this effect has not been fully elucidated in older adults. In addition, the effect of type of dietary protein on sleep quality is inconclusive and there is no clinical trial which assessed the differential response in sleep quality between animal-sourced protein vs. plant-sourced protein. Therefore, the purpose of this research project is to assess the impact of different types of higher dietary protein intake on sleep quality in Singapore older adults.
Findings from the proposed research will provide the scientific evidence of the beneficial effects of regularly consuming higher-protein diet on sleep quality in Singapore older adults. In addition, this research may validate the differential effect of different type of dietary protein on sleep quality. The results from the proposed research will also assist a practical guidance of nutritional behaviour changes providing sleep promoting effects to a large proportion of the Singapore population.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clarinda N Sutanto, PhD
- Phone Number: 65 83787674
- Email: cnsfst@nus.edu.sg
Study Contact Backup
- Name: Jung Eun Kim, PhD
- Phone Number: 65 6516 1136
- Email: fstkje@nus.edu.sg
Study Locations
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Singapore, Singapore, 117546
- Recruiting
- National University of Singapore
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Contact:
- Clarinda N Sutanto, PhD
- Phone Number: 65 83787674
- Email: cnsfst@nus.edu.sg
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Principal Investigator:
- Ian Mak, B.Sc. (Hons)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults 60-85 years old
- Not following HPB diet
Exclusion Criteria:
- Weight change > 3kg in the past 3 months
- Exercise vigorously over the past 3 months
- Drinking more than 2 alcoholic drinks per day
- (if applicable) Pre-menopausal women
- Taking dietary supplements or medications which may impact sleep outcomes (e.g. Nutritional Shakes (e.g. Ensure), Trp, 5-HTP or melatonin supplementations) the past 1 month
- Taking dietary supplements which may impact the gut microbiota (e.g. antibiotics, prebiotics, probiotics) the past 2 months (a list of fermented foods)
- Impaired renal function (normal values: estimated glomerular filtration rate ≥ 90 mL/min/1.73 m2 calculated by chronic kidney disease epidemiology collaboration equation; CKD EPI)
- Soy intolerance and/or allergy or any medical conditions that may be affected by consumption of soy products (e.g. gout)
- Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication or Chinese medicine herb which started less than 3 years prior to the intervention participation
- Diagnosed with gut/gastrointestinal issues such as lactose intolerance and irritable bowel syndrome (IBS)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Normal protein diet (control)
Subjects are to consume normal-protein diet based on the "My Healthy Plate" diet (launched by Health Promotion Board of Singapore) for the duration of the 16-week study.
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Experimental: High protein diet (soy)
Subjects are to consume higher-protein diet by following the "My Healthy Plate" diet (launched by Health Promotion Board of Singapore) and 20g of soy protein isolate for the duration of the 16-week study.
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Intervention of the study include consuming a higher protein diet.
Depending on the group allocation, this is done by asking the subjects to follow "My Healthy Plate" diet and consumption of 20g of protein isolates (casein or soy).
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Experimental: High protein diet (Micellar Casein)
Subjects are to consume higher-protein diet by following the "My Healthy Plate" diet (launched by Health Promotion Board of Singapore) and 20g of micellar casein isolate for the duration of the 16-week study.
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Intervention of the study include consuming a higher protein diet.
Depending on the group allocation, this is done by asking the subjects to follow "My Healthy Plate" diet and consumption of 20g of protein isolates (casein or soy).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in sleep quality assessed by validated sleep questionnaires
Time Frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Pittsburgh Sleep Quality Index Questionnaire (PSQI) will be used to assess the sleep quality.
Overall score ranging from 0 to 21 points, where lower scores denote a healthier sleep quality.
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Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Change in sleep quality assessed by electronic equipment
Time Frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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An electronic equipment, actigraphy, will be used to assess the sleep quality, including sleep timing and wake up timing.
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Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Change in blood amino acid concentration
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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Amino acid concentration in the blood will be measured
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in blood serotonin concentration
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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Serotonin concentration in the blood will be measured
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in urinary 6-sulfatoxymelatonin (aMT6s) concentration
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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6-sulfatoxymelatonin (aMT6s) concentration in the urine samples will be measured
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Every 8 weeks (week 0 , week 8 and week 16)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fecal microbiome composition
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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High-throughput sequencing method (using Illumina MiSeq platforms) will be used to assess the changes in gut microbiome composition
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in fecal short chain fatty acid (SCFA) concentration
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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SCFA concentration in fecal samples will be measured.
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in serum lipopolysaccharide binding protein (LBP) concentration
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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LBP concentration in blood samples will be measured.
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in blood short chain fatty acid (SCFA) concentration
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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SCFA concentration in the blood will be measured
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in fecal bile acids
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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Bile acids concentration will be determined from fecal samples of the subjects
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in fecal zonulin
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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Zonulin concentration will be determined from fecal samples of the subjects
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in fecal calprotectin
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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Calprotectin concentration will be determined from fecal samples of the subjects
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in urinary creatinine concentration
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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Creatinine concentration in the urine samples will be measured
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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The estimated Glomerular Filtration Rate (eGFR) of the subjects will be measured from the blood
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in Trimethylamine N-oxide (TMAO)
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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Trimethylamine N-oxide (TMAO) concentration in the blood will be measured
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in Blood Glucose
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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Glucose concentration in the blood will be measured
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in Blood Triglyceride
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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Triglyceride concentration in the blood will be measured
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in Blood Cholesterol
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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Total cholesterol concentration in the blood will be measured
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in Blood Low-density Lipoprotein-cholesterol (LDL)
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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LDL concentration in the blood will be measured
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in Blood High-density Lipoprotein-cholesterol (LDL)
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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HDL concentration in the blood will be measured
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in Blood Advanced Glycation End-product (AGEs)
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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AGEs concentration in the blood will be measured
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in Skin Advanced Glycation End-product (AGEs)
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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Using a scanner, the AGEs levels in the skin will be measured
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in Blood Interleukin-6 (IL-6)
Time Frame: Every 8 weeks (week 0 , week 8 and week 16)
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Interleukin-6 (IL-6) concentration in the blood will be measured
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Every 8 weeks (week 0 , week 8 and week 16)
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Change in Endothelial Function
Time Frame: Baseline and Post-intervention (week 0 and week 16)
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Endothelial functions are determined by the function of endothelial progenitor cells
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Baseline and Post-intervention (week 0 and week 16)
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Change in Flow Mediate Dilation
Time Frame: Baseline and Post-intervention (week 0 and week 16)
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Flow mediate dilation (%)
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Baseline and Post-intervention (week 0 and week 16)
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Change in weight and height
Time Frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
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Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Change in waist circumference
Time Frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Waist circumference (in cm) will be measured
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Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Change in blood pressure
Time Frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.
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Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Dietary assessment
Time Frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Dietary assessment will be assessed by 3-day dietary food record
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Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Change in mood (stress)
Time Frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Perceived Stress Scale (PSS) will be used to assess the stress levels
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Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Change in mood (depression)
Time Frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Geriatric Depression Scale (GDS) Assessment will be used to assess the depression status
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Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Change in mood (anxiety)
Time Frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Geriatric Anxiety Inventory (GAI) Assessment will be used to assess the anxiety status.
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Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jung Eun Kim, PhD, National University of Singapore
Publications and helpful links
General Publications
- Cappuccio FP, D'Elia L, Strazzullo P, Miller MA. Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. Sleep. 2010 May;33(5):585-92. doi: 10.1093/sleep/33.5.585.
- Zhou J, Kim JE, Armstrong CL, Chen N, Campbell WW. Higher-protein diets improve indexes of sleep in energy-restricted overweight and obese adults: results from 2 randomized controlled trials. Am J Clin Nutr. 2016 Mar;103(3):766-74. doi: 10.3945/ajcn.115.124669. Epub 2016 Feb 10.
- St-Onge MP, Crawford A, Aggarwal B. Plant-based diets: Reducing cardiovascular risk by improving sleep quality? Curr Sleep Med Rep. 2018 Mar;4(1):74-78. Epub 2018 Feb 5.
- Sutanto CN, Wang MX, Tan D, Kim JE. Association of Sleep Quality and Macronutrient Distribution: A Systematic Review and Meta-Regression. Nutrients. 2020 Jan 2;12(1):126. doi: 10.3390/nu12010126.
- Saidi O, Rochette E, Dore E, Maso F, Raoux J, Andrieux F, Fantini ML, Merlin E, Pereira B, Walrand S, Duche P. Randomized Double-Blind Controlled Trial on the Effect of Proteins with Different Tryptophan/Large Neutral Amino Acid Ratios on Sleep in Adolescents: The PROTMORPHEUS Study. Nutrients. 2020 Jun 24;12(6):1885. doi: 10.3390/nu12061885.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- S19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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