- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03978104
Impact of Okara and Bio-okara Food Product on Gut and Glycaemic Health in Middle-aged and Older Adults in Singapore
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For this double-blind, randomized, crossover experiment, the participants will complete a 16-week study period. Following a 1-wk pre-intervention baseline period, each participant will be randomly assigned to consume their habitual diet that either contains or do not contain okara food product (untreated and bio-transformed okara) for 3 weeks. The food product will be equivalent to a consumption of 20 g of okara (dried) per day. Following a 3-week dietary 'washout' period, the participants will be assigned to consume the other diets for another 3 weeks. This process will be repeated until each participant have completed all three interventions. Fecal and fasting-state blood samples will be obtained at study weeks 1, 4, 7, 10, 13, and 16, which correspond to before and end of the three 3-week intervention periods.
Additionally, during Weeks 1, 7 and 13, fasted participants will also be required to undergo a meal tolerance test. A cannula will first be inserted into the participant's forearm for blood sampling by a trained phlebotomist. One of three meals prepared by designated study personnel will then be randomly assigned during each visit, namely, control biscuit, untreated okara biscuit and bio-transformed okara biscuit. During each test, the participants will eat the prepared meal within 10 minutes and have blood samples drawn by intravenous cannulation at time = 0, 15, 30, 45, 60, 90, 120, 180 and 240 min, with time 0 being the time the participants first start eating the biscuits. The blood samples will analyzed for the postprandial blood glucose, insulin responses and lipid levels.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Singapore, Singapore, 117546
- Department of Food Science and Technology; National University of Singapore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ability to give an informed consent
- Age 50 to 75 years
- Willing to follow the study procedures
Exclusion Criteria:
All subjects meeting any of the exclusion criteria at baseline will be excluded from participation
- Significant change in weight (≥ 3 kg body weight) during the past 3 months
- Allergy to soy-based products
- Acute illness at the study baseline
- Exercising vigorously over the past 3 months
- Following any restricted diet (e.g. vegetarian)
- Smoking
- Have a daily intake of more than 2 alcoholic drinks per day
- Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 5 years prior to the intervention participation
- Taking dietary supplements which may impact the outcome of interests (e.g. vitamin supplements, probiotic supplement etc.)
- Pregnant, lactating, or planning pregnancy in the next 6 months
- Insufficient venous access to allow the blood collection
- Very high intake of fibre/ vegetables on a daily basis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Okara biscuits
Subjects will consume their habitual diet with daily okara biscuit consumption accounting to 20 grams/ day of dry okara powder for 21 days.
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Consumption of okara-enriched biscuits together with habitual diet.
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Experimental: Bio-okara biscuits
Subjects will consume their habitual diet with daily bio-okara biscuit consumption accounting to 20 grams/ day of dry bio-okara powder for 21 days.
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Consumption of bio-okara-enriched biscuits together with habitual diet.
Bio-okara is a form of fermented okara.
Other Names:
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Experimental: Control biscuits
Subjects will consume their habitual diet with daily control biscuit consumption for 21 days.
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Consumption of control biscuits together with habitual diet.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gut microbiome composition before and after a 3 week intervention.
Time Frame: Baseline and post-intervention (at 3 weeks)
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Gut microbiome composition will be determined via fecal samples of subjects at baseline and after each intervention period.
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Baseline and post-intervention (at 3 weeks)
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Change in fecal short chain fatty acids (SCFA) before and after a 3 week intervention.
Time Frame: Baseline and post-intervention (at 3 weeks)
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SCFA will be determined via fecal samples of subjects at baseline and after each intervention period.
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Baseline and post-intervention (at 3 weeks)
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Change in serum short chain fatty acids (SCFA) before and after a 3 week intervention.
Time Frame: Baseline and post-intervention (at 3 weeks)
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SCFA will be determined via serum samples of subjects at baseline and after each intervention period.
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Baseline and post-intervention (at 3 weeks)
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Change in fecal bile acids before and after a 3 week intervention.
Time Frame: Baseline and post-intervention (at 3 weeks)
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Bile acids will be determined via serum samples of subjects at baseline and after each intervention period.
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Baseline and post-intervention (at 3 weeks)
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Change in serum zonulin before and after a 3 week intervention.
Time Frame: Baseline and post-intervention (at 3 weeks)
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Serum zonulin will be determined via serum samples of subjects at baseline and after each intervention period.
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Baseline and post-intervention (at 3 weeks)
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Change in blood glucose levels before and after a 3 week intervention.
Time Frame: Baseline and post-intervention (at 3 weeks)
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Glucose levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
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Baseline and post-intervention (at 3 weeks)
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Change in blood insulin levels before and after a 3 week intervention.
Time Frame: Baseline and post-intervention (at 3 weeks)
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Insulin levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
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Baseline and post-intervention (at 3 weeks)
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Change in blood triglyceride levels before and after a 3 week intervention.
Time Frame: Baseline and post-intervention (at 3 weeks)
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Total triglyceride levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
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Baseline and post-intervention (at 3 weeks)
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Change in blood cholesterol levels before and after a 3 week intervention.
Time Frame: Baseline and post-intervention (at 3 weeks)
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Total cholesterol levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
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Baseline and post-intervention (at 3 weeks)
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Change in blood low-density lipoprotein-cholesterol levels before and after a 3 week intervention.
Time Frame: Baseline and post-intervention (at 3 weeks)
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Low-density lipoprotein-cholesterol levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
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Baseline and post-intervention (at 3 weeks)
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Change in blood high-density lipoprotein-cholesterol levels before and after a 3 week intervention.
Time Frame: Baseline and post-intervention (at 3 weeks)
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High-density lipoprotein-cholesterol levels will be determined via fasted blood samples of subjects at baseline and after each intervention period.
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Baseline and post-intervention (at 3 weeks)
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Change in blood glucose levels over acute trial period
Time Frame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Glucose levels will be determined via fasted blood samples of subjects and after consumption of intervention
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Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Change in blood insulin levels over acute trial period
Time Frame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Insulin levels will be determined via fasted blood samples of subjects and after consumption of intervention
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Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Change in blood short-chain fatty acids levels over acute trial period
Time Frame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Short-chain fatty acids levels will be determined via fasted blood samples of subjects and after consumption of intervention
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Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Change in blood amino acid levels over acute trial period
Time Frame: Time 0, 15, 30, 45, 60, 90, 120 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Amino acid levels will be determined via fasted blood samples of subjects and after consumption of intervention
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Time 0, 15, 30, 45, 60, 90, 120 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood pressure
Time Frame: Baseline and post-intervention (at 3 weeks)
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Blood pressure
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Baseline and post-intervention (at 3 weeks)
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Change in anthropometric measurements
Time Frame: Baseline and post-intervention (at 3 weeks)
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Waist circumference
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Baseline and post-intervention (at 3 weeks)
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Change in anthropometric measurements
Time Frame: Baseline and post-intervention (at 3 weeks)
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Weight
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Baseline and post-intervention (at 3 weeks)
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Change in anthropometric measurements
Time Frame: Baseline
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Height
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Baseline
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Dietary assessment
Time Frame: Baseline and post-intervention (at 3 weeks)
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Dietary questionnaires (3-day food record)
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Baseline and post-intervention (at 3 weeks)
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Stool assessment
Time Frame: Baseline and post-intervention (at 3 weeks)
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Stool sampling questionnaire will be completed by subjects, which notes down food or alcohol consumed over the past 24 hours prior to collection, any discomfort, pain or bloating, flatulence, noticable changes in stool frequency or consistency, any blood in stool and any type of medication consumed over the past 3 months.
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Baseline and post-intervention (at 3 weeks)
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Stool assessment
Time Frame: Baseline and post-intervention (at 3 weeks)
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Bristol stool chart (Ranging from Type 1 to Type 7, with Type 3 or 4 being ideal.
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Baseline and post-intervention (at 3 weeks)
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Sleep quality assessment
Time Frame: Baseline and post-intervention (at 3 weeks)
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Pittsburgh sleep quality index questionnaire, with 7 different components assessing sleep and each component making up a minimum or 0 and maximum of 3 points.
The full scale ranges from 0 to 21, with a lower score indicative of a better quality of sleep.
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Baseline and post-intervention (at 3 weeks)
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Sleep quality assessment
Time Frame: Baseline and post-intervention (at 3 weeks)
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Sleep evaluation questionnaire (survey) to assess eligibility for studies with sleep involved
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Baseline and post-intervention (at 3 weeks)
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Cognitive assessment
Time Frame: Baseline and post-intervention (at 3 weeks)
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Montreal cognitive assessment
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Baseline and post-intervention (at 3 weeks)
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Appetite assessment
Time Frame: Baseline and post-intervention (at 3 weeks)
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Visual analogue scale, with unit of measure being units on a scale
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Baseline and post-intervention (at 3 weeks)
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Change in blood amino acids levels over acute trial period
Time Frame: Time 0, 15, 30, 45, 60, 90, 120 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Amino acid levels will be determined via fasted blood samples of subjects and after consumption of intervention
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Time 0, 15, 30, 45, 60, 90, 120 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Change in blood triglyceride levels over acute trial period
Time Frame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Total triglyceride levels will be determined via fasted blood samples of subjects and after consumption of intervention
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Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Change in blood cholesterol levels over acute trial period
Time Frame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Total cholesterol levels will be determined via fasted blood samples of subjects and after consumption of intervention
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Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Change in blood low-density lipoprotein-cholesterol levels over acute trial period
Time Frame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
|
Low-density lipoprotein-cholesterol levels will be determined via fasted blood samples of subjects and after consumption of intervention
|
Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
|
Change in blood high-density lipoprotein-cholesterol levels over acute trial period
Time Frame: Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
|
High-density lipoprotein-cholesterol levels will be determined via fasted blood samples of subjects and after consumption of intervention
|
Time 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes held on pre- intervention arm visit (Every 6 weeks, up to 12 weeks).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jung Eun Kim, National University, Singapore
Publications and helpful links
General Publications
- Vong, W.C., X.Y. Hua, and S.-Q. Liu, Solid-state fermentation with Rhizopus oligosporus and Yarrowia lipolytica improved nutritional and flavour properties of okara. Lwt, 2018. 90: p. 316-322.
- Yogo, T., et al., Influence of Dried Okara-Tempeh on the Composition and Metabolites of Fecal Microbiota in Dogs. International Journal of Applied Research in Veterinary Medicine, 2011. 9(2): p. 176-183.
- Jimenez-Escrig A, Tenorio MD, Espinosa-Martos I, Ruperez P. Health-promoting effects of a dietary fiber concentrate from the soybean byproduct okara in rats. J Agric Food Chem. 2008 Aug 27;56(16):7495-501. doi: 10.1021/jf800792y. Epub 2008 Jul 18.
- Lu, F., Y. Liu, and B. Li, Okara dietary fiber and hypoglycemic effect of okara foods. Bioactive Carbohydrates and Dietary Fibre, 2013. 2(2): p. 126-132.
- Lee DPS, Gan AX, Sutanto CN, Toh KQX, Khoo CM, Kim JE. Postprandial glycemic and circulating SCFA concentrations following okara- and biovalorized okara-containing biscuit consumption in middle-aged and older adults: a crossover randomized controlled trial. Food Funct. 2022 Sep 22;13(18):9687-9699. doi: 10.1039/d2fo00526c.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
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
- S4
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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