Protocol summary

Study aim
The Efficacy of the Herbal Supplement Nutrition Bio-Shield (NBS) Superfood in Improving Nutritional, Clinical, and Laboratory Outcomes in Patients After Bariatric Surgery: A Double-Blind Clinical Trial
Design
This is a phase 1-2 randomized, double-blind, parallel-group, controlled clinical trial conducted on 66 patients. Randomization was performed using the RAND function in Microsoft Excel.
Settings and conduct
Investigators, nurses, and statisticians are blinded to the group allocation of patients. This clinical trial will be conducted in university hospitals in Tehran. The intervention group (33 patients) will receive NBS powder for 6 months in addition to the routine treatment prescribed by the attending physician. The control group (33 patients) will receive the same treatment plan along with a placebo for 6 months. Demographic and laboratory parameters specified in this study will be collected and recorded for all patients before and after the intervention. Finally, statistical methods will be used to analyze the significance of the results.
Participants/Inclusion and exclusion criteria
Patients of all ages were enrolled immediately after bariatric surgery if they had a body mass index (BMI) above 40 kg per m² or a BMI above 35 kg per m² with one or more significant comorbidities. A recent history of medication use, including corticosteroids, NSAIDs, benzodiazepines, and others, was considered a primary exclusion criterion for participation in the study.
Intervention groups
The intervention group will receive 4.5 grams of NBS powder daily, divided into three doses of 1.5 grams, for a duration of 6 months alongside standard treatment. The control group will also receive the standard treatment plan along with a placebo.
Main outcome variables
Serum Levels of Micronutrients, Serum Inflammatory Markers, Lipid Profile, Liver and Kidney Function Assessment, Blood Glucose Levels

General information

Reason for update
Acronym
NBS-Bariatric
IRCT registration information
IRCT registration number: IRCT20241218064090N2
Registration date: 2025-01-05, 1403/10/16
Registration timing: prospective

Last update: 2025-01-05, 1403/10/16
Update count: 0
Registration date
2025-01-05, 1403/10/16
Registrant information
Name
Mehrdad Mosadegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 935 563 3390
Email address
m-mosadegh@alumnus.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-01-20, 1403/11/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of the herbal supplement Nutrition Bio-Shield (NBS) Superfood in improving the nutritional, clinical, and laboratory status of patients after bariatric surgery in a double-blind clinical trial.
Public title
The efficacy of NBS in the complications of patients following bariatric surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index (BMI) above 40 kg/m². Body mass index (BMI) above 35 kg/m² with one or more significant comorbidities (when the individual has been unsuccessful with less invasive weight loss methods or is at high risk of obesity-related complications and mortality).
Exclusion criteria:
Patient withdrawal from the study. Recent history of NSAID (Non-Steroidal Anti-Inflammatory Drugs) use (initiated within the past month). Recent history of corticosteroid use (initiated within the past month). Recent history of benzodiazepine use (initiated within the past month) Recent history of calcium channel blocker use (initiated within the past month) Recent history of nitrate use (initiated within the past month) Recent history of alcohol use (initiated within the past month) Recent history of dietary supplement use or need for other supplements during the study (Note: If the patient requires another supplement as prescribed by the physician, they will be excluded from the study) Recent history of beta-2 agonist use (initiated within the past month) Patients who fail to attend follow-up appointments as scheduled Pregnant and breastfeeding mothers Any signs of drug allergies, as diagnosed by the attending physician Worsening of clinical symptoms due to NBS powder consumption, as determined by the attending physician
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated into two groups: intervention and control, using a random block design. The allocation of samples to the two groups will follow a randomization block scheme with blocks of four. The letter "A" will represent the intervention group and the letter "B" will represent the control group. All possible random combinations of the letters A and B (i.e., AABB, ABBA, ABAB, BAAB, BABA, BBAA) will be written on 6 cards, representing 6 different combinations. Then, a random number from 1 to 6 will be selected, and this process will continue until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding in this study, different groups, including patients, clinical caregivers, and data analysts, were completely unaware of the allocation of treatment groups. In other words, neither the participants nor the medical team had any information regarding which group of patients would receive NBS. Only the treating physician, responsible for assessing and preventing potential side effects related to the consumption of NBS, was aware of the group receiving the NBS powder. Additionally, data collectors and outcome assessors, including those involved in data analysis, were unaware of the allocation to different groups and this had no influence on their assessments or judgments. This process was designed to maintain the scientific integrity of the study and prevent any bias or errors in evaluating the results.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Ramsar Campus- Mazandaran University of medical sciences
Street address
Opposite the Department of Education, Sakht Sar 3, Sakht Sar Street, Enghelab Square, Ramsar
City
Ramsar
Province
Mazandaran
Postal code
4691710001
Approval date
2024-12-08, 1403/09/18
Ethics committee reference number
IR.MAZUMS.RIB.REC.1403.081

Health conditions studied

1

Description of health condition studied
Post-Bariatric Surgery Complications
ICD-10 code
K95
ICD-10 code description
Complications of bariatric procedures

Primary outcomes

1

Description
Measurement of Micronutrient Levels
Timepoint
Before the intervention, after the completion of the intervention
Method of measurement
Autoanalyzer, ELISA, and Electrochemiluminescence

Secondary outcomes

1

Description
Serum Levels of Calcium, Phosphorus, and Magnesium
Timepoint
Before the intervention, after the completion of the intervention
Method of measurement
Autoanalyzer

2

Description
Levels of Inflammatory Markers such as ESR and CRP
Timepoint
Before the intervention, after the completion of the intervention
Method of measurement
Autoanalyzer and Westergren Method

3

Description
Lipid Profile Levels, including Cholesterol, Triglycerides, LDL, and HDL
Timepoint
Autoanalyzer and Westergren Method
Method of measurement
Autoanalyzer

Intervention groups

1

Description
Intervention group: The patients in the intervention group will receive the Nutrition Bio-Shield (NBS) powder in addition to the standard treatment panel as follows: The daily dose of NBS is 4.5 grams, taken in three 1.5-gram doses—1.5 grams in the morning, 1.5 grams at noon, and 1.5 grams at night—for a duration of 6 months.
Category
Treatment - Drugs

2

Description
Control group: The patients in the control group will receive a placebo in addition to the standard treatment regimen, with the placebo administered in the morning, noon, and night.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Mehrdad Mosadegh
Street address
Imam Khomeini Hospital Complex, End of Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0100
Fax
+98 21 6658 1625
Email
Imamhospital@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research, Mazandaran University of Medical Sciences
Street address
Ramsar, Enghelab Square, Sakht Sar Street, Sakht Sar 3, Opposite the Department of Education.
City
Ramsar
Province
Mazandaran
Postal code
4691710001
Phone
+98 935 563 3390
Email
ramsar.int.co@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Tehran University of Medical Sciences
Full name of responsible person
Mehrdad Mosadegh
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Tehran University of Medical Sciences, Poursina St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 935 563 3390
Fax
Email
m-mosadegh@alumnus.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrdad Mosadegh
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Tehran University of Medical Sciences, Poursina St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 935 563 3390
Fax
Email
m-mosadegh@alumnus.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrdad Mosadegh
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Tehran University of Medical Sciences, Poursina St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 935 563 3390
Fax
Email
m-mosadegh@alumnus.tums.ac.ir

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
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