IRCT | 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.

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

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

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.