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The Effectiveness of the Herbal Supplement Nutrition Bio-Shield (NBS) Superfood in Controlling Type 2 Diabetes Mellitus

Protocol summary

Study aim
The Efficacy of the Herbal Supplement Nutrition Bio-Shield (NBS) Superfood in the Management of Type 2 Diabetes Mellitus
Design
A controlled clinical trial with parallel groups, double-blind, randomized, Phase 1-2, was conducted on 74 patients. Randomization was performed using the RAND function in Excel software.
Settings and conduct
Patients, researchers, nurses, and statisticians are unaware of the grouping of patients receiving NBS powder. This clinical trial will be conducted in specialized clinics in Tehran. The intervention group (37 patients) will receive the standard treatment prescribed by their attending physician, along with NBS powder for a period of six months. The control group (37 patients) will receive the same treatment regimen along with a placebo for six months. Demographic and laboratory parameters of the patients, both before and after the intervention, will be collected and recorded in their medical files. Finally, statistical methods will be used to analyze the significance of the results.
Participants/Inclusion and exclusion criteria
Patients over the age of 18, whose diagnosis of type 2 diabetes mellitus was confirmed by a specialist based on clinical symptoms and laboratory tests, were included. Conversely, patients with chronic inflammatory, hepatic, or renal diseases, as well as those undergoing insulin therapy or using any other antihyperglycemic drugs within the past three months, were considered primary exclusion criteria.
Intervention groups
The intervention group will receive 4.5 grams of NBS powder daily, administered in three doses of 1.5 grams each, for a duration of six months alongside the standard treatment. Similarly, the control group will follow the same standard treatment regimen as the intervention group but will receive a placebo instead of the NBS powder.
Main outcome variables
Blood glucose level; Hemoglobin A1C level; Blood lipid levels

General information

Reason for update
Acronym
NBS-T2D
IRCT registration information
IRCT registration number: IRCT20241218064090N1
Registration date: 2024-12-30, 1403/10/10
Registration timing: prospective

Last update: 2024-12-30, 1403/10/10
Update count: 0
Registration date
2024-12-30, 1403/10/10
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
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of the Herbal Supplement Nutrition Bio-Shield (NBS) Superfood in Controlling Type 2 Diabetes Mellitus
Public title
Effects of NBS on Diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≥ 18 years BMI ≥ 25 kg/m² Glycated Hemoglobin (HbA1c) ≥ 6.5% Fasting Blood Glucose Levels ≥ 126 mg/dL Treated with Metformin prior to enrollment in the study
Exclusion criteria:
Withdrawal from the study by the participant. Presence of inflammatory diseases. Chronic kidney or liver diseases (Chronic Kidney Disease (CKD) defined as kidney damage or an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m² persisting for ≥ 3 months, leading to gradual loss of kidney function and often requiring renal replacement therapy such as dialysis or kidney transplantation. Acute liver failure is defined as severe acute liver injury lasting less than 26 weeks, accompanied by encephalopathy and INR ≥ 1.5 in the absence of prior cirrhosis or liver disease.) Patients undergoing hormone replacement therapy or taking antioxidant supplements. Patients treated with insulin. Patients unable to attend scheduled follow-up visits. Pregnant or lactating women. Drug hypersensitivity detected by the physician. Clinical deterioration due to NBS powder as determined by the physician. Diagnosis of Type 1 Diabetes. History of pancreatitis. Proliferative diabetic retinopathy or non-proliferative retinopathy requiring acute treatment. Proliferative Diabetic Retinopathy Diabetic maculopathy. Hepatitis. Gastroparesis. Estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/1.73 m² for patients on metformin. Use of any anti-hyperglycemic drugs within 3 months prior to screening. Use of lipid-lowering medications such as atorvastatin. Non-compliance with prescribed therapeutic and medication regimens. Occurrence of serious or unexpected adverse effects during the study. Emergence of new or widespread medical conditions that may impact study outcomes. Withdrawal from the study due to personal reasons or inability to continue participation. Transfer to other studies or initiation of alternative therapies requiring study discontinuation.
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to either the intervention or control group using a block randomization method. Sample allocation to the two groups will follow a permuted block randomization design with blocks of four. In this method, the letter A represents the intervention group, and the letter B represents the control group. Next, all possible permutations of the letters A and B within blocks of four, resulting in 6 different combinations, will be written on 6 separate cards as follows: AABB, ABBA, ABAB, BAAB, BABA, BBAA. Then, a random number between 1 and 6 will be selected to determine the sequence for group assignment. This process will be repeated until the required sample size is achieved.
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, Sakhtsar 3, Sakhtsar 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.1403.082

Health conditions studied

1

Description of health condition studied
Type 2 Diabetes Mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Blood Glucose Levels
Timepoint
Before the Intervention and 6 Months After the Intervention
Method of measurement
Autoanalyzer

2

Description
Hemoglobin A1C Levels
Timepoint
Before the Intervention and 6 Months After the Intervention
Method of measurement
Enzymatic Assay

Secondary outcomes

1

Description
Lipid Profile, Including Total Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglyceride
Timepoint
Before the Intervention and 6 Months After the Intervention.
Method of measurement
Autoanalyzer

2

Description
Creatinine and Blood Urea Nitrogen Levels
Timepoint
Before the Intervention and 6 Months After the Intervention.
Method of measurement
Autoanalyzer

3

Description
Insulin resistance factors, HOMA-IR and HOMA-DR
Timepoint
Before the Intervention and 6 Months After the Intervention.
Method of measurement
ELISA kit

Intervention groups

1

Description
Intervention group: The intervention involves the consumption of the NBS dietary supplement along with continuous oral support to address nutritional challenges for a duration of 6 months. The herbal supplement NBS is administered to the intervention group at a dosage of 4.5 grams daily, divided into three doses of 1.5 grams each, taken at 8-hour intervals.
Category
Treatment - Drugs

2

Description
Control group: Patients in the control group, in addition to the standard therapeutic regimen similar to the intervention group, receive a placebo administered in three doses at 8-hour intervals. To ensure the accuracy and reliability of the results in this clinical trial, the placebo is carefully designed and produced to be identical in appearance, texture, taste, and odor to the NBS supplement powder. The placebo is made from inert and safe substances, such as wheat flour, which have no distinct therapeutic effects. Furthermore, to prevent identification of the placebo by participants or researchers, sensory characteristics, including color, odor, and taste, are meticulously matched.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized Clinics in Tehran
Full name of responsible person
Mehrdad Mosadegh
Street address
Tehran University of Medical Sciences, Qods St., Tehran
City
Tehran
Province
Tehran
Postal code
1936893813
Phone
+98 935 563 3390
Email
m-mosadegh@alumnus.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Farbod Rahimi
Street address
Opposite the Department of Education, Sakhtsar 3, Sakhtsar Street, Enghelab Square, Ramsar
City
Ramsar
Province
Mazandaran
Postal code
4691710001
Phone
+98 11 5509 1101
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
1936893813
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
1936893813
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
1936893813
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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