| CTRI Number |
CTRI/2022/10/046112 [Registered on: 03/10/2022] Trial Registered Prospectively |
| Last Modified On: |
24/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of novel blended diet (BE22001) compared with conventional diet in improving the well-being of healthy adults |
|
Scientific Title of Study
|
A randomized, double-blind clinical study to evaluate the efficacy of a novel blended diet (BE22001) compared with a conventional diet in improving the well-being of healthy adults |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| B2E/BD/BE22001/22 Version 01, Dated 25-Jun-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Vidyardhi Nimmagadda |
| Designation |
Overall Trial Coordinator |
| Affiliation |
B2E Foods Private Limited |
| Address |
40-15-14, Sudarsan Apartment,
Brindavan colony, Tikkle road,
Labbipet, Vijayawada.
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
9059788223 |
| Fax |
|
| Email |
project@icurry.co |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tirupathi Rao |
| Designation |
Research Executive |
| Affiliation |
B2E Foods Private Limited |
| Address |
Unit 11, Phase III, Jawahar Atonagar
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
9347539757 |
| Fax |
|
| Email |
clinical@icurry.co |
|
Details of Contact Person
Public Query
|
| Name |
Mr Vidyardhi Nimmagadda |
| Designation |
Project Manager |
| Affiliation |
B2E Foods Private Limited |
| Address |
40-15-14, Sudarsan Apartment,
Brindavan colony, Tikkle road,
Labbipet, Vijayawada.
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
9059788223 |
| Fax |
|
| Email |
project@icurry.co |
|
|
Source of Monetary or Material Support
|
| B2E Foods Private Limited Internal funding |
|
|
Primary Sponsor
|
| Name |
B2E Foods Private Limited |
| Address |
40-15-14, Sudarsan Apartment, Brindavan colony, Tikkle road, Labbipet, Vijayawada, Krishna district, Andhra Pradesh-520010.
|
| Type of Sponsor |
Other [Food research ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G Ramesh |
Anu Hospitals |
Kovelamudivari Street, Suryaraopet, Vijayawada-520002
Krishna
ANDHRA PRADESH |
9246195564
0866-2434855
drctresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Anu Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Subjects |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:BE22001, Apathya:Nil | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Conventional Diet, Apathya:Nil |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy male and female subjects aged between 35-60 years with a Body Mass Index-BMI of 25-29.9 kg per metre square.
2.Subject agrees to consume provided vegetarian diet for four months approximately 1800 k.cal per day for Women and 2000 k.cal per day for Men as per dietician.
3.Subjects who agree to consume 3 meal patterns per day-breakfast, lunch and dinner for entire study duration.
4.Subject agrees not to fast during the study period.
5.Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and or bilateral oophorectomy.
6.Subject agrees not to use supplements, herbals, vitamins, any therapies that affect the study outcomes during the entire course of study.
7.Willing to sign written informed consent and comply with study protocol.
|
|
| ExclusionCriteria |
| Details |
1.Subjects underwent treatment for COVID-19 within last three months or tested positive during the study will be excluded.
2.Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, pagets disease, joint fracture, acromegaly, fibromyalgia, Wilsons disease, ochronosis, hemochromatosis, heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis.
3.Subjects having history of asthma and cardiovascular diseases.
4.Subjects who use any medicines or supplements for diabetic and or hypertension or hyperlipidemia.
5.Subjects having history of thyroid disease and coagulopathies.
6.Subjects having any significant findings in the laboratory test during screening as per PI discretion.
7.Subjects with HIV Positive.
8.Subjects having history of high alcohol intake greater than 2 standard drinks per day.
9.Females who are pregnant, breast feeding or planning to become pregnant during the study.
10.Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
11.Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures.
12.Subjects with known allergy to any of the dietary ingredients.
13.Subjects participated in any investigational study 30 days prior to screening.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change from baseline to the end of the study period in:
Triglyceride-Glucose Index (TyG Index)
|
Day 1, Day 30, Day 70 and Day 120
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline to the end of the study period in:
Atherogenic index of plasma (AIP)
|
Day 1, Day 30, Day 70 and Day 120 |
Change from baseline to the end of the study period in:
Lipid Profile
|
Day 1, Day 30, Day 70 and Day 120 |
Change from baseline to the end of the study period in:
Body weight
|
Day 1, Day 30, Day 70 and Day 120
|
Change from baseline to the end of the study period in:
Blood pressure
|
Day 1, Day 30, Day 70 and Day 120
|
Change from baseline to the end of the study period in:
Vitamin (B12 & D3) & Mineral (Ca, Mg, K, Cl & Fe) Test
|
Day 1 and Day 120
|
Change from baseline to the end of the study period in:
HOMA-IR |
Day 1, Day 30, Day 70 and Day 120 |
Change from baseline to the end of the study period in:
Subjective ratings of satiety, fullness, prospective food consumption, desire to eat something fatty, savoury (using 100 mm visual analogue scale) |
Day 1, Day 30, Day 70 and Day 120 |
Change from baseline to the end of the study period in:
Appetite hunger and sensory perception questionnaire (AHSP) |
Day 1, Day 30, Day 70 and Day 120 |
Change from baseline to the end of the study period in:
Bluestone mouth feel questionnaire (BMQ) |
Day 1, Day 30, Day 70 and Day 120 |
Change from baseline to the end of the study period in:
Gut related questionnaire (abdominal condition, sensation after defecation and tension of the lower abdomen using 10 cm visual analogue scale) |
Day 1, Day 30, Day 70 and Day 120 |
Change from baseline to the end of the study period in:
Sleep questionnaire (Athens Insomnia Scale-AIS) |
Day 1, Day 30, Day 70 and Day 120 |
Change from baseline to the end of the study period in:
Memory questionnaire (Mini-Cog©) |
Day 1, Day 30, Day 70 and Day 120
|
Change from baseline to the end of the study period in:
Handgrip strength (using digital hand dynamometer) |
Day 1 and Day 120 |
Change from baseline to the end of the study period in:
Six-minute walk test (6MWT) |
Day 1, Day 30, Day 70 and Day 120 |
Change from baseline to the end of the study period in:
Quality of life questionnaire (SF-36) |
Day 1, Day 30, Day 70 and Day 120 |
Change from baseline to the end of the study period in:
Subject’s self-assessment of skin questionnaire |
Day 1, Day 30, Day 70 and Day 120 |
Change from baseline to the end of the study period in:
Biomarkers (MDA, Antioxidant capacity & Oxidized LDL {Ox-LDL}) |
Day 1 and Day 120 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2022 |
| Date of Study Completion (India) |
15/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to assess efficacy of a novel blended diet (BE22001) compared with a conventional diet in healthy adults. A total of 40 male and female subjects of age between 35 and 60 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer generated randomization list. The subjects will be assigned to either one of the two study groups (Novel blend diet (BE22001) or Conventional diet) at 1:1 ratio. The participants will be instructed to take 1800-2000 kcal per day divided in 3 meals (breakfast-lunch-dinner) for women and men respectively for 120 days. The outcome measures include Triglyceride-Glucose Index (TyG Index), Atherogenic index of plasma (AIP), Lipid Profile, Body weight, Blood pressure, Vitamin (B12 & D3) & Mineral (Ca, Mg, K, Cl & Fe) Test, HOMA-IR, Subjective ratings of satiety, fullness, prospective food consumption, desire to eat something fatty, savoury (using 100 mm visual analogue scale), Appetite hunger and sensory perception questionnaire (AHSP), Bluestone mouth feel questionnaire (BMQ), Gut related questionnaire (abdominal condition, sensation after defecation and tension of the lower abdomen using 10 cm visual analogue scale), Sleep questionnaire (Athens Insomnia Scale-AIS), Memory questionnaire (Mini-Cog©) , Handgrip strength (using digital hand dynamometer), Six-minute walk test (6MWT), Quality of life questionnaire (SF-36), Subject’s self-assessment of skin questionnaire and Inflammatory Biomarkers (MDA, Antioxidant capacity & Oxidized LDL {Ox-LDL}) Besides, the study will also record the vital signs and adverse events to evaluate the safety and tolerability. The safety assessment of BE22001 will also include the routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention. |