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CTRI Number  CTRI/2018/02/012007 [Registered on: 20/02/2018] Trial Registered Retrospectively
Last Modified On: 08/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effect of nutraceuticals on fat oxidation and energy expenditure among Indian adult males 
Scientific Title of Study   Effect of dietary bioactive compounds on fat oxidation and thermogenesis among healthy Indian adult male subjects using whole body indirect calorimetry 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
59/1/06042017  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rebecca Raj 
Designation  Associate Professor 
Affiliation  St Johns Research Institute 
Address  Division of Nutrition, St Johns Research Institute, 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka
Division of Nutrition, St Johns Research Institute, 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka
Bangalore
KARNATAKA
560034
India 
Phone  9886002210  
Fax    
Email  rebecca@sjri.res.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rebecca Raj 
Designation  Associate Professor 
Affiliation  St Johns Research Institute 
Address  Division of Nutrition, St Johns Research Institute, 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka
Division of Nutrition, St Johns Research Institute, 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka
Bangalore
KARNATAKA
560034
India 
Phone  9886002210  
Fax    
Email  rebecca@sjri.res.in  
 
Details of Contact Person
Public Query
 
Name  Ms Srishti Sinha 
Designation  PhD Student 
Affiliation  St Johns Research Institute 
Address  Division of Nutrition, St Johns Research Institute, 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka
Division of Nutrition, St Johns Research Institute, 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka
Bangalore
KARNATAKA
560034
India 
Phone  9971312145  
Fax    
Email  srishti.s@sjri.res.in  
 
Source of Monetary or Material Support  
Intramural Funding, Department of Physiology, Division of Nutrition, St. Johns Medical College, St. Johns Research Institute, John Nagar, Sarjapur Road, Bangalore, India-560034  
 
Primary Sponsor  
Name  St Johns Research Institute 
Address  Division of Nutrition St. John’s Medical College & St. John’s Research Institute. Bangalore – 560034 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rebecca Raj  St. Johns Medical College and Hospital  Department of Physiology, 3rd floor, Clinical Research Center, Room no.: 403
Bangalore
KARNATAKA 
9886002210

rebecca@sjri.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Age- 18-30 years Body fat %- 10% - 30% Subjects being stable weight for last 3 months Subjects with normal renal and liver function  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Epigallocatechin -3- gallete 2. Caffeine 3. Capsaicin 4. Cinnamaldehyde  Dose of dietary bioactive compounds - 1. Epigallocatechin-3- gallate from green tea- 300mg 2. Caffeine from green tea - 200 mg 3. Capsaicin from red pepper- 7.5mg 4. Cinnamaldehyde from cinnamon - 70mg Route of administration - Oral Total duration of therapy - The dietary bioactive compound will be provided once after dinner. Since it is a cross-over study, subjects will receive all the intervention once with wash out of minimum 3 days. 
Comparator Agent  Cellulose powder  This will be Placebo given once in the cross-over study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Male 
Details  1. Healthy Indian male volunteers aged 18-30 years
2. BMI between 18.5-29.9 Kg/m²
3. Normal renal and liver function tests
4. Subjects willing to give informed consent
5. Subjects being stable weight for last 3 months
 
 
ExclusionCriteria 
Details  1. Subjects with hypertension, diabetes
2. History of chronic cigarette smoking or any form of addictions
3. Subjects using anorectic or related compounds
4. History of allergic rhinitis, nasal block
5. Subjects on any long term medications especially bronchodilators, thyroxin
6. Subject consuming caffeine >200mg/day (more than 4 cups coffee per day)
7. Subjects consuming alcohol >120ml on regular basis/ consumed within 48 hrs of the study
8. Those who have physical activity level (PAL) > 1.5 for the past 48 hrs
9. Subjects consumed alcohol and caffeine 24 hour prior to the experiment 
 
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 
To assess the effect of epigallocatechin-3-gallete (EGCG), caffeine, capsaicin and cinnamaldehyde on EE (REE, DIT and SEE) and nocturnal fat oxidation among normal weight and overweight/obese young (18-30 years) healthy Indian males.   The nocturnal fat oxidation and energy expenditure will be assessed after supplementing for one day. The outcome will be measured on five nights with a wash out of minimum 3 days. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the intra-individual variability in nocturnal fat oxidation among normal and overweight/obese subjects.
2. To investigate the effect of purified extracts of mentioned bioactive compounds on heart rate variability, blood pressure and body temperature
3. To examine the associations of EE and fat oxidation with body composition, insulin sensitivity, habitual physical activity pattern, sleeping pattern and nutrient intake  
1. Heart rate variability, blood pressure and body temperature - 5 time points in each experiment
2. Body composition, glucose tolerance and insulin sensitivity- 1 time point for each subject
3. Habitual physical activity pattern, sleeping pattern, nutrient intake and habitual consumption of the bioactive compounds- 1 time point for each subject 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "9"
Final Enrollment numbers achieved (India)="9" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2017 
Date of Study Completion (India) 18/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Date of publication – 08 September, 2021 Citation – Sinha S, Kuriyan R. Nocturnal Fat Oxidation and Metabolic Flexibility of Young Male Indian Adults Using Indirect Calorimetry. The Indian Journal of Nutrition and Dietetics. 2021;58(3):339-49. Link – 10.21048/IJND.2021.58.3.27554  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The prevalence of overweight and obesity is rapidly increasing worldwide and even a low to middle income country like India has succumbed to this. There are multiple etiologies to excess accumulation of fat, among all, positive energy balance due to excess energy intake or reduced physical activity and body’s inability to oxidize fat based on its availability and demand, also known as metabolic inflexibility, tends to be the leading risk factors. The present study was aimed to first measure the intra- and inter-individual variability in nocturnal fat oxidation among young male adults. And second was to examine the effects of four dietary bioactive compounds namely, epigallocatechin-3-gallete (EGCG), caffeine, capsaicin and cinnamaldehyde, on nocturnal energy expenditure (EE) and fat oxidation among young male adults.

The variability in nocturnal fat oxidation was measured using whole-body indirect calorimetry (WBIC). The participants were randomly assigned to receive two different durations of adaptation diet: 3-day (n=5) or 1-day (n=4) dietary adaptation group. Each participant was studied on two separate occasions carried out within 1-week to measure intra-individual variability in nocturnal fat oxidation. The data from all participants were used to calculate inter-individual variability in nocturnal fat oxidation. For the second part of the study, a double-blind, placebo-controlled, randomized controlled trial study design was followed. From a total 19 screened participants, only 9 enrolled for this part of the study. A single dose of the compounds was given to the participants and dose were as follows: EGCG at 300 mg, caffeine at 200 mg, capsaicin at 7.5 mg and cinnamaldehyde at 70 mg. The placebo contained equivalent amounts of bread crumbs. Each dose was weighed in a cellulose-based capsules by the third party to ensure blinding. Each participant was studied on five separate occasions after 3-days dietary adaptation with 1-week wash-out period and carried out within 5-6 weeks. The nocturnal EE and fat oxidation were compared between placebo and interventions.

The intra- and inter-individual variability in nocturnal fat oxidation was lower with 3-day dietary adaptation compared to 1-day dietary adaptation. The intra- inter-individual variability in nocturnal fat oxidation with 3-day dietary adaptation was 4.7% and 7.2%, respectively. The metabolic flexibility to fat oxidation was found to be lower in individuals with high BMI as assessed by the inverse correlation for either ∆RQ or Fed:Fasted RQ with fat oxidation. Among all four dietary bioactive compounds, only caffeine showed promising results with a significant increase in nocturnal EE compared to placebo (+0.2 KJ/min). For nocturnal fat oxidation too, caffeine showed 10% significant increase in nocturnal fat oxidation compared to placebo. Therefore, the increase in EE and fat oxidation and thereby, metabolic flexibility, can be achieved by consuming caffeine, as an adjunct therapy along with dietary and physical activity modifications. However, these findings will need to be confirmed further with larger sample size and across sex and age groups. The use of other dietary bioactive compounds (EGCG, capsaicin and cinnamaldehyde) for the same requires further investigation.

 
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