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
|
|
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
|
|
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. |