Effect of nutraceuticals on fat oxidation and energy expenditure among Indian adult males

Completed

Conditions: Age- 18-30 yearsBody fat %- 10% - 30% Subjects being stable weight for last 3 monthsSubjects with normal renal and liver function

Registration Number: CTRI/2018/02/012007

Lead Sponsor: St Johns Research Institute

Brief Summary: Theprevalence of overweight and obesity is rapidly increasing worldwide and even alow to middle income country like India has succumbed to this. There aremultiple etiologies to excess accumulation of fat, among all, positive energybalance due to excess energy intake or reduced physical activity and bodyâ€™sinability to oxidize fat based on its availability and demand, also known asmetabolic inflexibility, tends to be the leading risk factors. The presentstudy was aimed to first measure the intra- and inter-individual variability innocturnal fat oxidation among young male adults. And second was to examine theeffects 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.

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

Theintra- and inter-individual variability in nocturnal fat oxidation was lowerwith 3-day dietary adaptation compared to 1-day dietary adaptation. The intra-inter-individual variability in nocturnal fat oxidation with 3-day dietaryadaptation was 4.7% and 7.2%, respectively. The metabolic flexibility to fatoxidation was found to be lower in individuals with high BMI as assessed by theinverse correlation for either âˆ†RQ or Fed:Fasted RQ with fat oxidation. Amongall four dietary bioactive compounds, only caffeine showed promising resultswith a significant increase in nocturnal EE compared to placebo (+0.2 KJ/min).For nocturnal fat oxidation too, caffeine showed 10% significant increase innocturnal fat oxidation compared to placebo. Therefore, the increase in EE andfat oxidation and thereby, metabolic flexibility, can be achieved by consumingcaffeine, as an adjunct therapy along with dietary and physical activitymodifications. However, these findings will need to be confirmed further withlarger sample size and across sex and age groups. The use of other dietarybioactive compounds (EGCG, capsaicin and cinnamaldehyde) for the same requiresfurther investigation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 10

Inclusion Criteria

Healthy Indian male volunteers aged 18-30 years 2.
BMI between 18.5-29.9 Kg/mÂ² 3.
Normal renal and liver function tests 4.
Subjects willing to give informed consent 5.
Subjects being stable weight for last 3 months.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): St. Johns Medical College and Hospital
🇮🇳
Bangalore, KARNATAKA, India
St. Johns Medical College and Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Rebecca Raj
Principal investigator
9886002210
rebecca@sjri.res.in