The Effect of a Short-term Very Low Calorie Diet on Heart Rate Variability in Obese Individuals

The Effect of Short-term Adherence to a Very Low Calorie Diet on Heart Rate Variability: a Pilot Randomised Controlled Trial in Obese Men and Women

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02070770

Enrollment

Registered

2014-02-25

Start date

2014-05-31

Completion date

2015-05-31

Last updated

2020-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

The purpose of this study is to determine whether short-term adherence to a very low calorie diet is effective in improving heart rate variability in obese individuals.

Interventions

DIETARY_SUPPLEMENTVery low calorie diet

OTHERStandard weight loss diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

32 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy, non-smoking men and women * Aged 32-65 years * BMI 30-42 kg/m2

Exclusion criteria

* History of cardiovascular disease, diabetes, cancer, renal or liver disease or chronic gastrointestinal disorder * Epileptic or history of fainting * Adhered to a VLCD in the past 6 months * History of drug or alcohol abuse including heavy drinking. * Pregnancy, planning to get pregnant or breastfeeding * Currently taking medications to control blood pressure * Weight change of over 3kg in the past two months

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in 24 h SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7	Baseline, day 7	SDNN is a time domain parameter of overall heart rate variability

Secondary

Measure	Time frame
Change from baseline in night-time triangular index at day 7	Baseline, day 7
Change from baseline in daytime triangular index at day 7	Baseline, day 7
Change from baseline in night-time SDANN (standard deviations of the average normal-to-normal intervals calculated over periods of 5-minutes) at day 7	Baseline, day 7
Change from baseline in daytime SDANN (standard deviations of the average normal-to-normal intervals calculated over periods of 5-minutes) at day 7	Baseline, day 7
Change from baseline in night-time SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7	Baseline, day 7
Change from baseline in daytime SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7	Baseline, day 7
Change from baseline in 24 h mean IBI (interbeat interval) at day 7	Baseline, day 7
Change from baseline in night-time mean IBI (interbeat interval) at day 7	Baseline, day 7
Change from baseline in daytime mean IBI (interbeat interval) at day 7	Baseline, day 7
Change from baseline in 24 h SDANN (standard deviations of the average normal-to-normal intervals calculated over periods of 5-minutes) at day 7	Baseline, day 7
Change from baseline in 24 h triangular index at day 7	Baseline, day 7
Change from baseline in 24 h RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7	Baseline, day 7
Change from baseline in night-time RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7	Baseline, day 7
Change from baseline in daytime RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7	Baseline, day 7
Change from baseline in 24 h pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7	Baseline, day 7
Change from baseline in night-time pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7	Baseline, day 7
Change from baseline in daytime pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7	Baseline, day 7
Change from baseline in 24 h LF (low frequency power) at day 7	Baseline, day 7
Change from baseline in night-time LF (low frequency power) at day 7	Baseline, day 7
Change from baseline in daytime LF (low frequency power) at day 7	Baseline, day 7
Change from baseline in 24 h HF (high frequency power) at day 7	Baseline, day 7
Change from baseline in night-time HF (high frequency power) at day 7	Baseline, day 7
Change from baseline in daytime HF (high frequency power) at day 7	Baseline, day 7
Change from baseline in 24 h LF/HF at day 7	Baseline, day 7
Change from baseline in night-time LF/HF at day 7	Baseline, day 7
Change from baseline in daytime LF/HF at day 7	Baseline, day 7
Change from baseline in 24 h VLF (very low frequency power) at day 7	Baseline, day 7
Change from baseline in night-time VLF (very low frequency power) at day 7	Baseline, day 7
Change from baseline in daytime VLF (very low frequency power) at day 7	Baseline, day 7

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026