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

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT02070770
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-23
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-25
• Study Start: 2014-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from baseline in 24 h 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 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 SDNN (mean of the standard deviations of the normal-to-normal intervals) 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 night-time SDNN (mean of the standard deviations of the normal-to-normal intervals) 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 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 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 LF (low frequency power) 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 RMSSD (root mean square of successive differences of normal-to-normal differences) 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 LF/HF 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 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 daytime HF (high frequency power) 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 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 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

Trial Locations

Locations (1)

Diabetes & Nutritional Sciences Division, King's College London; 🇬🇧 London, United Kingdom