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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Very low calorie diet; Other: Standard weight loss diet

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9NH
    • Diabetes & Nutritional Sciences Division, King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 32 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Very low calorie diet	Dietary supplement: Very low calorie diet; Other Names: Lighterlife Total
Active Comparator: Standard weight loss diet	Other: Standard weight loss diet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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 24 h triangular index 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 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

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Lighterlife Ltd (UK)

Publications and helpful links

General Publications

• F Fitzpatrick, A White, R Allen, A Pinto & W Hall. Short-term adherence to a very low calorie diet increases heart rate variability and reduces 24 hours heart rate in obese subjects: a randomised controlled pilot study. Journal of Human Nutrition and Dietetics. 2016; 29 (Suppl. 1), 45-46, AB47.

Helpful Links

• Special Issue:Abstracts from the 2015 BDA Research Symposium, 2 December 2015, Birmingham, UK

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 23, 2014
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (Estimate): February 25, 2014

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: LHS2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No