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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070770
• Other study ID #: LHS2014
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: November 2020
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Very low calorie diet

Other:
• Standard weight loss diet

Locations

Country	Name	City	State
United Kingdom	Diabetes & Nutritional Sciences Division, King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Lighterlife Ltd (UK)

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 Diet

Outcome

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

External Links

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