Clinical trial NCT02070770: The Effect of a Short-term Very Low Calorie Diet on Heart Rate Variability in Obese Individuals
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Lighterlife Ltd (UK)
First posted: 2014-02-25
Enrollment: 31
Sex: ALL
Minimum age (years): 32
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in 24 h SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7
timeFrame: Baseline, day 7
Secondary outcomes:
measure: Change from baseline in night-time SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in daytime SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in 24 h mean IBI (interbeat interval) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in night-time mean IBI (interbeat interval) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in daytime mean IBI (interbeat interval) at day 7
timeFrame: Baseline, day 7
measure: 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
timeFrame: Baseline, day 7
measure: 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
timeFrame: Baseline, day 7
measure: Change from baseline in daytime SDANN (standard deviations of the average normal-to-normal intervals calculated over periods of 5-minutes) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in 24 h triangular index at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in night-time triangular index at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in daytime triangular index at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in 24 h RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in night-time RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in daytime RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in 24 h pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in night-time pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in daytime pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in 24 h LF (low frequency power) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in night-time LF (low frequency power) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in daytime LF (low frequency power) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in 24 h HF (high frequency power) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in night-time HF (high frequency power) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in daytime HF (high frequency power) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in 24 h LF/HF at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in night-time LF/HF at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in daytime LF/HF at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in 24 h VLF (very low frequency power) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in night-time VLF (very low frequency power) at day 7
timeFrame: Baseline, day 7
measure: Change from baseline in daytime VLF (very low frequency power) at day 7
timeFrame: Baseline, day 7
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Diabetes & Nutritional Sciences Division, King's College London
Study officials:
affiliation: King's College London
name: Wendy L Hall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.