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Completed

NCT Number: NCT02070770

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

32 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes & Nutritional Sciences Division, King's College London

London, SE1 9NH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Very Low Calorie Diet

Dietary Supplement

Other names: Lighterlife Total

Standard weight loss diet

Other

Primary outcomes

  1. Change from baseline in 24 h SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7

    Time frame: Baseline, day 7

    SDNN is a time domain parameter of overall heart rate variability

Secondary outcomes

  1. Change from baseline in night-time SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7

    Time frame: Baseline, day 7

  2. Change from baseline in daytime SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7

    Time frame: Baseline, day 7

  3. Change from baseline in 24 h mean IBI (interbeat interval) at day 7

    Time frame: Baseline, day 7

  4. Change from baseline in night-time mean IBI (interbeat interval) at day 7

    Time frame: Baseline, day 7

  5. Change from baseline in daytime mean IBI (interbeat interval) at day 7

    Time frame: Baseline, day 7

  6. 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

    Time frame: Baseline, day 7

  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

    Time frame: Baseline, day 7

  8. Change from baseline in daytime SDANN (standard deviations of the average normal-to-normal intervals calculated over periods of 5-minutes) at day 7

    Time frame: Baseline, day 7

  9. Change from baseline in 24 h triangular index at day 7

    Time frame: Baseline, day 7

  10. Change from baseline in night-time triangular index at day 7

    Time frame: Baseline, day 7

  11. Change from baseline in daytime triangular index at day 7

    Time frame: Baseline, day 7

  12. Change from baseline in 24 h RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7

    Time frame: Baseline, day 7

  13. Change from baseline in night-time RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7

    Time frame: Baseline, day 7

  14. Change from baseline in daytime RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7

    Time frame: Baseline, day 7

  15. Change from baseline in 24 h pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7

    Time frame: Baseline, day 7

  16. Change from baseline in night-time pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7

    Time frame: Baseline, day 7

  17. Change from baseline in daytime pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7

    Time frame: Baseline, day 7

  18. Change from baseline in 24 h LF (low frequency power) at day 7

    Time frame: Baseline, day 7

  19. Change from baseline in night-time LF (low frequency power) at day 7

    Time frame: Baseline, day 7

  20. Change from baseline in daytime LF (low frequency power) at day 7

    Time frame: Baseline, day 7

  21. Change from baseline in 24 h HF (high frequency power) at day 7

    Time frame: Baseline, day 7

  22. Change from baseline in night-time HF (high frequency power) at day 7

    Time frame: Baseline, day 7

  23. Change from baseline in daytime HF (high frequency power) at day 7

    Time frame: Baseline, day 7

  24. Change from baseline in 24 h LF/HF at day 7

    Time frame: Baseline, day 7

  25. Change from baseline in night-time LF/HF at day 7

    Time frame: Baseline, day 7

  26. Change from baseline in daytime LF/HF at day 7

    Time frame: Baseline, day 7

  27. Change from baseline in 24 h VLF (very low frequency power) at day 7

    Time frame: Baseline, day 7

  28. Change from baseline in night-time VLF (very low frequency power) at day 7

    Time frame: Baseline, day 7

  29. Change from baseline in daytime VLF (very low frequency power) at day 7

    Time frame: Baseline, day 7

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Lighterlife Ltd (UK)

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 25, 2014
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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