CClinicalTrials.gg
CompletedNCT02070770Updated Nov 6, 2020

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

An interventional study of Very low calorie diet and Standard weight loss diet in Obesity, sponsored by King's College London. Completed at 1 site in United Kingdom. Open to participants aged 32 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-06.

Sponsored by King's College London · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
32 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
03

In context

Lead sponsor

King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
32 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy, non-smoking men and women
  • Aged 32-65 years
  • BMI 30-42 kg/m2

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Very low calorie diet

    Dietary Supplement: Very low calorie diet

  • Active comparator
    Standard weight loss diet

    Other: Standard weight loss diet

Interventions

  • Dietary supplementVery low calorie diet

    Also known as: Lighterlife Total

  • OtherStandard weight loss diet
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, day 7

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

07

Study locations

1 site
  • Diabetes & Nutritional Sciences Division, King's College London
    London, SE1 9NH, United Kingdom
08

References and documents

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.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02070770
Lead sponsor
King's College London
Collaborators
Lighterlife Ltd (UK)
Responsible party
Dr Wendy Hall (Lecturer in Nutritional Sciences, King's College London) — Principal investigator
First posted
Feb 25, 2014
Start date
May 2014
Primary completion
May 2015
Completion
May 2015
Last update
Nov 6, 2020

Study contacts

Wendy L Hall, PhD
principal investigator · King's College London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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