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

Sponsor
King's College London (Other)
Overall Status
Completed
CT.gov ID
NCT02070770
Collaborator
Lighterlife Ltd (UK) (Other)
31
Enrollment
1
Location
2
Arms
12
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Very low calorie diet
  • Other: Standard weight loss diet
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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 Start Date :
May 1, 2014
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

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

      SDNN is a time domain parameter of overall heart rate variability

    Secondary Outcome Measures

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

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

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

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

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

    9. Change from baseline in 24 h triangular index at day 7 [Baseline, day 7]

    10. Change from baseline in night-time triangular index at day 7 [Baseline, day 7]

    11. Change from baseline in daytime triangular index at day 7 [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 [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 [Baseline, day 7]

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

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

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

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

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

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

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

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

    24. Change from baseline in 24 h LF/HF at day 7 [Baseline, day 7]

    25. Change from baseline in night-time LF/HF at day 7 [Baseline, day 7]

    26. Change from baseline in daytime LF/HF at day 7 [Baseline, day 7]

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

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    32 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Diabetes & Nutritional Sciences Division, King's College London London United Kingdom SE1 9NH

    Sponsors and Collaborators

    • King's College London
    • Lighterlife Ltd (UK)

    Investigators

    • Principal Investigator: Wendy L Hall, PhD, King's College London

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Dr Wendy Hall, Lecturer in Nutritional Sciences, King's College London
    ClinicalTrials.gov Identifier:
    NCT02070770
    Other Study ID Numbers:
    • LHS2014
    First Posted:
    Feb 25, 2014
    Last Update Posted:
    Nov 6, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 6, 2020