We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02070770
First Posted: February 25, 2014
Last Update Posted: May 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Lighterlife Ltd (UK)
Information provided by (Responsible Party):
Dr Wendy Hall, King's College London
  Purpose
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 Intervention
Obesity Dietary Supplement: Very low calorie diet Other: Standard weight loss diet

Study Type: Interventional
Study Design: 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

Further study details as provided by Dr Wendy Hall, King's College London:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
  • 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 ]
  • Change from baseline in 24 h mean IBI (interbeat interval) at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in night-time mean IBI (interbeat interval) at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in daytime mean IBI (interbeat interval) at day 7 [ Time Frame: Baseline, day 7 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change from baseline in 24 h triangular index at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in night-time triangular index at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in daytime triangular index at day 7 [ Time Frame: Baseline, day 7 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change from baseline in 24 h LF (low frequency power) at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in night-time LF (low frequency power) at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in daytime LF (low frequency power) at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in 24 h HF (high frequency power) at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in night-time HF (high frequency power) at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in daytime HF (high frequency power) at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in 24 h LF/HF at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in night-time LF/HF at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in daytime LF/HF at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in 24 h VLF (very low frequency power) at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in night-time VLF (very low frequency power) at day 7 [ Time Frame: Baseline, day 7 ]
  • Change from baseline in daytime VLF (very low frequency power) at day 7 [ Time Frame: Baseline, day 7 ]

Enrollment: 31
Study Start Date: May 2014
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Very low calorie diet Dietary Supplement: Very low calorie diet
Other Name: Lighterlife Total
Active Comparator: Standard weight loss diet Other: Standard weight loss diet

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   32 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070770


Locations
United Kingdom
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
  More Information

Responsible Party: Dr Wendy Hall, Lecturer in Nutritional Sciences, King's College London
ClinicalTrials.gov Identifier: NCT02070770     History of Changes
Other Study ID Numbers: LHS2014
First Submitted: February 23, 2014
First Posted: February 25, 2014
Last Update Posted: May 21, 2015
Last Verified: May 2015