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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Lighterlife Ltd (UK)
Information provided by (Responsible Party):
Dr Wendy Hall, King's College London
ClinicalTrials.gov Identifier:
NCT02070770
First received: February 23, 2014
Last updated: July 20, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ]

Estimated Enrollment: 70
Study Start Date: May 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 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

Ages Eligible for Study:   32 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 23, 2014
Last Updated: July 20, 2014
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on September 18, 2014