ObesityNCT02070770
The Effect of a Short-term Very Low Calorie Diet on Heart Rate Variability in Obese Individuals
A study testing Very low calorie diet and Standard weight loss diet in people with Obesity, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Very low calorie diet and Standard weight loss diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, non-smoking men and women
- Aged 32-65 years
- BMI 30-42 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes & Nutritional Sciences Division, King's College London
London, SE1 9NH
About this study
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
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.
- Conditions
- Obesity
- Being tested
- Very low calorie diet, Standard weight loss diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low calorie dietDietary supplement
Also called Lighterlife Total
Standard weight loss dietOther
| Study group | Role | What they receive |
|---|---|---|
| Very low calorie diet | Experimental | Not described Receives: Dietary Supplement: Very low calorie diet |
| Standard weight loss diet | Active comparator | Not described Receives: Other: Standard weight loss diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, day 7
Secondary outcomes (29)
Change from baseline in night-time SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7
Measured: Baseline, day 7
Change from baseline in daytime SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7
Measured: Baseline, day 7
Change from baseline in 24 h mean IBI (interbeat interval) at day 7
Measured: Baseline, day 7
Change from baseline in night-time mean IBI (interbeat interval) at day 7
Measured: Baseline, day 7
Change from baseline in daytime mean IBI (interbeat interval) at day 7
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, day 7
Change from baseline in 24 h triangular index at day 7
Measured: Baseline, day 7
Change from baseline in night-time triangular index at day 7
Measured: Baseline, day 7
Change from baseline in daytime triangular index at day 7
Measured: Baseline, day 7
Change from baseline in 24 h RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7
Measured: Baseline, day 7
Change from baseline in night-time RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7
Measured: Baseline, day 7
Change from baseline in daytime RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7
Measured: Baseline, day 7
Change from baseline in 24 h pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7
Measured: Baseline, day 7
Change from baseline in night-time pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7
Measured: Baseline, day 7
Change from baseline in daytime pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7
Measured: Baseline, day 7
Change from baseline in 24 h LF (low frequency power) at day 7
Measured: Baseline, day 7
Change from baseline in night-time LF (low frequency power) at day 7
Measured: Baseline, day 7
Change from baseline in daytime LF (low frequency power) at day 7
Measured: Baseline, day 7
Change from baseline in 24 h HF (high frequency power) at day 7
Measured: Baseline, day 7
Change from baseline in night-time HF (high frequency power) at day 7
Measured: Baseline, day 7
Change from baseline in daytime HF (high frequency power) at day 7
Measured: Baseline, day 7
Change from baseline in 24 h LF/HF at day 7
Measured: Baseline, day 7
Change from baseline in night-time LF/HF at day 7
Measured: Baseline, day 7
Change from baseline in daytime LF/HF at day 7
Measured: Baseline, day 7
Change from baseline in 24 h VLF (very low frequency power) at day 7
Measured: Baseline, day 7
Change from baseline in night-time VLF (very low frequency power) at day 7
Measured: Baseline, day 7
Change from baseline in daytime VLF (very low frequency power) at day 7
Measured: Baseline, day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Lighterlife Ltd (UK)
- Responsible party
- Principal investigator, Dr Wendy Hall, King's College London
- Investigators
- Wendy L Hall, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070770
- Sponsor's protocol ID
- LHS2014
- Status last verified
- Nov 2020
- First submitted
- 23 Feb 2014
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02070770
- Acronym / sponsor ID
- LHS2014
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Lighterlife Ltd (UK)
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very low calorie diet | Experimental | Dietary Supplement: Very low calorie diet |
| Standard weight loss diet | Active comparator | Other: Standard weight loss diet |
Who may qualify
- Ages
- 32 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy, non-smoking men and women
- Aged 32-65 years
- BMI 30-42 kg/m2
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very low calorie dietAlso: Lighterlife Total | Dietary supplement | Very low calorie diet |
| Standard weight loss diet | Other | Standard weight loss diet |
Primary outcome
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
29 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Results publicationF 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 dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy L Hall, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very low calorie diet and Standard weight loss diet in people with Obesity, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02070770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.