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

NCT ID: NCT02070770

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Very low calorie diet

Group Type EXPERIMENTAL

Very low calorie diet

Intervention Type DIETARY_SUPPLEMENT

Standard weight loss diet

Group Type ACTIVE_COMPARATOR

Standard weight loss diet

Intervention Type OTHER

Interventions

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Very low calorie diet

Intervention Type DIETARY_SUPPLEMENT

Standard weight loss diet

Intervention Type OTHER

Other Intervention Names

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Lighterlife Total

Eligibility Criteria

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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
Minimum Eligible Age

32 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lighterlife Ltd (UK)

UNKNOWN

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Dr Wendy Hall

Lecturer in Nutritional Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wendy L Hall, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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Diabetes & Nutritional Sciences Division, King's College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT

Other Identifiers

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LHS2014

Identifier Type: -

Identifier Source: org_study_id