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

NCT02070770 | Completed

• 1 other identifier: LHS2014
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Baseline, day 7

• Change from baseline in daytime SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7

  Baseline, day 7

• Change from baseline in 24 h mean IBI (interbeat interval) at day 7

  Baseline, day 7

• Change from baseline in night-time mean IBI (interbeat interval) at day 7

  Baseline, day 7

• Change from baseline in daytime mean IBI (interbeat interval) at day 7

  Baseline, day 7

Study Arms (2)

Very low calorie diet

EXPERIMENTAL

Dietary Supplement: Very low calorie diet

Standard weight loss diet

ACTIVE COMPARATOR

Other: Standard weight loss diet

Interventions

Very low calorie diet DIETARY_SUPPLEMENT

Also known as: Lighterlife Total

Very low calorie diet

Standard weight loss diet OTHER

Standard weight loss diet

Eligibility Criteria

• Age: 32 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, non-smoking men and women
• Aged 32-65 years
• BMI 30-42 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Lighterlife Ltd (UK): collaborator

Study Sites (1)

Diabetes & Nutritional Sciences Division, King's College London

London, SE1 9NH, United Kingdom

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wendy L Hall, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Nutritional Sciences

Study Record Dates

• First Submitted: February 23, 2014
• First Posted: February 25, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)