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

King's College London

Status: Completed

Conditions: Obesity

Treatments: Other: Standard weight loss diet; Dietary Supplement: Very low calorie diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02070770

LHS2014

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 32 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Very low calorie diet

Experimental group

Treatment:

Dietary Supplement: Very low calorie diet

Standard weight loss diet

Active Comparator group

Treatment:

Other: Standard weight loss diet