None listed
Conditions
Brief summary
For many years health professionals have recommended ‘slow and steady’ weight loss. Recently however an increasing number of health professionals have begun prescribing very low energy diets (VLEDs) for the management of excess body weight. VLEDs can induce fast weight losses of approximately 0.5 to 2 kilos per week, which some people find motivating. Moreover, some people report not feeling hungry while on a VLED. While VLEDs are known to be safe and effective in the short-term, the long-term consequences are unknown. There is some concern that compared to slower weight loss, VLEDs may increase the likelihood of weight regain, particularly in the abdominal region, and this could increase the risk of cardiovascular disease. Additionally, VLEDs may cause greater losses of muscle mass, muscle strength and bone density compared to slower ‘conventional diets’, but this has never been tested. This study will demonstrate whether or not there are any differences between VLED and conventional diet with respect to effects on body fat content and distribution, muscle mass, muscle strength or bone density for up to 3 years after commencement of either diet.
Interventions
Two 12-month dietary interventions will be compared: very low energy diet (VLED) and conventional diet. The VLED is an approximately 2,100 kilojoule (500 calorie) per day diet consisting of meal replacement shakes, bars or desserts. No other foods will be consumed during the VLED except for low calorie jelly, strained broth and certain vegetables. The VLED will be used for a minimum of 3 months and a maximum of 5 months, after which time participants will switch to either a partial meal replacem
Two 12-month dietary interventions will be compared: very low energy diet (VLED) and conventional diet. The VLED is an approximately 2,100 kilojoule (500 calorie) per day diet consisting of meal replacement shakes, bars or desserts. No other foods will be consumed during the VLED except for low calorie jelly, strained broth and certain vegetables. The VLED will be used for a minimum of 3 months and a maximum of 5 months, after which time participants will switch to either a partial meal replacement program for further weight loss if required (~1,500 kcal per day), or the conventional diet for weight maintenance for the remainder of the 12 months. The conventional diet is a lifestyle weight management program consisting of moderate kilojoule restriction (~500 kcal deficit per day) and involves general recommendations for healthy eating such as increasing fruit and vegetable intake and reducing the intake of processed or fatty foods (e.g. cakes, chocolate, visible fat on meat, etc).
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Sedentary (< 60 minutes physical activity / week) * Class I or II obesity (30-40 kg.m2) * At least 5 years post-menopausal
Exclusion criteria
* Hypothyroidism or hyperthyroidism * Diabetes * Osteoporosis * Smoker * Non-ambulatory * Gained or lost more than 2 kg in the last 6 months * Taking medications known to affect heart rate, body composition or bone mass (e.g. glucocorticoids or beta blockers) * Have taken anti-resorptive therapy within the last 3 years * Alcohol or drug dependency * Presence of metal in the body (e.g. from a pacemaker)
Outcome results
None listed