Comparison of varying dietary interventions in an obese population

ISRCTN	ISRCTN09760867
DOI	https://doi.org/10.1186/ISRCTN09760867
Protocol serial number	N/A
Sponsor	The Robert Gordon University (UK)
Funder	LighterLife UK Limited (UK)

Submission date: 05/09/2008
Registration date: 15/09/2008
Last edited: 27/01/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Iain Broom
Scientific

The Robert Gordon University
Centre for Obesity Research and Epidemiology
St. Andrew Street
Aberdeen
AB25 1HG
United Kingdom

Email	j.broom@rgu.ac.uk

Study information

Primary study design	Interventional
Study design	Single centre randomised clinical trial
Secondary study design	Randomised controlled trial
Scientific title	Randomised clinical trial of standard dietary treatment versus protein-sparing modified fast or the LighterLife Programme in the management of obesity
Study objectives	To assess the effectiveness of a low carbohydrate/high protein, a commercial very low calorie diet (LighterLife) and a 600-kcal deficient diet in an obese population.
Ethics approval(s)	Ethics approval received from the North of Scotland Research Ethics Service on the 3rd February 2005 (ref: 05/S0802/03).
Health condition(s) or problem(s) studied	Obesity
Intervention	Screening period: 600-kcal were subtracted from the subjects' estimated daily energy requirements. Portion sizes and food groups were explained to patients, who were also provided with written information. Patients were reviewed at 2, 4, 8 and 12 weeks. Randomisation: At the end of the screening period, patients who did not achieve a 5% weight loss were randomised to either protein-sparing modified fast (PSMF) or LighterLife (LL). PSMF patients were restricted to a maximum of 40 g of carbohydrate per day. Written information and examples of recipes were provided. The diet was supplemented with multivitamins and minerals. LighterLife is a commercial very-low calorie diet (VLCD) programme including group cognitive behaviour therapy (CBT). The programme consists of three stages: weight loss period of 100 days with VLCD provision and CBT; VLCD provision with continued counselling until target weight is achieved; 12-week weight management module with slow return to normal food and CBT. All participants were given additional lifestyle and dietary advice during 6 visits post randomisation. These interventions were evaulated over 1 year, and patients were then followed up for 2 years.
Intervention type	Other
Primary outcome measure(s)	Weight loss, measured in kilograms before screening, at screening and 3 and 9 months post-screening.
Key secondary outcome measure(s)	1. Changes in cardiovascular risk, measured by looking at total cholesterol, triacylglycerols, high density lipoprotein (HDL), low density lipoprotein (LDL), fasting glucose (all in mmol/L), fasting insulin (uU/ml), HbA1c (%) waist circumference (cm), blood pressure (mmHg) 2. Liver and kidney function; liver function assessed by measuring albumin (g/L), total bilirubin (umol/L), alkaline phosphatase, alanine aminotransferase and gamma-glutamyl transferase (U/L). For kidney function urea (mmol/L) and creatinine (umol/L) were measured and the estimated glomerular filtration was calculated. 3. Quality of life, measured using the following questionnaires: Physical activity (in house), the Dutch Eating Behaviour, the World Health Organization (WHO) quality of life, the Beck Depression Inventory, General Health, Lee fatigue scale and the Epworth Sleepiness Scale 4. Changes in adipokines All measured before screening, at screening and 3 and 9 months post-screening.
Completion date	30/11/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Men and women older than 18 years of age 2. Body Mass Index (BMI) greater than or equal to 35 kg/m^2
Key exclusion criteria	1. History of hepatic or renal disease 2. Cancer 3. Current pregnancy/lactating 4. On anti-depressants or anti-obesity medication 5. Eating disorders
Date of first enrolment	03/02/2005
Date of final enrolment	30/11/2009

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

The Robert Gordon University

Aberdeen
AB25 1HG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2009		Yes	No