Comparison of varying dietary interventions in an obese population
| ISRCTN | ISRCTN09760867 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09760867 |
| Secondary identifying numbers | N/A |
- 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
Scientific
The Robert Gordon University
Centre for Obesity Research and Epidemiology
St. Andrew Street
Aberdeen
AB25 1HG
United Kingdom
| j.broom@rgu.ac.uk |
Study information
| Study design | Single centre randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | Weight loss, measured in kilograms before screening, at screening and 3 and 9 months post-screening. |
| Secondary outcome measures | 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. |
| Overall study start date | 03/02/2005 |
| Completion date | 30/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- Scotland
- United Kingdom
Study participating centre
The Robert Gordon University
Aberdeen
AB25 1HG
United Kingdom
AB25 1HG
United Kingdom
Sponsor information
The Robert Gordon University (UK)
University/education
University/education
Centre for Obesity Research and Epidemiology
St. Andrew Street
Aberdeen
AB25 1HG
Scotland
United Kingdom
| j.broom@rgu.ac.uk | |
| Website | http://www.rgu.ac.uk/ |
"ROR" |
https://ror.org/04f0qj703 |
Funders
Funder type
Industry
LighterLife UK Limited (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
