Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/09/2008
Date assigned
15/09/2008
Last edited
27/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Iain Broom

ORCID ID

Contact details

The Robert Gordon University
Centre for Obesity Research and Epidemiology
St. Andrew Street
Aberdeen
AB25 1HG
United Kingdom
j.broom@rgu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised clinical trial of standard dietary treatment versus protein-sparing modified fast or the LighterLife Programme in the management of obesity

Acronym

Study hypothesis

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

Ethics approval received from the North of Scotland Research Ethics Service on the 3rd February 2005 (ref: 05/S0802/03).

Study design

Single centre randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

03/02/2005

Overall trial end date

30/11/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

03/02/2005

Recruitment end date

30/11/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Robert Gordon University
Aberdeen
AB25 1HG
United Kingdom

Sponsor information

Organisation

The Robert Gordon University (UK)

Sponsor details

Centre for Obesity Research and Epidemiology
St. Andrew Street
Aberdeen
AB25 1HG
United Kingdom
j.broom@rgu.ac.uk

Sponsor type

University/education

Website

http://www.rgu.ac.uk/

Funders

Funder type

Industry

Funder name

LighterLife UK Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/20923540

Publication citations

  1. Results

    Rolland C, Hession M, Murray S, Wise A, Broom I, Randomized clinical trial of standard dietary treatment versus a low-carbohydrate/high-protein diet or the LighterLife Programme in the management of obesity*., J Diabetes, 2009, 1, 3, 207-217, doi: 10.1111/j.1753-0407.2009.00033.x.

Additional files

Editorial Notes