Comparison of varying dietary interventions in an obese population

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN09760867

Enrollment

120

Registered

2008-09-15

Start date

2005-02-03

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Nutritional, Metabolic, Endocrine Obesity

Interventions

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 inform

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 w

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Weight loss, measured in kilograms before screening, at screening and 3 and 9 months post-screening.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026