Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/10/2013
Date assigned
07/01/2014
Last edited
16/04/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
An intermittent energy restriction (IER) approach to weight loss is easier for some people to follow as it involves short spells of severe energy restriction alternated with days of usual energy intake. However, there is currently not enough evidence regarding the potential effectiveness and benefits of IER compared with other food-based weight loss methods. We aim to compare the effectiveness of IER with continuous energy restriction (CER) on weight loss, blood glucose levels and markers of CVD risk in a selected group of NHS Rotherham Institute of Obesity (RIO) weight loss patients.

Who can participate?
Obese male and female patients, aged 18-65, attending a weight loss programme at the Rotherham Institute of Obesity are eligible to participate in this study.

What does the study involve?
The study will involve participating in a six-month weight loss programme. Participants will be randomly allocated to either the IER or the CER programme. The IER programme will be given in the form of the LighterLife Fast plan, which advocates 5 days unrestricted healthy eating and 2 days fasting, which consists of 4 fast LighterLife Foodpacks providing about 600 kcal each day. This will be compared with the CER programme, whereby patients will be instructed to consume a healthy diet with a daily deficit of about 500 kcal. Weight loss, changes in waist circumference as well as changes in blood glucose, fasting glucose and insulin, full lipids and inflammatory markers will be assessed. We will also assess changes in blood flow and blood pressure as well as dietary adherence using food diaries.

What are the possible benefits and risks of participating?
Patients will lose weight and may see improvements in other diseases associated with being obese. The study will contribute to a greater understanding and depth of knowledge about how well the different weight loss methods work and may provide the patient with a more acceptable way to lose and manage their weight. There are no foreseen disadvantages or risks of taking part.

Where is the study run from?
Rotherham Institute of Obesity, Rotherham, UK.

When is the study starting and how long is it expected to run for?
The study is expected to start in early February 2014 and will run for 6 months.

Who is funding the study?
Lighterlife UK Ltd, UK.

Who is the main contact?
Dr Kelly Johnston
01279 636998
Kelly.Johnston@lighterlife.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Matthew Capehorn

ORCID ID

Contact details

Rotherham Institute for Obesity (RIO)
Clifton Medical Centre
The Health Village
Doncaster Gate
Rotherham
S65 1DA
United Kingdom
+44 (0)844 477 3622
mcapehorn@yahoo.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Rotherham Institute for Obesity (RIO)/Lighterlife Fast

Study information

Scientific title

The comparative effects of continuous versus intermittent energy restriction (CER and IER respectively) on changes in weight, anthropometry and other cardio-metabolic disease risk markers in a selected cohort of RIO weight loss patients

Acronym

Study hypothesis

To compare the feasibility and efficacy of IER with CER on a range of outcomes measures including weight loss & anthropometry, measures of glycaemic control and appetite, and other biochemical markers of CVD risk..

Ethics approval

South Yorkshire NHS Ethics Committee, 14-YH-0018

Study design

Randomised non-blinded single-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Weight loss in obese individuals

Intervention

Randomised comparison using 200 overweight or obese, male and female participants (100 randomised to each group).

The IER leg of this study will be delivered in the form of the Lighterlife Fast 5:2 diet, which advocates 5 days healthy eating (consuming energy levels commensurate with weight maintenance) and 2 days fasting, which advises consumption of 4 fast Lighterlife Fast foodpacks providing 600 kcal on those two days. This will be compared with the CER leg of the study, whereby patients will be instructed to consume a healthy diet with a daily deficit of approximately 500 kcal.

The total duration of the intervention is 26 weeks. Participants on this trial remain patients of RIO and as such will be followed up regularly thereafter, but data will not be collected for this study.

Updated 16/04/2014:
Participants return at 12 months for the following measurements:
1. Weight
2. Height
3. BMI
4. Waist circumference
5. Hip circumference
6. Chest circumference
7. Blood pressure
8. Bio-impedance
9. Report on co-morbidities
10. Current medication

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Weight loss and changes in waist circumference

Secondary outcome measures

1. Changes in fasting glucose, lipids and insulin
2. Changes in liver function tests (LFTs), thyroid function tests (TFTs), Hba1c, adiponectin, leptin, C-reactive protein and IGF-1.
3. Changes in bio-impedance and blood pressure as well as dietary adherence using validated food diaries.

Baseline measurements and data:
Age
Gender
Weight
Height
BMI
Waist circumference
Hip circumference
Chest circumference
Blood pressure
Bio-impedance
Report on co-morbidities
Current medication
Blood sampling for serum collection
Blood sampling to measure full lipids, LFTs, TFTs, Hba1c, fasting glucose

Completed baseline 7-day diet diary as per instructions

4 week data:
Weight
BMI
Waist circumference
Hip circumference
Chest circumference
Blood pressure
Bio-impedance
Report on co-morbidities
Current medication
Blood sampling for serum collection
Blood sampling to measure full lipids, LFTs, TFTs, fasting glucose


8, 16, 20 week data:
Weight
BMI
Waist circumference
Hip circumference
Chest circumference
Blood pressure
Bio-impedance
Report on co-morbidities
Current medication

12, 26 week data:
Weight
BMI
Waist circumference
Hip circumference
Chest circumference
Blood pressure
Bio-impedance
Report on co-morbidities
Current medication
Completed 7-day diet diary as per instructions
Blood sampling for serum collection
Blood sampling to measure full lipids, LFTs, TFTs, fasting glucose

Overall trial start date

01/02/2014

Overall trial end date

31/08/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy males and females, aged 18-65
2. Body mass index (BMI) > 30

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Those who are pregnant or breastfeeding

Recruitment start date

01/02/2014

Recruitment end date

31/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rotherham Institute for Obesity (RIO)
Rotherham,
S65 1DA
United Kingdom

Sponsor information

Organisation

Lighterlife UK Ltd (UK)

Sponsor details

Cavendish House
Parkway
Harlow Business Park
Harlow
CM19 5QF
United Kingdom
+44 (0)127 963 6955
kelly.johnston@lighterlife.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Lighterlife (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes