Low-carbohydrate high-protein diet in obese diabetic subjects
| ISRCTN | ISRCTN20400186 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20400186 |
| Protocol serial number | N/A |
| Sponsor | The Robert Gordon University (UK) |
| Funder | Go Lower Limited (UK) |
- Submission date
- 05/09/2008
- Registration date
- 15/09/2008
- Last edited
- 29/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Single centred randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Alterations in the macronutrient content of the diet and effects on body composition, cardiovascular disease risk and the control of energy metabolism in obese patients with type II diabetes mellitus |
| Study objectives | To assess the weight loss achieved after 12 months on one of two hypoenergetic low-carbohydrate, high-protein diets (the protein sparing modified fast compared to commercial diet provided by the Go Lower company). |
| Ethics approval(s) | Ethics approval received from the North of Scotland Research Ethics Committees on the 15th April 2008 (ref: 08/S0801/54). |
| Health condition(s) or problem(s) studied | Obese, type 2 diabetics |
| Intervention | Patients will be assigned to either the protein sparing modified fast (PSMF) or the Go Lower diet. In both instances, patients will be given oral and written information about the diet. Patients on Go Lower will be given weekly food packs while the patients on PSMF will prepare their own food. Patients will be seen at 2 and 4 weeks post-randomisation and then monthly for a total of 1 year. |
| Intervention type | Other |
| Primary outcome measure(s) |
Weight change, measured in kilograms at baseline, 3, 6, 9 and 23 months. |
| 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), C-reactive protein (mg/L), fasting glucose (all in mmol/L), fasting insulin (uU/ml), HbA1c (%), waist circumference (cm), blood pressure (mmHg) |
| Completion date | 15/04/2010 |
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 between 18 and 75 years of age 2. Body Mass Index (BMI) greater than or equal to 30 kg/m^2 3. Poorly controlled type II diabetes mellitus (HbA1c greater than or equal to 7.5%) |
| Key exclusion criteria | 1. A history or current renal, hepatic disease or cancer 2. Have had a major coronary event in the last 6 months 3. Diet related diseases 4. On antidepressant or obesity-related pharmacotherapy 5. Current pregnancy or lactating |
| Date of first enrolment | 15/04/2008 |
| Date of final enrolment | 15/04/2010 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
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 |
Editorial Notes
29/06/2016: No publications found, verifying study status with principal investigator
