Effects of resistance training and animal protein intake on dietinduced weight loss in obese older women displaying metabolic abnormalities
| ISRCTN | ISRCTN51723391 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51723391 |
| Protocol serial number | OTG 88590 |
| Sponsor | University of Sherbrooke (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) (ref: OTG 88590) |
- Submission date
- 31/08/2011
- Registration date
- 25/01/2012
- Last edited
- 25/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Previous studies show that the percentage of obese female population at a given time is particularly high in women aged 50 to 75 years, in Canada and United States. The higher rate of occurence of obesity in postmenopausal women (PM) may be caused in part by the menopause transition; which is associated with changes in ovarian hormone status, decrease in energy expenditure, increase in fat mass (FM) and cardiovascular diseases risk factors. Part of this risk may be explained by changes in body composition and body fat distribution. PM women tend to gain fat mass mainly in the abdominal region, which is associated with lower insulin sensitivity (a condition where the natural hormone insulin, becomes less effective at lowering blood sugars). These metabolic changes, along with abnormal amount of cholesterol (dyslipidemia) and increased blood pressure (hypertension) are commonly associated with the metabolic syndrome and may predict type 2 diabetes and coronary artery disease in PM women.
Several medical and behavioural approaches have been studied over the past decades in order to prevent or treat obesity. Still, caloric restriction (dietary regimen that restricts calorie intake) and physical activity are the main factors in prevention and treatment of obesity.
The aim of this study is to study the effects of caloric restriction alone or in combination with resistance training on body composition, body fat distribution, metabolic profile and energy expenditure in obese PM women, when taking into account animal protein intakes.
Who can participate?
100 postmenopausal women (60-75 yrs and body mass index between 27 and 40 kg/m²)
What does the study involve?
Subjects will be randomised in one of the 4 groups:
1. Standard hypocaloric diet
2. Standard hypocaloric diet + resistance training
3. Standard hypocaloric diet + animal proteins supplement and
4. Standard hypocaloric diet + animal proteins supplement + resistance training.
What are the possible benefits and risks of participating?
Subjects will receive:
1. Professional supervision regarding nutrition and/or exercise during the study (depending on the treatment group)
2. Professional advises and recommendations regarding nutrition and exercise following the study based on personal results before and after the study
3. Improvements in body composition, body fat distribution and the metabolic profile (blood pressure, lipids and glucose blood levels and
4. Improvements in physical capacity. At the end of the study, each subject will receive a personalized document including data regarding body composition, metabolic, physical capacity and nutrition changes during the study.
The participation to an exercise program involves a risk of injuries which we intend to minimize by creating a progressive protocol. In addition to that, the exercise sessions will be supervised. The exposition to X-rays during DXA (from 0.03 to 0.05 millirem) is comparable to 20 minutes of sun exposition. The principal investigator has several reasons to believe that the advantages to participate in the study overcomes the risks.
Where is the study run from?
Sherbrooke: Centre for Research on Aging, Center for Health and Social Services of the University Institute of Geriatrics of Sherbrooke (CRV - CSSS-IUGS) and Montreal: Clinical Research Institute of Montreal (IRCM)
When is study starting and how long is it expected to run for?
The project is expected to start in January 2012. The anticipated end date is January 2014.
Who is funding the study?
Canadian Institutes of Health Research (CIHR)
Who is the main contact?
Prof Martin Brochu
Martin.Brochu@USherbrooke.ca
Contact information
Scientific
Centre de recherche sur le vieillissement du CSSS-IUGS
1036, rue Belvédère Sud
Sherbrooke
J1K 2R1
Canada
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of resistance training and animal protein intake on dietinduced weight loss in obese older women displaying metabolic abnormalities: a randomized controlled trial |
| Study objectives | The combination of caloric restriction + high protein intake + resistance training will be associated with 1. Gain in lean body mass (LBM) and greater decreases in fat mass (FM) 2. Higher total daily energy expenditure (because of better preservation in LBM) and 3. Better improvements in lipids and glucose homeostasis (because of better preservation in LBM and higher daily energy expenditure) |
| Ethics approval(s) | Ethics Committee of the Aging Research Centre for Health and Social Services of the University Institute of Geriatrics of Sherbrooke (Comité déthique de la recherche sur le vieillissement du Centre de santé et de services sociaux de l'Institut universitaire de gériatrie de Sherbrooke), May 19th, 2011 (ref: 2011-04/BROCHU) |
| Health condition(s) or problem(s) studied | Obesity, menopause, metabolic syndrome, physical capacity. |
| Intervention | All groups will be followed for 24 weeks (4 weeks of weight stabilisation before and after the intervention + 16 weeks of weight loss program). Women will be randomized to one of the four following groups: 1. Standard hypocaloric diet 2. Standard hypocaloric diet + resistance training 3. Standard hypocaloric diet + animal proteins supplement and 4. Standard hypocaloric diet + animal proteins supplement + resistance training Standard hypocaloric diet: This diet should induce an average caloric deficit between 500 and 1000 kcal/day (weight loss between 1 and 2 lbs per week). The diet will be based on the Canadian food guide (15% of proteins, 30% of lipids and 50% of carbohydrates). The average daily protein intake should be 0.8 gram per kg of body weight. Animal proteins supplement: Subjects will be asked to consume a supplement of 25 grams of animal proteins each day. For those in the resistance training group, the supplement will be taken within 2 hours after training on day of training. Resistance training (RT): Women in RT groups will train three times a week on non-consecutive days, under the supervision of an exercise physiologist. All training sessions will start with a warm-up period consisting of 5 min of low-intensity cycling. Participants then performed the load phase of RT consisting in 3 series of 8 repetitions for nine different exercises. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Dual energy X-ray absorptiometry (DXA) technology to measure total fat mass, bone mass and lean body mass as well as each tissue by region (trunk, legs and arms). |
| Key secondary outcome measure(s) |
1. Lipids, glucose homeostasis, inflammation profile, adipokines, energy expenditure, resting arterial blood pressure and heart rate, physical capacity and psychosocial determinants |
| Completion date | 09/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Women will be included in the study if they had stopped menstruating for more than 1 yr, and if they have follicle stimulating hormone (FSH) levels > 30 U/L 2. Aged between 60 and 75 years old 3. Body mass index (BMI) between 27 and 40 kg/m2 4. Sedentary (< 2 times a week of exercise) 5. Non-smokers 6. Low to moderate alcohol consumers (< 2 drinks/week) 7. Displaying at least one of the following factor of the metabolic syndrome accordingly to the Adult Treatment Panel III (ATP IIIs) definition [63] [triglycerides > 1.70 mmol/L; high density lipoprotein (HDL)-cholesterol < 1.29 mmol/L; resting blood pressure < 160/95 mmHg (treated or not); fasting plasma glucose > 6.1 mmol/L], 7) stable medication(s) for the metabolic syndrome since 6 weeks and 8. Glycated haemoglobin (HbA1c) < 8% |
| Key exclusion criteria | 1. More than three medications for high blood pressure 2. Cardiovascular disease and peripheral vascular disease within 3 months 3. Stroke within 3 months and/or causing inability to complete the exercice program 4. Diabetes treated with insulin 5. Cancer within 5 years (excepted skin and thyroid cancer) 6. Severe hypertension (resting blood pressure > 160/95 mmHg under stable treatement) 7. Total cholesterol > 8 mmol/L 8. Triglycerides >10 mmol/L 9. Low density lipoprotein (LDL)-chol > 4 mmol/L 9. Body weight fluctuation > 3 kg in the previous six months 10. Pituitary disease 11. Renal insufficiency (creatine <45 ml/min) 12. Orthopaedic problems causing inability to complete the exercice program 13. Protein intake <0.8 g/kg or >1.2 g/kg body mass per day |
| Date of first enrolment | 09/01/2012 |
| Date of final enrolment | 09/01/2014 |
Locations
Countries of recruitment
- Canada
Study participating centre
J1K 2R1
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
