None listed
Conditions
Brief summary
Our research focuses on nutritional strategies for bone health to prevent osteoporosis and reduce the risk of fractures in overweight post-menopausal women. Osteoporosis and obesity both impose major cost burdens for their associated care. There is increasing evidence of a high prevalence of fractures in overweight and obese people. There are approximately 400 fractures per day in Australia as a result of osteoporosis. Breaking a bone is very painful but there are longer term effects such as difficulty in walking and it has now been shown that fracture contribute to premature death. Osteoporosis arises when bones lose calcium more quickly than it can be replaced, reducing their strength. Although only a small amount of calcium is present in blood; this calcium is essential for the functioning of the heart, muscles and nerves. So far, studies have mainly investigated impact of calcium supplementation in reducing bone loss in normal weight women. However there are increasing numbers of overweight women in our community and therefore it could be that dietary calcium does not have the same benefits for bone health in overweight women as it does in thin women. Our research aims to answer two important questions:- 1) Can dietary calcium protect the bones of overweight and obese post-menopausal women? 2) Which form of calcium intake, calcium from food or calcium as supplement, is better for overweight/obese post-menopausal women.
Interventions
This is a randomized open-labeled crossover study. The participants will be recruited through Facebook advertisement. Interested participants will attend the clinical trial facility at the University of South Australia on four different occasions, one week apart. During the screening visit, all subjects will undergo body weight measurements, standing height and waist-hip ratio (WHR). Based on their body mass index (BMI), participants will be recruited such that we have 66 each in the thin (BMI l
This is a randomized open-labeled crossover study. The participants will be recruited through Facebook advertisement. Interested participants will attend the clinical trial facility at the University of South Australia on four different occasions, one week apart. During the screening visit, all subjects will undergo body weight measurements, standing height and waist-hip ratio (WHR). Based on their body mass index (BMI), participants will be recruited such that we have 66 each in the thin (BMI less than or equal to 25 Kg/m2) and overweight group (BMI greater than 27 kg/m2). Each enrolled participants will be assigned a code known only to the investigator and a randomization sequence for the three products will be generated. The following week, participants will return to the laboratory. On each of the test day, blood samples will be collected at baseline (after 12 hours overnight fast). Each participant will then be administered a single dose of any one product based on their respective randomization sequence and will be asked to consume the same within 15min. The time at which they finish the drink will be recorded and referred to as time zero. Blood samples will then be collected subsequently at 30 min, 1, 2, 3, 4 and 5 hour time points. The products will be: Experimental Arm 1: Two pills of Calcium carbonate Experimental Arm 2: High calcium milk Control arm: A non-fortified fruit drink The products in the experimental arms 1 and 2 will deliver 1000mg calcium each. Each intervention will be separated by a washout period of one week, hence every participant will act as her own control. Body composition will be assessed using Dual-X-ray Absorptiometry (DEXA) at any of the visits based on participant convenience.
Sponsors
University of South Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Apparently healthy post-menopausal women, at least 5 years since menopause with BMI less than 25kg/m2 or greater than 27kg/m2
Exclusion criteria
Post-menopausal women (at least 5 years post-menopause) who are : 1. On any prescribed osteoporotic medication (e.g. Prolia, Alendronate, Zoledronate etc.) 2. Lactose intolerant 3. Diabetic 4. Have kidney disorders
Outcome results
None listed