Protein intake metabolic effects study

Phase 2

• Conditions: Bone structure of elderly healthy women; Muscle mass of elderly healthy women; Renal function of elderly healthy women; Cardiovascular risk factors of elderly healthy women; Body composition of elderly healthy women; Musculoskeletal - Normal musculoskeletal and cartilage development and function; Cardiovascular - Normal development and function of the cardiovascular system; Renal and Urogenital - Normal development and function of male and female renal and urogenital system

• Registration Number: ACTRN12607000163404
• Lead Sponsor: A Professor RL Prince

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

Able to comply with the requirements of the protocol.

Exclusion Criteria

• Participation in another clinical trial during the last 12 weeks • Previous osteoporotic fracture• Currently or within last year taking medication for osteoporosis apart from calcium or vitamin D • Taking steroid tablets (eg Cortisone) in the past 3 months or have taken more than 7 g in total• Metabolic bone disease apart from osteoporosis• Total hip bone density more than 2SD below the mean for their age• Lactose intolerance or do not like milk products• High protein intake (more than 1.5 g/kg body weight per day)• Cognitive impairment (Mini Mental Sate score < 24)• Body mass index > 35 kg/cm2• Bowel surgery or difficulty absorbing food • Coeliac disease• Hepatic insufficiency or renal insufficiency • Participants who, in the opinion of the investigator are not likely to complete the study for any reason.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Bone structure of total body, hip, spine, forearm and tibia as measured by Dual Energy X-ray Absorptiometry and Quantitative Computed Tomography (QCT).[Measurements will be made at baseline, 1 and 2 years, except QCT of hip and spine, which will only be made at baseline and 2 years.];2) Body composition using anthropometry (height, weight, waist circumference, waist and hip ratio, skin fold), Dual Energy X-ray Absorptiometry body composition and CT abdominal fat.[Measurements will be made at baseline, 1 and 2 years, except QCT of hip and spine, which will only be made at baseline and 2 years.]

Secondary Outcome Measures

Name	Time	Method
1) Hand grip strength and lower limb muscle strength as assessed by hand dynamometer and strain gauge.[Measurements will be made at baseline, 1 and 2 years.];2) Mobility function as assessed by the Timed Up and Go test.[Measurements will be made at baseline, 1 and 2 years.];3) Insulin like growth factor I (IGF-I).[Measurements will be made at baseline, 1 and 2 years.];4) Biochemical markers of bone turnover.[Measurements will be made at baseline, 1 and 2 years.];5) Renal function as assessed by glomerular filtration rate [Measurements will be made at baseline, 1 and 2 years.];6) Risk factors of cardiovascular diseases (blood pressure, blood profiles of lipids and glucose, serum c-reactive protein, apolipoprotein E and homocystine). [Measurements will be made at baseline, 1 and 2 years.]