Effect of a low-carbohydrate diet on the bone and cardiovascular health in females

Completed

• Conditions: Bone and cardiovascular health; Musculoskeletal Diseases

• Registration Number: ISRCTN48034106
• Lead Sponsor: Waterford Institute of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-25
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

1. Females aged between 39 and 65
2. Body Mass Index (BMI) between 25 and 30

Exclusion Criteria

1. Pregnancy or lactation
2. One hormone replacement therapy
3. Currently engaging in intense physical activity
4. History of chronic menstrual irregularities
5. Have had a hystorectomy
6. Have an osteoporosis T score of less then -1
7. Those suffering from diabetes mellitus, kidney disease, chronic illness, inflammatory conditions, renal, gastrointestinal or hormonal disorders
8. Those suffering from rheumatoid arthritis, osteo-arthritis or metabolic diseases of the bone e.g. osteoporosis or Piaget’s disease
9. If the subject had engaged in dieting practices in the 6 months prior to the study (including a low carbohydrate diet)
10. Excessive smokers or alcohol drinkers
11. Taking drugs known to affect bone metabolism, other prescribed drugs such as diuretics, antibiotics, antacids and Cox-2 inhibitors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The effect of nutrient intake (macro-nutrient and micronutrients measured using food diaries analysed on CompEat dietary analysis software) on bone health (bone mineral mass and density and indicators of bone formation and resorption). Serum markers of bone turnover (bone-specific alkaline phosphatase (BSAP), osteocalcin (S-OC) and C-terminal peptide of collagen type-1 (S-CTx)), insulin, IGF-1 & IGFBP-3 were all measured by Enzyme-Linked Immuno Sorbent Assay (ELISA). This was measured at 3 and 6 months.<br>2. . The effect of nutrient intake (macro-nutrient and micronutrients) on cardiovascular health (measured through endothelial microparticles, blood cholesterol and endothelial inflammatory biomarkers). This was measured at 3 and 6 months.

Secondary Outcome Measures

Name	Time	Method
1. Weight loss (weight and height were recorded using an electronic balance and stadiometer) as a result of the low carbohydrate diet and net endogenous acid production (NEAP) as a result of lower carbohydrate ratio. This was measured at 3 and 6 months.<br>2. Net endogenous acid production (NEAP) as a result of lower carbohydrate ratio. Net Endogenous Acid Production (NEAP) was calculated based on the method described be Remer et al. (2003). This was measured at 3 and 6 months.