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

The effect of a six month low-carbohydrate diet on the biomarkers of bone and cardiovascular health in pre- and post-menopausal women: a randomised control crossover trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN48034106
Enrollment
24
Registered
2015-08-25
Start date
2009-05-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone and cardiovascular health Musculoskeletal Diseases

Interventions

Intervention Group: After initial measurements, participants consume a low carbohydrate diet for 6 months, followed by measurements and then resume normal diet for a further 6 months before having the

Sponsors

Waterford Institute of Technology
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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. 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

MeasureTime frame
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. 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.

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026