Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women

Nestlé

Status and phase: Completed; Phase 2

Conditions: Osteoporosis; Osteopenia

Treatments: Other: Hesperidin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00545116

Nestec 06.34

Details and patient eligibility

About

The primary objective of this clinical trial is to determine the effects of hesperidin on biochemical markers of bone in post-menopausal women.

The secondary objectives are:

• To investigate changes in bone formation and bone resorption markers in response to hesperidin intake
• To compare the efficacy of hesperidin in a milk versus biscuit
• To collect safety information of hesperidin consumption in a human trial

Enrollment: 144 patients

Sex: Female

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Community dwelling women
• More than 4 years post-menopause (natural or surgical)
• Generally healthy as determined by standard medical assessment on physical and mental health
• Willing to comply with the study procedures
• Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data
• Having received both oral and written explanations about the study
• Having provided her written informed consent

Exclusion criteria

• Intestinal or severe metabolic diseases / disorders such as diabetes, renal, hepatic or pancreatic diseases / disorders, ulcer, hyperthyroidism, malignance, chronic malnutrition
• Have had major gastrointestinal surgery
• On therapy with drugs known to interfere with bone metabolism such as steroids, vitamin D or its derivatives, bisphosphonates, strontium ranelate, PTH, calcitonin, raloxifene, etc.
• Had sustained a fracture in the preceding 12 months
• On hormone replacement therapy (HRT) in the previous 3 months before entering the study
• Taking medications containing hesperidin (e.g.Daflon) or known to interfere with hesperidin (statins, therapy for circulatory disorders, anti-depressants)
• Known to have allergic reactions to citrus-containing foods
• Baseline calcium intake less than 500 mg/day
• Have an alcohol intake > 2 glasses of wine per day (3dL/day), or > 2 beers (3dL/d) or > 1 shot glass of hard alcohol
• Heavy smoker (more than 10 cigs a day)
• Special dietary habits (vegetarians)
• Phytoestrogens or antioxidants (dietary supplements) consumption

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 4 patient groups, including a placebo group

a

Experimental group

Description:

Active carrier 1: biscuit providing 250 mg hesperidin per piece(6g)

Treatment:

Other: Hesperidin

b

Experimental group

Description:

Active carrier 2: liquid skim milk providing 250 mg hesperidin/serve (200 ml) and containing around 300 mg calcium/serving

Treatment:

Other: Hesperidin

c

Placebo Comparator group

Description:

Placebo carrier 1: biscuit with the same nutrient composition and appearance as the active biscuit carrier but minus hesperidin

Treatment:

Other: Hesperidin

d

Placebo Comparator group

Description:

Placebo carrier 2: liquid skim milk with the same nutrient composition and appearance as the active milk carrier but minus hesperidin

Treatment:

Other: Hesperidin