Trial | NCT00545116  Report issue

Title

Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women
Short-term Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women: a Randomized Placebo-controlled Trial

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    144
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
Study Started
Oct 31
2007
Primary Completion
Jan 31
2012
Study Completion
Jan 31
2012
Last Update
Oct 06
2015
Estimate

Other Hesperidin

250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months

a Experimental

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

b Experimental

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

c Placebo Comparator

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

d Placebo Comparator

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

Criteria 

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
No Results Posted