A Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Bone mineral density at the L2-L4 lumbar spine region
研究概览
简要总结
A Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Lifenol® in Improving Bone Status in Postmenopausal Osteopenic Women. 100 postmenopausal women will be enrolled to investigate the effect of a 12 month supplementation with Lifenol® on bone density DXA parameters and plasma bone biomarkers.
详细描述
Osteoporosis is a skeletal disorder characterized by reduced bone mass and deterioration in bone architecture leading to an increased bone fragility and fracture risk. Postmenopausal women are a particularly at-risk population as the maintenance of bone homeostasis is influenced by estrogens. Recently, phytoestrogens have drawn attention as an interesting natural way to prevent oestrogen-deficient osteoporosis. Hops contain one of the most potent phytoestrogen known to date: 8-prenylnaringenin (8-PN). Lifenol® is a polyphenolic powdered extract obtained by a patented process from the female hop flowers (Humulus lupulus L.), standardized in 8-PN content.
Therefore, the present clinical trial aims to determine whether long-term consumption of Lifenol® can reduce bone mineral density loss in postmenopausal women with osteopenia taking traditional recommended calcium and vitamin D supplementation (1000 mg of calcium and 800 IU of vitamin D per day).
100 postmenopausal women (>1 year post-menopause) will be enrolled to consume during 12 months either Lifenol® (dose of 100µg of 8-PN per day) or a placebo. Effect of investigational product will be measured notably on bone density DXA parameters and plasma bone biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Be able to give written informed consent;
- •Be 50 - 85 years of age;
- •Be a free-living postmenopausal (> 1 year post menopause) woman;
- •Have a Body Mass Index (BMI) 18 - 32.0 kg/m²;
- •Present with a stable weight (+/- 3 kg) for at least the last three (3) months;
- •Be a non-smoker
- •Maintain existing food and physical activity patterns throughout the study period;
- •Present with osteopenia defined as a dual energy X-ray absorptiometry (DXA) T score comprised between -1 and -2.5;
- •Be willing to consume the investigational product daily for the duration of the study.
- •Be able to give written
排除标准
- •Are hypersensitive to any of the components of the investigational product;
- •Is currently involved in any other clinical trial or having participated in a trial within the preceding 60 days;
- •Has a diagnosis of osteoporosis (defined as a T score strictly inferior to -2.5);
- •Is currently a smoker;
- •Trying to lose weight for the last three (3) months (following a diet or exercise regimen designed for weight loss);
- •Recent (within 4 weeks) gastroenteritis or food borne illness;
- •Having taken antibiotics or laxatives during the preceding 2 months or anticipated consumption;
- •Currently taking (and during the past 3 months) any drug for osteoporosis (bisphosphonates, parathyroid hormone, strontium ranelate or denosumab);
- •Currently taking (and during the past 3 months) treatment with oestrogen or hormone therapy;
- •Currently taking (and during the past 3 months) treatment with oestrogen agonist or antagonist products (raloxifene or tamoxifene);
- •Currently taking any supplementation with isoflavones or foods fortified with isoflavones;
- •Currently taking (and during the past 4 weeks) any vitamin K supplementation.
- •Exhibiting excess alcohol consumption, defined as greater than 11 standard drinks per week for women or drug dependence,
- •Has a significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude supplement ingestion and/or assessment of safety and the study objectives;
- •Has a known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease;
- •Has a history of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, or carcinoma in situ with no significant progression over the past 2 years;
- •Has uncontrolled hypertension (systolic or diastolic blood pressure superior to 160 and 110 respectively). Subject on hypertension medication, must be on stable medication for 3 months;
- •Has uncontrolled hypothyroidism or hyperthyroidism; subject must be stable on medication for 3 months
- •Current illnesses which could interfere with the study (e.g. prolonged severe diarrhoea, regurgitation/severe, difficulty swallowing).
- •Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
研究组 & 干预措施
Lifenol
50 participants who meet the eligibility criteria will be randomised under active arm and will receive Lifenol product during 12 months
干预措施: Lifenol® (Dietary Supplement)
Placebo
50 participants who meet the eligibility criteria will be randomised under Placebo arm and will receive placebo product during 12 months
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Bone mineral density at the L2-L4 lumbar spine region
时间窗: baseline and 12 months
Change of bone mineral density at L2-L4 lumbar spine region over 12 months.
次要结局
- T-score(baseline, 6 and 12 months)
- Fracture risk assessment tool (FRAX) score(baseline, 6 and 12 months)
- Bone mineral density at the femoral neck region(baseline, 6 and 12 months)
- Quality of life evaluation(baseline, 3, 6, 9 and 12 months)
- Plasma prenylflavonoids(baseline, 6 and 12 months)
- Bone mineral content at the L2-4 lumbar spine and femoral neck region(baseline, 6 and 12 months)
- Plasma bone biomarkers(baseline, 6 and 12 months)
- Glucose homeostasis and lipid profile(baseline, 6 and 12 months)
- Gastrointestinal tolerance evaluation(baseline, 3, 6, 9 and 12 months)