Clinical trial NCT04004013: Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women
Official title: A Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia, Generalized
Keywords: osteopenia
phytoestrogen
hop
menopause
Lead sponsor: Givaudan France Naturals
Sponsor class: INDUSTRY
Collaborators: name: Atlantia Food Clinical Trials
First posted: 2019-07-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Be able to give written informed consent;
2. Be 50 - 85 years of age;
3. Be a free-living postmenopausal (\> 1 year post menopause) woman;
4. Have a Body Mass Index (BMI) 18 - 32.0 kg/m²;
5. Present with a stable weight (+/- 3 kg) for at least the last three (3) months;
6. Be a non-smoker
7. Maintain existing food and physical activity patterns throughout the study period;
8. Present with osteopenia defined as a dual energy X-ray absorptiometry (DXA) T score comprised between -1 and -2.5;
9. Be willing to consume the investigational product daily for the duration of the study.

Be able to give written

Exclusion Criteria:

1. Are hypersensitive to any of the components of the investigational product;
2. Is currently involved in any other clinical trial or having participated in a trial within the preceding 60 days;
3. Has a diagnosis of osteoporosis (defined as a T score strictly inferior to -2.5);
4. Is currently a smoker;
5. Trying to lose weight for the last three (3) months (following a diet or exercise regimen designed for weight loss);
6. Recent (within 4 weeks) gastroenteritis or food borne illness;
7. Having taken antibiotics or laxatives during the preceding 2 months or anticipated consumption;
8. Currently taking (and during the past 3 months) any drug for osteoporosis (bisphosphonates, parathyroid hormone, strontium ranelate or denosumab);
9. Currently taking (and during the past 3 months) treatment with oestrogen or hormone therapy;
10. Currently taking (and during the past 3 months) treatment with oestrogen agonist or antagonist products (raloxifene or tamoxifene);
11. Currently taking any supplementation with isoflavones or foods fortified with isoflavones;
12. Currently taking (and during the past 4 weeks) any vitamin K supplementation.
13. Exhibiting excess alcohol consumption, defined as greater than 11 standard drinks per week for women or drug dependence,
14. 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;
15. Has a known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease;
16. 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;
17. 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;
18. Has uncontrolled hypothyroidism or hyperthyroidism; subject must be stable on medication for 3 months
19. Current illnesses which could interfere with the study (e.g. prolonged severe diarrhoea, regurgitation/severe, difficulty swallowing).
20. 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.

Primary outcomes:
measure: Bone mineral density at the L2-L4 lumbar spine region
timeFrame: baseline and 12 months
Secondary outcomes:
measure: Bone mineral density at the femoral neck region
timeFrame: baseline, 6 and 12 months
measure: Bone mineral content at the L2-4 lumbar spine and femoral neck region
timeFrame: baseline, 6 and 12 months
measure: T-score
timeFrame: baseline, 6 and 12 months
measure: Fracture risk assessment tool (FRAX) score
timeFrame: baseline, 6 and 12 months
measure: Plasma bone biomarkers
timeFrame: baseline, 6 and 12 months
measure: Plasma prenylflavonoids
timeFrame: baseline, 6 and 12 months
measure: Glucose homeostasis and lipid profile
timeFrame: baseline, 6 and 12 months
measure: Quality of life evaluation
timeFrame: baseline, 3, 6, 9 and 12 months
measure: Gastrointestinal tolerance evaluation
timeFrame: baseline, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Atlantia Food Clinical Trials
Study officials:
References: