Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women

Osteopenia, Generalized Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04004013
• Other study ID #: AFCRO-100
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 11, 2020

Study information

• Verified date: January 2021
• Source: Naturex SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 11, 2020
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia, Generalized

Intervention

Dietary Supplement:
• Lifenol®
Lifenol®, powdered extract obtained from female hops flowers (Humulus lupulus L.) standardized in 8-PN content (100 µg /day) + maltodextrin = 500 mg/capsule + 1000 mg of calcium and 800 IU of vitamin D per day
• Placebo
Maltodextrin = 500 mg/capsule + 1000 mg of calcium and 800 IU of vitamin D per day

Locations

Country	Name	City	State
Ireland	Atlantia Food Clinical Trials	Cork

Sponsors (2)

Lead Sponsor	Collaborator
Naturex SA	Atlantia Food Clinical Trials

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density at the L2-L4 lumbar spine region	Change of bone mineral density at L2-L4 lumbar spine region over 12 months.	baseline and 12 months
Secondary	Bone mineral density at the femoral neck region	DXA scan will provide this parameter	baseline, 6 and 12 months
Secondary	Bone mineral content at the L2-4 lumbar spine and femoral neck region	DXA scan will provide this parameter	baseline, 6 and 12 months
Secondary	T-score	DXA scan will provide this parameter	baseline, 6 and 12 months
Secondary	Fracture risk assessment tool (FRAX) score	FRAX score will be calculated an online tool (university of sheffield frax tool).	baseline, 6 and 12 months
Secondary	Plasma bone biomarkers	Change in plasma bone biomarkers will be measured.	baseline, 6 and 12 months
Secondary	Plasma prenylflavonoids	Change in plasma prenylflavonoids will be measured.	baseline, 6 and 12 months
Secondary	Glucose homeostasis and lipid profile	Change in plasma glucose, insulin and lipids will be measured.	baseline, 6 and 12 months
Secondary	Quality of life evaluation	36-item short form (SF-36) will be performed to assess by quality of life.	baseline, 3, 6, 9 and 12 months
Secondary	Gastrointestinal tolerance evaluation	Gastrointestinal tolerance of the product will be assessed by the Gastrointestinal Symptom Rating Scale (GSRS).	baseline, 3, 6, 9 and 12 months