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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteopenia, Generalized
• Intervention / Treatment: Dietary supplement: Lifenol®; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland, T23 R50R
    • Atlantia Food Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lifenol; 50 participants who meet the eligibility criteria will be randomised under active arm and will receive Lifenol product during 12 months	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 Comparator: Placebo; 50 participants who meet the eligibility criteria will be randomised under Placebo arm and will receive placebo product during 12 months	Dietary supplement: Placebo; Maltodextrin = 500 mg/capsule + 1000 mg of calcium and 800 IU of vitamin D per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone mineral density at the femoral neck region	DXA scan will provide this parameter	baseline, 6 and 12 months
Bone mineral content at the L2-4 lumbar spine and femoral neck region	DXA scan will provide this parameter	baseline, 6 and 12 months
T-score	DXA scan will provide this parameter	baseline, 6 and 12 months
Fracture risk assessment tool (FRAX) score	FRAX score will be calculated an online tool (university of sheffield frax tool).	baseline, 6 and 12 months
Plasma bone biomarkers	Change in plasma bone biomarkers will be measured.	baseline, 6 and 12 months
Plasma prenylflavonoids	Change in plasma prenylflavonoids will be measured.	baseline, 6 and 12 months
Glucose homeostasis and lipid profile	Change in plasma glucose, insulin and lipids will be measured.	baseline, 6 and 12 months
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
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

Collaborators and Investigators

• Sponsor: Naturex SA
• Collaborators: Atlantia Food Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): December 11, 2020
• Study Completion (Actual): December 11, 2020

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: menopause; phytoestrogen; osteopenia; hop
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: AFCRO-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: To revisit this after investigation period

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No