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

NCT04004013 | Completed

• 1 other identifier: AFCRO-100
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia, Generalized

Keywords

osteopenia; phytoestrogen; hop; menopause

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Bone mineral density at the femoral neck region

  baseline, 6 and 12 months

• Bone mineral content at the L2-4 lumbar spine and femoral neck region

  baseline, 6 and 12 months

• T-score

  baseline, 6 and 12 months

• Fracture risk assessment tool (FRAX) score

  baseline, 6 and 12 months

• Plasma bone biomarkers

  baseline, 6 and 12 months

Study Arms (2)

Lifenol

ACTIVE COMPARATOR

50 participants who meet the eligibility criteria will be randomised under active arm and will receive Lifenol product during 12 months

Dietary Supplement: Lifenol®

Placebo

PLACEBO COMPARATOR

50 participants who meet the eligibility criteria will be randomised under Placebo arm and will receive placebo product during 12 months

Dietary Supplement: Placebo

Interventions

Lifenol® DIETARY_SUPPLEMENT

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

Lifenol

Placebo DIETARY_SUPPLEMENT

Maltodextrin = 500 mg/capsule \+ 1000 mg of calcium and 800 IU of vitamin D per day

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Givaudan France Naturals: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Food Clinical Trials

Cork, T23 R50R, Ireland

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: July 1, 2019
• Study Start: August 1, 2019
• Primary Completion: December 11, 2020
• Study Completion: December 11, 2020
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

IE (1)