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

NCT04004013 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-01-06

No results posted yet for this study

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

Interventions

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • Givaudan France Naturals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2020-12-11
Completion
2020-12-11

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04004013 on ClinicalTrials.gov