NCT03026660

Brief Summary

The purpose of this study is to determine the effects of Moringa Oleifera on the structure and function of bone in post-menopausal women ingesting 1000 mg of Moringa Oleifera daily for 12 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

January 16, 2017

Last Update Submit

January 18, 2017

Conditions

Osteoporosis, OsteopeniaPostmenopausal Osteoporosis

Keywords

Moringa Oleifera

Outcome Measures

Primary Outcomes (1)

  • Bone Density

    Measured by Dual Energy X-Ray Absorptiometry

    12 weeks after start of intervention

Study Arms (2)

Moringa treatment

EXPERIMENTAL

Moringa Oleifera was distributed in two 500mg capsules of dried and powdered Moringa Oleifera leaves. Two capsules were taken daily.

Dietary Supplement: Moringa Oleifera

Placebo

PLACEBO COMPARATOR

The placebo consisted of dried and powdered cabbage in two 500mg capsules. Two capsules were taken daily.

Dietary Supplement: Cabbage Placebo

Interventions

Moringa OleiferaDIETARY_SUPPLEMENT
Moringa treatment
Cabbage PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age60 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales only
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 60 -70 years old
  • Female

You may not qualify if:

  • Fracture in non-dominant forearm/wrist or lower leg.
  • Currently taking blood thinners
  • Currently taking estrogen supplements
  • Have had a hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Appalachian State University

Boone, North Carolina, 28608, United States

Location

Related Publications (7)

  • Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007 Mar;22(3):465-75. doi: 10.1359/jbmr.061113.

    PMID: 17144789BACKGROUND

  • Popoola JO, Obembe OO. Local knowledge, use pattern and geographical distribution of Moringa oleifera Lam. (Moringaceae) in Nigeria. J Ethnopharmacol. 2013 Nov 25;150(2):682-91. doi: 10.1016/j.jep.2013.09.043. Epub 2013 Oct 2.

    PMID: 24096203BACKGROUND

  • Thurber MD, Fahey JW. Adoption of Moringa oleifera to combat under-nutrition viewed through the lens of the "Diffusion of innovations" theory. Ecol Food Nutr. 2009 May-Jun;48(3):212-25. doi: 10.1080/03670240902794598.

    PMID: 20161339BACKGROUND

  • Singh V, Singh N, Pal US, Dhasmana S, Mohammad S, Singh N. Clinical evaluation of cissus quadrangularis and moringa oleifera and osteoseal as osteogenic agents in mandibular fracture. Natl J Maxillofac Surg. 2011 Jul;2(2):132-6. doi: 10.4103/0975-5950.94466.

    PMID: 22639499BACKGROUND

  • Zeng FF, Xue WQ, Cao WT, Wu BH, Xie HL, Fan F, Zhu HL, Chen YM. Diet-quality scores and risk of hip fractures in elderly urban Chinese in Guangdong, China: a case-control study. Osteoporos Int. 2014 Aug;25(8):2131-41. doi: 10.1007/s00198-014-2741-2. Epub 2014 May 27.

    PMID: 24861906BACKGROUND

  • Storm D, Eslin R, Porter ES, Musgrave K, Vereault D, Patton C, Kessenich C, Mohan S, Chen T, Holick MF, Rosen CJ. Calcium supplementation prevents seasonal bone loss and changes in biochemical markers of bone turnover in elderly New England women: a randomized placebo-controlled trial. J Clin Endocrinol Metab. 1998 Nov;83(11):3817-25. doi: 10.1210/jcem.83.11.5289.

    PMID: 9814452BACKGROUND

  • Nandave M, Ojha SK, Joshi S, Kumari S, Arya DS. Moringa oleifera leaf extract prevents isoproterenol-induced myocardial damage in rats: evidence for an antioxidant, antiperoxidative, and cardioprotective intervention. J Med Food. 2009 Feb;12(1):47-55. doi: 10.1089/jmf.2007.0563.

    PMID: 19298195BACKGROUND

MeSH Terms

Conditions

OsteoporosisBone Diseases, MetabolicOsteoporosis, Postmenopausal

Interventions

flocculant protein MO 2.1, Moringa oleifera

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Edward K Merritt, PhD

    Appalachian State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 20, 2017

Study Start

July 1, 2015

Primary Completion

February 1, 2016

Study Completion

May 1, 2016

Last Updated

January 20, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)