<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03026660</url>
  </required_header>
  <id_info>
    <org_study_id>15-0257</org_study_id>
    <nct_id>NCT03026660</nct_id>
  </id_info>
  <brief_title>Moringa Oleifera on Bone Density</brief_title>
  <official_title>Effect of Moringa Oleifera on Bone Density in Post-Menopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Appalachian State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>North Carolina Agriculture &amp; Technical State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Appalachian State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effects of Moringa Oleifera on the structure&#xD;
      and function of bone in post-menopausal women ingesting 1000 mg of Moringa Oleifera daily for&#xD;
      12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Moringa Oleifera (M. Oleifera) is a tropical plant native to northern India, Pakistan,&#xD;
      Himalayan regions, Africa, Central America, and Arabia that has been used for centuries in&#xD;
      ethnic cultures all over the world. M. Oleifera is exceptionally rich in a variety of&#xD;
      nutrients and medicinal phytochemicals, including those that promote bone density, such as&#xD;
      vitamin D, calcium, phosphorus, magnesium and others. M. Oleifera also contains&#xD;
      micronutrients that play a critical role in bone health and in calcium absorption, such as&#xD;
      boron, vitamin C, magnesium, potassium, phosphorous and others. For instance, boron&#xD;
      stabilizes and extends the half-life of vitamin D; magnesium (Mg) affects the activities of&#xD;
      osteoblasts and osteoclasts, as well as bone homeostasis by modulating the concentration of&#xD;
      parathormone and the activated form of vitamin D. Magnesium also contributes to bone&#xD;
      structural development; vitamin K reduces bone turn over, improves bone strength and plays an&#xD;
      essential role in osteocalcin carboxylation and vitamin C increases bone density and strength&#xD;
      by increasing collagen formation and promotes healing during fracture. Collectively, these&#xD;
      micronutrients in M. Oleifera are expected to significantly impact bone health. Given this&#xD;
      knowledge, the purpose of the present study is to determine the effects of M. Oleifera on the&#xD;
      structure and function of bone in post-menopausal women ingesting 1 gram of M. Oleifera daily&#xD;
      for 12 weeks using DEXA scans.&#xD;
&#xD;
      The fresh young leaves of Moringa oleifera (about 2 years old) were collected by Dr. Joshua&#xD;
      Idassi, from a field and high tunnel plots at the North Carolina Agriculture and Technical&#xD;
      State University farm in July, 2014. Botanical identification and authentication were&#xD;
      performed by Dr. Joshua Idassi, Natural Resources Specialist, from the Cooperative Extension&#xD;
      Program, North Carolina A &amp; T. A voucher specimen (LUH 2923) was deposited in the herbarium&#xD;
      of the University of Lagos, Akoka, Yaba, Lagos. Fresh leaves of M. Oleifera were air-dried&#xD;
      for about 7 days at 30 ◦C and macerated into a fine powder.&#xD;
&#xD;
      Twenty-four untrained post-menopausal women (60-70 years old) were randomly assigned to&#xD;
      either the control or placebo group (no program) or the experimental /treatment group (M.&#xD;
      Oleifera supplement group). Both groups orally ingested 1 gram (1000 mg) daily of cabbage&#xD;
      (placebo) or M. Oleifera (treatment group) leaf powder in capsules for 12 weeks. The bone&#xD;
      scans were then taken pre-supplementation and after 12 weeks to determine the effects of M.&#xD;
      Oleifera on various bone parameters, including bone mass density, bone mineral content, and&#xD;
      select anthropomorphic results including weight, body fat percentage, and lean mass&#xD;
      percentage.&#xD;
&#xD;
      The first visit to the laboratory by participants was utilized for providing them with&#xD;
      general information and as a testing session. Specifically, the information session consisted&#xD;
      of educating them on and obtaining signatures for informed consent, and conducting health&#xD;
      history and physical activity questionnaire. The first testing session consisted of obtaining&#xD;
      the pre-supplementation DEXA scans. The participants were then given six weeks' worth of&#xD;
      their supplement. The subjects came back to the testing site again at six weeks (midway of&#xD;
      supplementation) to pick up their supplement for the last six weeks and were then instructed&#xD;
      on how to fill out a three-day diet log. The diet log was analyzed and averaged using the&#xD;
      USDA Super Tracker online program. The third and last visit was 12 weeks after the start of&#xD;
      supplementation and during this visit the second set of DEXA scans were obtained and the diet&#xD;
      records were obtained. These records were used to determine the normal diet nutrients as well&#xD;
      as caffeine intake of the participants.&#xD;
&#xD;
      DEXA scanning allows for the measurement of whole body bone density, as well as the specific&#xD;
      density of the hip and femoral head. The subjects were laid on the DEXA machine scanner&#xD;
      motionless for 6-10 minutes while the scan was performed. The first scan measured total body&#xD;
      bone density, as well as the basic body composition. The subject were then asked to lay&#xD;
      motionless for another 6-10 minutes while another DEXA scan was completed, which measured the&#xD;
      bone density and characteristics of the hip and femoral head.The BMD, t-score and z-scores of&#xD;
      the whole body were recorded, as well as the BMD, t-score, and z-scores of the right and left&#xD;
      total hip and femoral necks. These data points were used to determine whether there were any&#xD;
      significant differences between the two groups after the intervention period.&#xD;
&#xD;
      The supplementation of the M. Oleifera was began after the first visit which included the&#xD;
      signing of the consent form, the performance of the pQCT and the DEXA scans. Once the&#xD;
      subjects were scanned they (subjects) were randomly assigned to either the placebo or the M.&#xD;
      Oleifera group. The M. Oleifera group was given the whole leaf M. Oleifera powder in capsule&#xD;
      form at 1000mg daily for 12 weeks and similarly the control group was given the same amount&#xD;
      of cabbage powder in capsule form and route. However, the placebo capsule consisting of&#xD;
      cabbage had significantly lower levels of vitamins and nutrients compared to M. Oleifera. M.&#xD;
      Oleifera was harvested and processed under optimal conditions and was carefully weighed on a&#xD;
      scale and packed into capsules under sterile conditions. Each capsule for both groups&#xD;
      contained 500 mg of the supplement, implying that each participant regardless of their weight&#xD;
      took two capsules daily orally for 12 weeks. If they missed a day they were instructed not to&#xD;
      double the dosage the next day. The placebo group was given the exact same instructions for&#xD;
      consumption as the M. Oleifera group, and the study was conducted in a double blind manner.&#xD;
      The dietary records were collected and analyzed to determine any significant differences&#xD;
      between the two groups based on normal daily consumed nutrients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone Density</measure>
    <time_frame>12 weeks after start of intervention</time_frame>
    <description>Measured by Dual Energy X-Ray Absorptiometry</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Osteoporosis, Osteopenia</condition>
  <condition>Postmenopausal Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Moringa treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Moringa Oleifera was distributed in two 500mg capsules of dried and powdered Moringa Oleifera leaves. Two capsules were taken daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo consisted of dried and powdered cabbage in two 500mg capsules. Two capsules were taken daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Moringa Oleifera</intervention_name>
    <arm_group_label>Moringa treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cabbage Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 60 -70 years old&#xD;
&#xD;
          -  Female&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fracture in non-dominant forearm/wrist or lower leg.&#xD;
&#xD;
          -  Currently taking blood thinners&#xD;
&#xD;
          -  Currently taking estrogen supplements&#xD;
&#xD;
          -  Have had a hysterectomy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Females only</gender_description>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edward K Merritt, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Appalachian State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Appalachian State University</name>
      <address>
        <city>Boone</city>
        <state>North Carolina</state>
        <zip>28608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>17144789</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24096203</PMID>
  </reference>
  <reference>
    <citation>Thurber MD, Fahey JW. Adoption of Moringa oleifera to combat under-nutrition viewed through the lens of the &quot;Diffusion of innovations&quot; theory. Ecol Food Nutr. 2009 May-Jun;48(3):212-25. doi: 10.1080/03670240902794598.</citation>
    <PMID>20161339</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22639499</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24861906</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9814452</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19298195</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Appalachian State University</investigator_affiliation>
    <investigator_full_name>Edward Merritt</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Moringa Oleifera</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Bone Diseases, Metabolic</mesh_term>
    <mesh_term>Osteoporosis, Postmenopausal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03026660
org study id: 15-0257
nct id: NCT03026660
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Moringa Oleifera (M. Oleifera) is a tropical plant native to northern India, Pakistan,
      Himalayan regions, Africa, Central America, and Arabia that has been used for centuries in
      ethnic cultures all over the world. M. Oleifera is exceptionally rich in a variety of
      nutrients and medicinal phytochemicals, including those that promote bone density, such as
      vitamin D, calcium, phosphorus, magnesium and others. M. Oleifera also contains
      micronutrients that play a critical role in bone health and in calcium absorption, such as
      boron, vitamin C, magnesium, potassium, phosphorous and others. For instance, boron
      stabilizes and extends the half-life of vitamin D; magnesium (Mg) affects the activities of
      osteoblasts and osteoclasts, as well as bone homeostasis by modulating the concentration of
      parathormone and the activated form of vitamin D. Magnesium also contributes to bone
      structural development; vitamin K reduces bone turn over, improves bone strength and plays an
      essential role in osteocalcin carboxylation and vitamin C increases bone density and strength
      by increasing collagen formation and promotes healing during fracture. Collectively, these
      micronutrients in M. Oleifera are expected to significantly impact bone health. Given this
      knowledge, the purpose of the present study is to determine the effects of M. Oleifera on the
      structure and function of bone in post-menopausal women ingesting 1 gram of M. Oleifera daily
      for 12 weeks using DEXA scans.

      The fresh young leaves of Moringa oleifera (about 2 years old) were collected by Dr. Joshua
      Idassi, from a field and high tunnel plots at the North Carolina Agriculture and Technical
      State University farm in July, 2014. Botanical identification and authentication were
      performed by Dr. Joshua Idassi, Natural Resources Specialist, from the Cooperative Extension
      Program, North Carolina A & T. A voucher specimen (LUH 2923) was deposited in the herbarium
      of the University of Lagos, Akoka, Yaba, Lagos. Fresh leaves of M. Oleifera were air-dried
      for about 7 days at 30 ◦C and macerated into a fine powder.

      Twenty-four untrained post-menopausal women (60-70 years old) were randomly assigned to
      either the control or placebo group (no program) or the experimental /treatment group (M.
      Oleifera supplement group). Both groups orally ingested 1 gram (1000 mg) daily of cabbage
      (placebo) or M. Oleifera (treatment group) leaf powder in capsules for 12 weeks. The bone
      scans were then taken pre-supplementation and after 12 weeks to determine the effects of M.
      Oleifera on various bone parameters, including bone mass density, bone mineral content, and
      select anthropomorphic results including weight, body fat percentage, and lean mass
      percentage.

      The first visit to the laboratory by participants was utilized for providing them with
      general information and as a testing session. Specifically, the information session consisted
      of educating them on and obtaining signatures for informed consent, and conducting health
      history and physical activity questionnaire. The first testing session consisted of obtaining
      the pre-supplementation DEXA scans. The participants were then given six weeks' worth of
      their supplement. The subjects came back to the testing site again at six weeks (midway of
      supplementation) to pick up their supplement for the last six weeks and were then instructed
      on how to fill out a three-day diet log. The diet log was analyzed and averaged using the
      USDA Super Tracker online program. The third and last visit was 12 weeks after the start of
      supplementation and during this visit the second set of DEXA scans were obtained and the diet
      records were obtained. These records were used to determine the normal diet nutrients as well
      as caffeine intake of the participants.

      DEXA scanning allows for the measurement of whole body bone density, as well as the specific
      density of the hip and femoral head. The subjects were laid on the DEXA machine scanner
      motionless for 6-10 minutes while the scan was performed. The first scan measured total body
      bone density, as well as the basic body composition. The subject were then asked to lay
      motionless for another 6-10 minutes while another DEXA scan was completed, which measured the
      bone density and characteristics of the hip and femoral head.The BMD, t-score and z-scores of
      the whole body were recorded, as well as the BMD, t-score, and z-scores of the right and left
      total hip and femoral necks. These data points were used to determine whether there were any
      significant differences between the two groups after the intervention period.

      The supplementation of the M. Oleifera was began after the first visit which included the
      signing of the consent form, the performance of the pQCT and the DEXA scans. Once the
      subjects were scanned they (subjects) were randomly assigned to either the placebo or the M.
      Oleifera group. The M. Oleifera group was given the whole leaf M. Oleifera powder in capsule
      form at 1000mg daily for 12 weeks and similarly the control group was given the same amount
      of cabbage powder in capsule form and route. However, the placebo capsule consisting of
      cabbage had significantly lower levels of vitamins and nutrients compared to M. Oleifera. M.
      Oleifera was harvested and processed under optimal conditions and was carefully weighed on a
      scale and packed into capsules under sterile conditions. Each capsule for both groups
      contained 500 mg of the supplement, implying that each participant regardless of their weight
      took two capsules daily orally for 12 weeks. If they missed a day they were instructed not to
      double the dosage the next day. The placebo group was given the exact same instructions for
      consumption as the M. Oleifera group, and the study was conducted in a double blind manner.
      The dietary records were collected and analyzed to determine any significant differences
      between the two groups based on normal daily consumed nutrients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Bone Density
time frame: 12 weeks after start of intervention
description: Measured by Dual Energy X-Ray Absorptiometry
arm group label: Moringa treatment
arm group type: Experimental
description: Moringa Oleifera was distributed in two 500mg capsules of dried and powdered Moringa Oleifera leaves. Two capsules were taken daily.
arm group label: Placebo
arm group type: Placebo Comparator
description: The placebo consisted of dried and powdered cabbage in two 500mg capsules. Two capsules were taken daily.
intervention type: Dietary Supplement
intervention name: Moringa Oleifera
arm group label: Moringa treatment
intervention type: Dietary Supplement
intervention name: Cabbage Placebo
arm group label: Placebo
criteria: 
gender: Female
gender based: Yes
gender description: Females only
minimum age: 60 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Edward K Merritt, PhD
role: Principal Investigator
affiliation: Appalachian State University
facility: 
country: United States
citation: 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: 17144789
citation: 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: 24096203
citation: 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: 20161339
citation: 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: 22639499
citation: 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: 24861906
citation: 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: 9814452
citation: 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: 19298195
responsible party type: Principal Investigator
investigator affiliation: Appalachian State University
investigator full name: Edward Merritt
investigator title: Assistant professor
mesh term: Osteoporosis
mesh term: Bone Diseases, Metabolic
mesh term: Osteoporosis, Postmenopausal
sharing ipd: No