ObesityNCT05165680
Effect of Aerobic Exercise and Diet on Anthropometric and Hematological Measurements in Obese Anemic Women
A study testing combination of aerobic exercise and healthy diet in people with Obesity and Iron Deficiency Anemia, run by Cairo University at 1 site in Egypt.
Trial summary
Obesity and iron deficiency (ID) are two forms of the most usual nutritional disorders worldwide. Iron deficiency remains the most common nutritional deficiency and cause of anemia worldwide. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Obesity, Iron Deficiency Anemia
- What is being tested?
- combination of aerobic exercise and healthy diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Age will ranges from 30 to 40 years. 2. BMI will ranges from 30 to 34.9 kg/m2 3. Hemoglobin level will ranges from 8 to 11 g/dl. 4. All of participants suffer from iron deficiency anemia. 5. Same level of physical activity according to physical activity index. 6. Same level of education and income.
Who cannot join
- 1. Cognitive impairment that prevents participants from performing the evaluations and who are unable to understand and sign the written informed consent.
- 2. Hypertension. 3. diabetes mellitus 4. Disabling musculoskeletal disorder. 5. Patients with coronary artery disease or heart failure 6. Peripheral vascular disease in lower limb as deep venous thrombosis. 7. Stroke and bone disease, renal, liver, endocrinal disorders, cancer, or chemotherapy.
- 8. Different types of anemia. 9. Worms' affection. 10. Pregnancy and lactation. 11. Vitamins deficiency. 12. Six months post large surgeries.
Trial locations and contacts
1 site in 1 country.
marwa daoud, master contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Cairo University
Dokki, Giza Governorate, 12511
metwally, 01020670619, drsalmaelshafie@gmail.com
marwa daoud
About this study
Obesity and iron deficiency (ID) are two forms of the most usual nutritional disorders worldwide. Iron deficiency remains the most common nutritional deficiency and cause of anemia worldwide. Populations in the developing countries, premenopausal females, pregnant women, children, vegetarians and frequent blood donors are largely affected by iron deficiency due to low dietary intake, inadequate bioavailable iron, increased iron demand required for growth and development, iron losses and changes in blood volume. WHO recognized obesity as disease, which is prevalent in both developing and developed countries. Overweight and obesity are now so common and thereby replacing the more traditional public health concerns (under nutrition and infectious diseases) as some of most significant contributors to ill health.
The aim of this study is to investigate effect of aerobic exercise and diet on obese anemic premenopausal women which not clarified previously.
Read more
It will be hypothesized that:
There will be no significant effect of aerobic exercise and diet on the anthropometric and hematological measurements in obese anemic women.
Read the detailed description
Low level of serum iron was observed with weight gain and increasing BMI, both iron deficiency and obesity are worldwide epidemics affecting billions with regional variation.
Iron-deficiency anemia has a substantial effect on the lives of premenopausal women in both low-income and developed countries. A low level of iron, leading to anemia, can result from various causes. The causes of iron-deficiency anemia are pregnancy or childhood growth spurts, Heavy menstrual periods. Iron-deficiency anemia is chronic and frequently asymptomatic and thus may often go undiagnosed. Symptoms include tiredness, lethargy, feeling faint and becoming breathless easily, headaches, irregular heartbeats (palpitations), altered taste, sore mouth and ringing in the ears (tinnitus). Anemia in pregnancy increases the risk of complications in both mother and baby such as low birth weight baby, preterm (premature) delivery and postnatal depression. Low iron reserves in the baby may also lead to anemia in the newborn baby.
Several factors may explain why greater adiposity increases risk for anemia. However, even if diets of overweight individuals are not lower in iron, the absorption of the iron may be reduced because increased circulating hepcidin (a 25-amino-acid peptide hormone with a key role in body iron regulation, is produced mainly by the liver but also, possibly, by adipose tissue in obesity may reduce iron absorption, Iron requirements in overweight individuals may be increased due to larger blood volume and higher basal iron losses with higher body weight. women suggest greater adiposity is associated with lower fractional iron absorption in humans.
Exercise training can increase total Hb and red cell mass, which enhances oxygen-carrying capacity. The possible underlying mechanisms are proposed to come mainly from bone marrow, including stimulated erythropoiesis with hyperplasia of the hematopoietic bone marrow, improvement of the hematopoietic microenvironment induced by exercise training, and hormone- and cytokine-accelerated erythropoiesis. The effects of exercise training on counteracting anemia have been explored and evaluated. The results of the research available to date are controversial, and it seems that significant methodological limitations exist. However, exercise training might be a promising, additional, safe and economical method to help improve anemia. There is a need for further investigation into the effects of and guidelines for exercise interventions in this population of patients.
Largely, the prevailing evidence suggests that a healthy mode of weight loss in obese subjects is accompanied by an improvement of inflammatory markers along with re-established dietary iron absorption and serum iron concentrations as an indication for re-establishment of physiological iron homeostasis. Treating anemia is a matter of how much food we eat that aid in hemoglobin synthesis. In general, to treat anemia, focus should be placed on foods that are good sources of iron, copper, zinc, folic acid, Vitamin B-12, protein, fruits, vegetables, meat, honey, legumes and nuts.
Sixty anemic obese premenopausal women participants, their ages will range from 30 to 40 years. The participants will be selected from General Zagazig Hospital. All participants will be randomly assigned into two groups equal in number; Experimental group and control group. Experimental group will receive a program of aerobic exercise, low caloric diet rich in iron, vitamin c, and folate for 3 times per week and Iron supplements for 12 weeks , while control group will only receive low caloric diet rich in iron, vitamin c, and folate for 3 times per week and Iron supplements for 12 weeks . Participants' demographic data will be collected as marital status, length of menstrual cycle, level of income, level of education, occupation.
- Conditions
- Obesity, Iron Deficiency Anemia
- Being tested
- combination of aerobic exercise and healthy diet
- Medical subject headings
- Obesity, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of aerobic exercise and healthy dietCombination product
The 30 patients in this group will receive iron supplements, a personalized low caloric diet therapy based on Harris-Benedict equation. A restricted balanced diet will be prescribed which will be included. Perform aerobic exercise in the form of walking on electrical treadmill three times/ week day after day for 12 weeks according to following parameters.
- Type: moderate treadmill aerobic exercise
- Time: 40 minutes (5 minutes warm up phase, 30 minutes target heart rate (THR) phase, 5 minutes cooling down phase)
- Intensity: THR will be at 75% of maximum heart rate (which will be determined by submaximal graded exercise test and predicated MHR=220-age)
- Frequency: three times per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| experimental group, group A | Experimental | Thirty patients in this group will perform aerobic exercise in the form of walking on electric treadmill three times/ week day after day and low caloric diet rich in iron, vitamin C and folate and iron supplement for 12 weeks. Receives: Combination Product: combination of aerobic exercise and healthy diet |
| healthy diet | Active comparator | ow caloric diet rich in iron, vitamin C and folate and iron supplement for 12 weeks. Receives: Combination Product: combination of aerobic exercise and healthy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI in kg/m2
The anthropometric measurements will be detected via the in body scale. BMI (kg/m2) will be measured for all participants by dividing each participant's body weight (kg) by their heights (m2). Further, WC will be estimated during full expiration using an elastic tape midway between the last rib and the upper iliac crest border.
Measured: 3 months
Secondary outcomes (9)
RBCs in cells/ml
Blood sample analysis to show the hematological measurements level, each participant will be asked to lie in half- lying position, with well supported back and arms. The antecubital area will be cleaned with alcohol. Blood sample will be drawn from the brachial vein from all participants by disposable sterile syringe.
Measured: 3 months
HB in g/dl
blood sample analysis
Measured: 3 months
MCV in fl/cell
blood sample analysis
Measured: 3 months
MCH in pg/cell
blood sample analysis
Measured: 3 months
MCHC in g/dl
blood sample analysis
Measured: 3 months
RDW in %
blood sample analysis
Measured: 3 months
WBCs /mm3
blood sample analysis
Measured: 3 months
Platelets count /mm3
blood sample analysis
Measured: 3 months
serum ferritin in ng/ml
blood sample analysis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start3 Jul 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixty anemic obese premenopausal women, their ages will range from 30 to 40 years. The participants will be selected from General Zagazig Hospital. All participants will be randomly assigned into two groups equal in number; Experimental group and control group. Experimental group will receive a program of aerobic exercise, low caloric diet rich in iron, vitamin c, and folate for 3 times per week and Iron supplements for 12 weeks , while control group will only receive low caloric diet rich in iron, vitamin c, and folate for 3 times per week and Iron supplements for 12 weeks . Participants' demographic data will be collected as marital status, length of menstrual cycle, level of income, level of education, occupation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Nabil Fathy Ahmed, Cairo University
- Investigators
- gehan elmeniawy, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165680
- Sponsor's protocol ID
- P.T.REC/012/003337
- Status last verified
- Dec 2021
- First submitted
- 7 Nov 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sharing study protocols with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise and Diet on Anthropometric and Hematological Measurements in Obese Anemic Women
- ClinicalTrials.gov ID
- NCT05165680
- Acronym / sponsor ID
- P.T.REC/012/003337
- Conditions
- Obesity, Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jul 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity and iron deficiency (ID) are two forms of the most usual nutritional disorders worldwide. Iron deficiency remains the most common nutritional deficiency and cause of anemia worldwide. Populations in the developing countries, premenopausal females, pregnant women, children, vegetarians and frequent blood donors are largely affected by iron deficiency due to low dietary intake, inadequate bioavailable iron, increased iron demand required for growth and development, iron losses and changes in blood volume. WHO recognized obesity as disease, which is prevalent in both developing and developed countries. Overweight and obesity are now so common and thereby replacing the more traditional public health concerns (under nutrition and infectious diseases) as some of most significant contributors to ill health.
The aim of this study is to investigate effect of aerobic exercise and diet on obese anemic premenopausal women which not clarified previously.
It will be hypothesized that:
There will be no significant effect of aerobic exercise and diet on the anthropometric and hematological measurements in obese anemic women.
Detailed description
Low level of serum iron was observed with weight gain and increasing BMI, both iron deficiency and obesity are worldwide epidemics affecting billions with regional variation.
Iron-deficiency anemia has a substantial effect on the lives of premenopausal women in both low-income and developed countries. A low level of iron, leading to anemia, can result from various causes. The causes of iron-deficiency anemia are pregnancy or childhood growth spurts, Heavy menstrual periods. Iron-deficiency anemia is chronic and frequently asymptomatic and thus may often go undiagnosed. Symptoms include tiredness, lethargy, feeling faint and becoming breathless easily, headaches, irregular heartbeats (palpitations), altered taste, sore mouth and ringing in the ears (tinnitus). Anemia in pregnancy increases the risk of complications in both mother and baby such as low birth weight baby, preterm (premature) delivery and postnatal depression. Low iron reserves in the baby may also lead to anemia in the newborn baby.
Several factors may explain why greater adiposity increases risk for anemia. However, even if diets of overweight individuals are not lower in iron, the absorption of the iron may be reduced because increased circulating hepcidin (a 25-amino-acid peptide hormone with a key role in body iron regulation, is produced mainly by the liver but also, possibly, by adipose tissue in obesity may reduce iron absorption, Iron requirements in overweight individuals may be increased due to larger blood volume and higher basal iron losses with higher body weight. women suggest greater adiposity is associated with lower fractional iron absorption in humans.
Exercise training can increase total Hb and red cell mass, which enhances oxygen-carrying capacity. The possible underlying mechanisms are proposed to come mainly from bone marrow, including stimulated erythropoiesis with hyperplasia of the hematopoietic bone marrow, improvement of the hematopoietic microenvironment induced by exercise training, and hormone- and cytokine-accelerated erythropoiesis. The effects of exercise training on counteracting anemia have been explored and evaluated. The results of the research available to date are controversial, and it seems that significant methodological limitations exist. However, exercise training might be a promising, additional, safe and economical method to help improve anemia. There is a need for further investigation into the effects of and guidelines for exercise interventions in this population of patients.
Largely, the prevailing evidence suggests that a healthy mode of weight loss in obese subjects is accompanied by an improvement of inflammatory markers along with re-established dietary iron absorption and serum iron concentrations as an indication for re-establishment of physiological iron homeostasis. Treating anemia is a matter of how much food we eat that aid in hemoglobin synthesis. In general, to treat anemia, focus should be placed on foods that are good sources of iron, copper, zinc, folic acid, Vitamin B-12, protein, fruits, vegetables, meat, honey, legumes and nuts.
Sixty anemic obese premenopausal women participants, their ages will range from 30 to 40 years. The participants will be selected from General Zagazig Hospital. All participants will be randomly assigned into two groups equal in number; Experimental group and control group. Experimental group will receive a program of aerobic exercise, low caloric diet rich in iron, vitamin c, and folate for 3 times per week and Iron supplements for 12 weeks , while control group will only receive low caloric diet rich in iron, vitamin c, and folate for 3 times per week and Iron supplements for 12 weeks . Participants' demographic data will be collected as marital status, length of menstrual cycle, level of income, level of education, occupation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Sixty anemic obese premenopausal women, their ages will range from 30 to 40 years. The participants will be selected from General Zagazig Hospital. All participants will be randomly assigned into two groups equal in number; Experimental group and control group. Experimental group will receive a program of aerobic exercise, low caloric diet rich in iron, vitamin c, and folate for 3 times per week and Iron supplements for 12 weeks , while control group will only receive low caloric diet rich in iron, vitamin c, and folate for 3 times per week and Iron supplements for 12 weeks . Participants' demographic data will be collected as marital status, length of menstrual cycle, level of income, level of education, occupation.
| Arm | Type | Receives |
|---|---|---|
| experimental group, group A | Experimental | Combination Product: combination of aerobic exercise and healthy dietThirty patients in this group will perform aerobic exercise in the form of walking on electric treadmill three times/ week day after day and low caloric diet rich in iron, vitamin C and folate and iron supplement for 12 weeks. |
| healthy diet | Active comparator | Combination Product: combination of aerobic exercise and healthy dietow caloric diet rich in iron, vitamin C and folate and iron supplement for 12 weeks. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Age will ranges from 30 to 40 years. 2. BMI will ranges from 30 to 34.9 kg/m2 3. Hemoglobin level will ranges from 8 to 11 g/dl. 4. All of participants suffer from iron deficiency anemia. 5. Same level of physical activity according to physical activity index. 6. Same level of education and income.
Key exclusion criteria (3 listed)
- 1. Cognitive impairment that prevents participants from performing the evaluations and who are unable to understand and sign the written informed consent.
- 2. Hypertension. 3. diabetes mellitus 4. Disabling musculoskeletal disorder. 5. Patients with coronary artery disease or heart failure 6. Peripheral vascular disease in lower limb as deep venous thrombosis. 7. Stroke and bone disease, renal, liver, endocrinal disorders, cancer, or chemotherapy.
- 8. Different types of anemia. 9. Worms' affection. 10. Pregnancy and lactation. 11. Vitamins deficiency. 12. Six months post large surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combination of aerobic exercise and healthy dietThe 30 patients in this group will receive iron supplements, a personalized low caloric diet therapy based on Harris-Benedict equation. A restricted balanced diet will be prescribed which will be included. Perform aerobic exercise in the form of walking on electrical treadmill three times/ week day after day for 12 weeks according to following parameters. * Type: moderate treadmill aerobic exercise * Time: 40 minutes (5 minutes warm up phase, 30 minutes target heart rate (THR) phase, 5 minutes cooling down phase) * Intensity: THR will be at 75% of maximum heart rate (which will be determined by submaximal graded exercise test and predicated MHR=220-age) * Frequency: three times per week for 12 weeks | Combination product | experimental group, group A, healthy diet |
Primary outcome
BMI in kg/m2
Time frame: 3 months
The anthropometric measurements will be detected via the in body scale. BMI (kg/m2) will be measured for all participants by dividing each participant's body weight (kg) by their heights (m2). Further, WC will be estimated during full expiration using an elastic tape midway between the last rib and the upper iliac crest border.
9 secondary outcomes
RBCs in cells/ml
Time frame: 3 months
HB in g/dl
Time frame: 3 months
MCV in fl/cell
Time frame: 3 months
MCH in pg/cell
Time frame: 3 months
MCHC in g/dl
Time frame: 3 months
RDW in %
Time frame: 3 months
WBCs /mm3
Time frame: 3 months
Platelets count /mm3
Time frame: 3 months
serum ferritin in ng/ml
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: Yes. sharing study protocols with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
marwa daoud, master contact
gehan elmeniawy study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination of aerobic exercise and healthy diet in people with Obesity and Iron Deficiency Anemia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact metwally (01020670619, drsalmaelshafie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI in kg/m2 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.