AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

01156033818

Egypt1 site, 1 recruiting
  • Faculty of Physical Therapy, Cairo University

    Dokki, Giza Governorate, 12511

    metwally, 01020670619, drsalmaelshafie@gmail.com

    marwa daoud

    Recruiting

Other trials in Egypt

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.

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 groups in NCT05165680
Study groupRoleWhat they receive
experimental group, group AExperimentalThirty 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 dietActive comparatorow 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.

  1. 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)
  1. 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

  2. HB in g/dl

    blood sample analysis

    Measured: 3 months

  3. MCV in fl/cell

    blood sample analysis

    Measured: 3 months

  4. MCH in pg/cell

    blood sample analysis

    Measured: 3 months

  5. MCHC in g/dl

    blood sample analysis

    Measured: 3 months

  6. RDW in %

    blood sample analysis

    Measured: 3 months

  7. WBCs /mm3

    blood sample analysis

    Measured: 3 months

  8. Platelets count /mm3

    blood sample analysis

    Measured: 3 months

  9. 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.

  1. First posted21 Dec 2021
  2. Study start3 Jul 2021
  3. Primary completion1 Feb 2022 (estimated)
  4. Study completion1 Feb 2022 (estimated)

Resources

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)
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

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.

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