ObesityHEPNCT01636635
Effect of Age and Weight Loss on Inflammation and Iron Homeostasis
A study testing Calorie Restriction in people with Obesity and Aging, run by Tufts University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of aging and weight loss on iron status and immune response in obese women. Iron deficiency and immune impairment are two of the numerous complications of obesity. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Calorie Restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Nov 2013
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrolling patients in the Weight and Wellness Center (WWC) at Tufts Medical Center, part of their Tufts Employees, low calorie diet (LCD) or pre-surgical low calorie diet (PS-LCD) program, or enrolling at WWC as individual patients.
- BMI in the range of 30 to 55 kg/m2.
- Either ages 18-45 or >60.
Who cannot join
- Pregnancy.
- Weight reduction greater than or equal to 3% in the past 3 months.
- Prior gastric restrictive surgery.
- Weight loss medications within the 4 weeks prior to screening.
- History of eating disorder.
- Renal disease (serum creatinine >2mg/dl).
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- Hepatic disease, except for nonalcoholic steatohepatitis (NASH).
- Celiac disease, or any kind of intestinal malabsorption disorders.
- Gastrointestinal cancer.
- Hereditary hemochromatosis, or any blood disorders.
- Chronic infectious or inflammatory disease.
- Use of immunosuppressants.
- Severe iron deficiency anemia (hemoglobin<8 g/dl) or other conditions that would prevent them from discontinuing iron supplement use.
- Unwilling to discontinue iron supplement intake. The dietary plan recommended by the WWC will include daily intake of iron that meets the iron RDA for the subject's gender and age group, therefore discontinuing iron supplement will not be harmful for the participants. Intake of other supplements will not be an exclusion criteria, as long as it stays constant throughout the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
JM USDA Human Nutrition Research Center on Aging
Boston, Massachusetts, 02111
About this study
Official title: Effect of Age and Weight Loss on Obesity-related Inflammation and Iron Homeostasis in Women
The purpose of this study is to evaluate the effect of aging and weight loss on iron status and immune response in obese women. Iron deficiency and immune impairment are two of the numerous complications of obesity. The central hypothesis is that obesity-induced inflammation causes lower iron status through decreased iron absorption and availability in young and older obese women. Furthermore, the investigators hypothesize that this can be corrected with weight loss in both young and older obese women.
Read the detailed description
Obese individuals have chronic inflammation, higher risk of iron deficiency, and impaired immune response. These are conditions seen also with aging, but it is unknown to what extent they may be further impacted by obesity in the elderly. With this study the investigators aim to establish the mechanism by which weight loss may reduce inflammation and enhance iron status in young and older obese adults through the peptide hormone hepcidin, which regulates iron homeostasis. The investigators also aim to identify a possible link between iron homeostasis and immune response through hepcidin, which has been implicated in T cell mediated immunity. The investigators hypothesize that obesity-induced inflammation causes dysregulation of hepcidin expression leading to lower iron status through decreased iron absorption and availability in young and older adults. Furthermore, the investigators hypothesize that hepcidin dysregulation, and thus iron status can be mitigated with weight loss in both young and older obese adults. This hypothesis will be tested in obese young and older women undergoing weight loss through calorie restriction. Change in iron status, inflammation, and hepcidin will be determined before and after weight loss. Further, the impact of inflammatory environment of obesity on peripheral blood mononuclear cell hepcidin, ferroportin, intracellular iron, and T cell function in young and older adults will be determined. This study will address two important public health problems, i.e. obesity and iron deficiency and will be an important step toward the identification of strategies to enhance health of obese young and older adults.
- Being tested
- Calorie Restriction
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie RestrictionOther
Intervention consists of a calorically restricted diet regime designed and administered at the Weight and Wellness Center at Tufts University
| Study group | Role | What they receive |
|---|---|---|
| Young (18-45 years) | Active comparator | Obese young women (18-45y) undergoing calorie restriction. Receives: Other: Calorie Restriction |
| Older (>60 years) | Experimental | Obese older women (>60y) undergoing calorie restriction. Receives: Other: Calorie Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum hepcidin
The investigators will determine the change in hepcidin at baseline and after 12-16 weeks of calorie restriction.
Measured: Baseline and 12-16 weeks
Change in inflammation (CRP, IL-6)
The investigators will determine the change in inflammation at baseline and after 12-16 weeks of calorie restriction.
Measured: Baseline and 12-16 weeks
Change in iron status
The investigators will determine the change in iron status at baseline and after 12-16 weeks of calorie restriction.
Measured: Baseline and 12-16 weeks
Secondary outcomes (4)
Change in PBMC intracellular iron content
Measured: Baseline and 12-16 weeks
Change in PBMC Hepcidin expression
Measured: Baseline and 12-16 weeks
Change in PBMC ferroportin expression
Measured: Baseline and 12-16 weeks
Change in PBMC subpopulations and proliferation
After stimulation with ConA, PHA and anti-CD3/CD28
Measured: Baseline and 12-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startMar 2011
- Primary completionNov 2013
- Study completionNov 2013
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.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simin Meydani, Tufts University
- Investigators
- Simin N Meydani, DVM, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636635
- Sponsor's protocol ID
- 2765
- Acronym
- HEP
- Status last verified
- Nov 2015
- First submitted
- 26 Jan 2012
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Age and Weight Loss on Obesity-related Inflammation and Iron Homeostasis in Women
- ClinicalTrials.gov ID
- NCT01636635
- Acronym / sponsor ID
- HEP / 2765
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Jul 2012 (estimated)
- 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.
The purpose of this study is to evaluate the effect of aging and weight loss on iron status and immune response in obese women. Iron deficiency and immune impairment are two of the numerous complications of obesity. The central hypothesis is that obesity-induced inflammation causes lower iron status through decreased iron absorption and availability in young and older obese women. Furthermore, the investigators hypothesize that this can be corrected with weight loss in both young and older obese women.
Detailed description
Obese individuals have chronic inflammation, higher risk of iron deficiency, and impaired immune response. These are conditions seen also with aging, but it is unknown to what extent they may be further impacted by obesity in the elderly. With this study the investigators aim to establish the mechanism by which weight loss may reduce inflammation and enhance iron status in young and older obese adults through the peptide hormone hepcidin, which regulates iron homeostasis. The investigators also aim to identify a possible link between iron homeostasis and immune response through hepcidin, which has been implicated in T cell mediated immunity. The investigators hypothesize that obesity-induced inflammation causes dysregulation of hepcidin expression leading to lower iron status through decreased iron absorption and availability in young and older adults. Furthermore, the investigators hypothesize that hepcidin dysregulation, and thus iron status can be mitigated with weight loss in both young and older obese adults. This hypothesis will be tested in obese young and older women undergoing weight loss through calorie restriction. Change in iron status, inflammation, and hepcidin will be determined before and after weight loss. Further, the impact of inflammatory environment of obesity on peripheral blood mononuclear cell hepcidin, ferroportin, intracellular iron, and T cell function in young and older adults will be determined. This study will address two important public health problems, i.e. obesity and iron deficiency and will be an important step toward the identification of strategies to enhance health of obese young and older adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young (18-45 years) | Active comparator | Other: Calorie RestrictionObese young women (18-45y) undergoing calorie restriction. |
| Older (>60 years) | Experimental | Other: Calorie RestrictionObese older women (>60y) undergoing calorie restriction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Enrolling patients in the Weight and Wellness Center (WWC) at Tufts Medical Center, part of their Tufts Employees, low calorie diet (LCD) or pre-surgical low calorie diet (PS-LCD) program, or enrolling at WWC as individual patients.
- BMI in the range of 30 to 55 kg/m2.
- Either ages 18-45 or >60.
Key exclusion criteria (14 listed)
- Pregnancy.
- Weight reduction greater than or equal to 3% in the past 3 months.
- Prior gastric restrictive surgery.
- Weight loss medications within the 4 weeks prior to screening.
- History of eating disorder.
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 |
|---|---|---|
| Calorie RestrictionIntervention consists of a calorically restricted diet regime designed and administered at the Weight and Wellness Center at Tufts University | Other | Older (>60 years), Young (18-45 years) |
Primary outcome
Change in serum hepcidin
Time frame: Baseline and 12-16 weeks
The investigators will determine the change in hepcidin at baseline and after 12-16 weeks of calorie restriction.
Change in inflammation (CRP, IL-6)
Time frame: Baseline and 12-16 weeks
The investigators will determine the change in inflammation at baseline and after 12-16 weeks of calorie restriction.
Change in iron status
Time frame: Baseline and 12-16 weeks
The investigators will determine the change in iron status at baseline and after 12-16 weeks of calorie restriction.
4 secondary outcomes
Change in PBMC intracellular iron content
Time frame: Baseline and 12-16 weeks
Change in PBMC Hepcidin expression
Time frame: Baseline and 12-16 weeks
Change in PBMC ferroportin expression
Time frame: Baseline and 12-16 weeks
Change in PBMC subpopulations and proliferation
Time frame: Baseline and 12-16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
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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.
Simin N Meydani, DVM, PhD principal investigator
Tufts 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 Calorie Restriction in people with Obesity and Aging, run by Tufts University at 1 site in United States.
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 3 inclusion and 14 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: finished, as of the sponsor's last update on 16 Nov 2015. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum hepcidin (time frame: Baseline and 12-16 weeks). The study lists 3 primary outcomes in all. 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 16 Nov 2015.