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AllergyNCT02525354

Dietary Arachidonic Acid, Obesity and Atopic Respiratory Disease

An observational study of Allergy and Obesity, run by University of New Hampshire.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Epidemiological studies have shown obesity to be a risk factor of asthma. Research evidence of obesity and atopic(ie. allergic)-related respiratory diseases, has been less clear. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Allergy, Obesity
How many people
60 participants
Where
No sites listed yet
Study dates
Oct 2001to May 2003
Phase
Observational
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 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Female subjects were recruited from the University and surrounding local communities, using posted flyers, website announcements, personal announcements in classes, referrals from local physicians, and word of mouth. Prospective subjects were interviewed initially by telephone.

Who may be able to join

  • For asthmatics, only individuals that were willing and capable of not using asthma medications for two days prior to laboratory testing.

Who cannot join

  • An individual was excluded from the study if she had a history of high blood pressure, diabetes, heart disease, cigarette smoking, or eating disorders.
  • Women that were pregnant or lactating.

About this study

Official title: Obesity and Atopic-related Respiratory Disease: Possible Role of Dietary Omega 6 and 3 Fatty Acids

Epidemiological studies have shown obesity to be a risk factor of asthma. Research evidence of obesity and atopic(ie. allergic)-related respiratory diseases, has been less clear. The purpose of the present study was to test the hypothesis that the relationship between obesity and atopic-related respiratory disease in premenopausal women is mediated by a dietary imbalance of omega 6 and 3 polyunsaturated fatty acids.

Read the detailed description

Sixty young adult obese and non obese women, with, and without asthma, were studied using a cross-sectional design. Body composition was measured by plethysmography. A fasted blood sample was taken to measure: specific and total immunoglobulin (IgE) antibodies,biochemical markers of atopy; glucose and insulin to measure insulin sensitivity; estrogen(17β-estradiol) and sex hormone-binding globulin to measure estrogen status of the women; hormone-products of fat tissue ( leptin, adiponectin, resistin, tumor necrosis factor alpha (TNFα), interleukins (IL-6,IL-18), that have been associated with both obesity and immune processes involved in asthma and allergy. Dietary intake of omega 6: linoleic acid (LA), arachidonic acid(AA); and omega 3 fatty acids: α linolenic (ALA), eicosapentanoic (EPA) and docosahexanoic (DHA) and other nutrients were assessed by food frequency questionnaire.

Conditions
Allergy, Obesity
Keywords
arachidonic aci, adiposity, atopy
Medical subject headings
Hypersensitivity, Obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Predictors of serum concentration of specific and total IgE antibodies in obesity

    Measures of insulin sensitivity, plasma concentrations of leptin, adiponectin, , estrogen, IL-18,and dietary arachidonic, eicosapentanoic, docosahexanoic fatty acids were entered as independent variables; and serum concentration of specific and total IgE antibodies as dependent variable, in a forward stepwise multivariate linear regression analysis to identify which factor(s) had the greatest influence on serum concentrations of IgE antibodies in obesity.

    Measured: one day

Secondary outcomes (2)

  1. Relationship between dietary levels of arachidonic, eicosapentanoic, docosahexanoic fatty acids and plasma concentration of leptin in obesity

    Dietary intake of the omega 6 and 3 fatty acids of were analyzed in relation to plasma concentration of leptin in obese and non obese women.

    Measured: one day

  2. Correlation between dietary arachidonic, eicosapentanoic,and docoshexanoic fatty acids and plasma concentration of adiponectin in obesity

    Dietary intake of the omega 6 and 3 fatty acids of were analyzed in relation to plasma concentration of adiponectin in obese and non obese women.

    Measured: one day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2015 (estimated)
  2. Study startOct 2001
  3. Primary completionMay 2003
  4. Study completionMay 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02525354
Sponsor's protocol ID
UNH-01-2536-01
Status last verified
Jul 2015
First submitted
15 Jun 2015
Last updated
17 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • Cordain L, Eaton SB, Sebastian A, Mann N, Lindeberg S, Watkins BA, O'Keefe JH, Brand-Miller J. Origins and evolution of the Western diet: health implications for the 21st century. Am J Clin Nutr. 2005 Feb;81(2):341-54. doi: 10.1093/ajcn.81.2.341.

    PubMed 15699220

  • Linneberg A, Gislum M, Johansen N, Husemoen LL, Jorgensen T. Temporal trends of aeroallergen sensitization over twenty-five years. Clin Exp Allergy. 2007 Aug;37(8):1137-42. doi: 10.1111/j.1365-2222.2007.02760.x.

    PubMed 17651142

  • Holt PG, Macaubas C, Stumbles PA, Sly PD. The role of allergy in the development of asthma. Nature. 1999 Nov 25;402(6760 Suppl):B12-7. doi: 10.1038/35037009.

    PubMed 10586890

  • Beuther DA. Recent insight into obesity and asthma. Curr Opin Pulm Med. 2010 Jan;16(1):64-70. doi: 10.1097/MCP.0b013e3283338fa7.

    PubMed 19844182

  • Ma J, Xiao L, Knowles SB. Obesity, insulin resistance and the prevalence of atopy and asthma in US adults. Allergy. 2010 Nov;65(11):1455-63. doi: 10.1111/j.1398-9995.2010.02402.x.

    PubMed 20456316

  • Chen Y, Rennie D, Cormier Y, Dosman J. Atopy, obesity, and asthma in adults: the Humboldt study. J Agromedicine. 2009;14(2):222-7. doi: 10.1080/10599240902724051.

    PubMed 19437281

  • Husemoen LL, Glumer C, Lau C, Pisinger C, Morch LS, Linneberg A. Association of obesity and insulin resistance with asthma and aeroallergen sensitization. Allergy. 2008 May;63(5):575-82. doi: 10.1111/j.1398-9995.2007.01613.x.

    PubMed 18394132

  • Vieira VJ, Ronan AM, Windt MR, Tagliaferro AR. Elevated atopy in healthy obese women. Am J Clin Nutr. 2005 Sep;82(3):504-9. doi: 10.1093/ajcn.82.3.504.

    PubMed 16155260

  • Ouyang F, Kumar R, Pongracic J, Story RE, Liu X, Wang B, Xing H, Liu X, Li Z, Zhang W, Fang Y, Zhang S, Xu X, Wang X. Adiposity, serum lipid levels, and allergic sensitization in Chinese men and women. J Allergy Clin Immunol. 2009 Apr;123(4):940-8.e10. doi: 10.1016/j.jaci.2008.11.032. Epub 2009 Jan 9.

    PubMed 19135238

  • Kay AB. Allergy and allergic diseases. First of two parts. N Engl J Med. 2001 Jan 4;344(1):30-7. doi: 10.1056/NEJM200101043440106. No abstract available.

    PubMed 11136958

  • Wood JD, Enser M, Richardson RI, Whittington FM. Fatty acids in meat and meat products. 3rd ed. In: Chow CK ed. Fatty acids in food and health complications. Boca Raton, FL: CRC Press, 2008;87-107.

  • Wortman P, Miyazaki Y, Kalupahana NS, Kim S, Hansen-Petrik M, Saxton AM, Claycombe KJ, Voy BH, Whelan J, Moustaid-Moussa N. n3 and n6 polyunsaturated fatty acids differentially modulate prostaglandin E secretion but not markers of lipogenesis in adipocytes. Nutr Metab (Lond). 2009 Jan 21;6:5. doi: 10.1186/1743-7075-6-5.

    PubMed 19159447

  • Decsi T, Molnar D, Koletzko B. Long-chain polyunsaturated fatty acids in plasma lipids of obese children. Lipids. 1996 Mar;31(3):305-11. doi: 10.1007/BF02529877.

    PubMed 8900460

  • Savva SC, Chadjigeorgiou C, Hatzis C, Kyriakakis M, Tsimbinos G, Tornaritis M, Kafatos A. Association of adipose tissue arachidonic acid content with BMI and overweight status in children from Cyprus and Crete. Br J Nutr. 2004 Apr;91(4):643-9. doi: 10.1079/BJN20031084.

    PubMed 15035692

  • Massiera F, Saint-Marc P, Seydoux J, Murata T, Kobayashi T, Narumiya S, Guesnet P, Amri EZ, Negrel R, Ailhaud G. Arachidonic acid and prostacyclin signaling promote adipose tissue development: a human health concern? J Lipid Res. 2003 Feb;44(2):271-9. doi: 10.1194/jlr.M200346-JLR200. Epub 2002 Nov 4.

    PubMed 12576509

Questions about this trial

What is this clinical trial studying?

An observational study of Allergy and Obesity, run by University of New Hampshire.

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 2 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 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Predictors of serum concentration of specific and total IgE antibodies in obesity (time frame: one day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02525354, which also lists 44 linked publications.

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 17 Aug 2015.

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