EAL

MIP: Omega-3

Author and Year:

Hauner H, Much D et al, 2012

PubMed ID:

PMID 22205307

Article Title:

Effect of reducing the n-6:n-3 long-chain PUFA ratio during pregnancy and lactation on infant adipose tissue growth within the first year of life: an open-label randomized controlled trial.

Authors:

Hauner H, Much D, Vollhardt C, Brunner S, Schmid D, Sedlmeier E, Heimberg E, Schuster T, Zimmermann A, Schneider K, Bader B, Amann-Gassner U

Journal:

The American Journal of Clinical Nutrition

Year of publication:

2012

Volume:

Issue:

Page numbers:

383-394.

Study Design:

Randomized Controlled Trial

Risk of Bias Assessment Rating:

Positive

Inclusion Criteria:

Healthy pregnant women at less than 15 weeks gestation. Between 18 and 43 years of age. Pre-pregnancy BMI between 18kg and 30kg/m2. Willingness to implement the dietary recommendations. Sufficient German language skills.

Exclusion Criteria:

High-risk pregnancy (multiple pregnancy, rhesus incompatibility, hepatitis B infection or parity greater than four). Hypertension. Chronic diseases (e.g., diabetes). Gastrointestinal disorders accompanied by maldigestion, malabsorption or elevated energy and nutritional requirements (e.g., gluten enteropathy). Known metabolic defects (e.g., phenylketonuria). Psychiatric diseases. Hyperemesis gravidarum. Supplementation with n-3 LCPUFAs before randomization. Alcohol abuse. Smoking.

Research Purpose:

To examine the effect of a reduction in the n-6 to n-3 LCPUFA ratio in the diet of pregnant women and breastfeeding mothers on adipose tissue growth in their infants up to one year in age, by using two methods of body fat assessment.

Blinding efforts:

The specific intervention of the INFAT study did not allow a double-blind design, however to avoid bias, the number of visits and dietary counseling was the same in both groups. The research staff who assessed the skinfold thickness (primary endpoint) and infant growth was not blinded to study-group allocation. In contrast, the ultrasound measurements were performed by trained pediatricians who were strictly blinded to group allocation and explicitly not involved in any other aspects of the study.

Study Location:

University Hospital Klinikum rechts der Isar, Technische Universitat Munchen, Munich, Germany

Source(s) of Funding:

Government, Industry, Not-for-profit

Please specify names of funders:

Else Kroner-Fresenius Foundation; the International Unilever Foundation; the European Union–funded Early Nutrition Programming Project (EARNEST) consortium; the German Ministry of Education and Research via the Competence Network on Obesity; and Danone Research–Centre for Specialised Nutrition, Friedrichsdorf, Germany.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	Yes
5.	Was blinding used to prevent introduction of bias?		Yes
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	Yes
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	Yes
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	Yes
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	Yes
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	Yes
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes