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Study Title and Description

Effects of a rapeseed oil-enriched hypoenergetic diet with a high content of α-linolenic acid on body weight and cardiovascular risk profile in patients with the metabolic syndrome.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effects of a rapeseed oil-enriched hypoenergetic diet with a high content of α-linolenic acid on body weight and cardiovascular risk profile in patients with the metabolic syndrome.
Author Baxheinrich A., Stratmann B., Lee-Barkey YH., Tschoepe D., Wahrburg U.
Country Department of Nutritional Science, University of Applied Sciences, Muenster, Germany. baxheinrich@fh-muenster.de
Year 2012
Numbers Pubmed ID: 22894911
15598 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 ALA rapeseed oil
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2 Placebo Olive oil
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Parallel (Omega-3 vs. Control; Omega-3 + X vs. X)
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Country in which study conducted (where subjects live) Germany
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Funding source Industry funded
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Eligibility Criteria: To be enrolled in the study, subjects had to meet the diagnosis criteria, grains). Thus, it is an important exception from other high- fat diets, which tend to have a high energy density. Despite a total fat content of up to 35–40 % of energy (En%), the Med-iterranean diet is characterised by a low ED, which facilitates an energy-restricted diet, and leads to a significant weight loss. Simultaneously, beneficial effects on serum lipid and glucose levels are observed. Thus, this kind of MUFA-rich diet may be a suitable alternative to low-fat diets. When searching for the optimal dietary regimen, specific food components which may further improve the metabolic risk profile should also be considered. In particular, there is evidence for various protective effects of n-3 fatty acids. These include reduction of serum TAG concentrations, improved insulin sensitivity and decreased blood pressure. However, these effects have only been shown for the long-chain marine n-3 fatty acids EPA and DHA. It is largely unknown whether the plant-derived a-linolenic acid (ALA) has a significant preventive potential, too. Possible cardioprotective and anti-inflammatory benefits have recently been reviewed. The effects were described for supplements or flaxseed oil as ALA source. et al. (27) , for example, found a significant reduction in blood pressure after the intake of 8 g ALA/d from flaxseed oil. For dietary practice, it is of special interest whether protec- tive effects of ALA can be achieved without supplements but with amounts found in a long-term natural food diet. While a low-fat dietary approach only offers a scarce margin for the intake of vegetable oils as the natural source of ALA, the above-described MUFA-rich dietary pattern provides a suitable option for larger daily amounts of an added vegetable oil. Rapeseed oil is a vegetable oil that provides both a high pro- portion of MUFA and, simultaneously, about 10 % of ALA. In the present study, the effects of a rapeseed oil-enriched hypoenergeticdietwithalowEDwereinvestigatedduringa 6-month weight reduction programme in patients with the meta- bolic syndrome. To identify the specific effects of ALA, the rape- seed oil diet was compared with a control diet rich in olive oil which had a similar MUFA content to ensure that the ALA intake was the only difference between the two dietary approaches. Methods Participants For the present study, a total of 178 interested persons were recruited by advertisement in the local newspaper. To be enrolled in the study, subjects had to meet the diagnosis criteria of the metabolic syndrome according to the definition of the International Diabetes Federation (Table 1) (30) . Exclusion cri- teria were CVD, severe illnesses such as renal failure or liver disease, food allergy or intolerance, pregnancy or lactation, smoking, alcohol abuse and insulin therapy or severe diabetic complications in case of diagnosed type 2 diabetes mellitus.
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Study Population Primary Prevention, Increased CVD Risk (ie, diabetes, metabolic syndrome*, hypertension, dyslipidemia, or chronic kidney disease)
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Duration of Intervention 6 months
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At baseline, did all subjects have (per eligibility criteria)...? Diabetes and/or metabolic syndrome*
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Conflict of interest No conflict of interest (explicitly stated)
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Does the study report a subgroup analysis for an outcome of interest? No
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Does the study report a regression analysis with interaction terms for an outcome of interest? ... Which predictors/variables? Yes ... time
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Does the study report an analysis of the association between n-3 biomarkers and an outcome of interest? No
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Study start date(s) 2010 (approx)
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Baseline Characteristics
Question ALA Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 100 100
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Baseline characteristics, continuous 52.3 50.3 nd
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skip skip nd
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10.6 9.8 nd
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142.4 140.1 nd
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skip skip nd
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18.6 12.4 nd
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91.8 90.2 nd
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skip skip nd
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11.8 7.7 nd
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5.43 nd nd
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mmol/L 5.49
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0.88 mmol/L
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3.42 1.09
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mmol/L 3.49
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0.82 mmol/L
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1.37 0.92
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mmol/L 1.43
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0.29 mmol/L
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1.94 0.34
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mmol/L 1.64
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1.13 mmol/L
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33.4 1.02
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skip 35.2
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4.8 skip
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97.3 5.1
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Kg 99.4
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19.7 Kg
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nd 16.2
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Male, percent nd nd
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Race nd nd nd
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Comments about baseline data No data entered.
Baseline diet description Energy intake and nutrient composition of the diets at baseline and during the intervention period is given in Table 3. Energy intake and nutrient composition of the diets at baseline and during the intervention period is given in Table 3.
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Baseline omega-3 intake nd nd
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Does this study report baseline omega-3 biomarker data? No No No
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Results & Comparisons


Results Data
Outcome: bp      Population: 45675
Time Point Measure ALA Placebo


0 months

N Analyzed 40 41
Mean 142.4 140.1
SD 18.6 12.4


3 months

N Analyzed 40 41
Mean 134.1 131.5
SD 18.4 12.3


6 months

N Analyzed 40 41
Mean 132.5 132
SD 16.2 11.4
Outcome: bp      Population: 45676
Time Point Measure ALA Placebo


0 months

N Analyzed 40 41
Mean 91.8 90.2
SD 11.8 7.7


3 months

N Analyzed 40 41
Mean 84.3 87
SD 11.4 9


6 months

N Analyzed 40 41
Mean 83.4 85.7
SD 9.8 8.7
Outcome: lipid      Population: 45677
Time Point Measure ALA Placebo


0 months

N Analyzed 40 41
Mean 3.42 3.49
SD 0.82 0.92


3 months

N Analyzed 40 41
Mean 3.01 3.23
SD 0.73 0.73


6 months

N Analyzed 40 41
Mean 3.2 3.22
SD 0.81 0.72
Outcome: lipid      Population: 45678
Time Point Measure ALA Placebo


0 months

N Analyzed 40 41
Mean 1.37 1.43
SD 0.29 0.34


3 months

N Analyzed 40 41
Mean 1.30 1.31
SD 0.29 0.26


6 months

N Analyzed 40 41
Mean 1.40 1.40
SD 0.31 0.31
Outcome: lipid      Population: 45679
Time Point Measure ALA Placebo


0 months

N Analyzed 40 41
Mean 1.94 1.64
SD 1.13 1.02


3 months

N Analyzed 40 41
Mean 1.62 1.59
SD 1.34 1.08


6 months

N Analyzed 40 41
Mean 1.49 1.44
SD 0.79 0.71

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? No Data randomization method not mentioned.
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Was ALLOCATION adequately concealed (prior to assignment)? No Data No concealing is mentioned
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Were PARTICIPANTS adequately BLINDED? No Data No blinding is mentioned
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Were OUTCOME ASSESSORS adequately BLINDED? Unsure
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data No
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
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INTENTION-TO-TREAT analysis? (Yes/No) No Data
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Group SIMILARITY AT BASELINE (**GENERAL**) Yes
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Was there incomplete COMPLIANCE with interventions across groups? No
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Group SIMILARITY AT BASELINE (**OMEGA-3**) No Data
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Additional Bias: Bias due to problems not covered elsewhere in the table.
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If outcome assessor blinding risk of bias is different for different outcomes (eg, lipids vs. MI), choose HIGH risk of bias and describe in Notes Unsure lab tests are for lipids but not blood pressure
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If attrition risk of bias is different for different outcomes (eg, lipids vs. MI) or different time points (eg, 1 year vs. 5 years), choose HIGH risk of bias and describe in Notes
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Quality Rating
No quality rating data was found.