Clinical trial NCT01527253: Effect of a Synergistic Food Basket on Metabolic Syndrome Risk
Official title: Effects of a Synergistic Food Basket on Markers of Metabolic Syndrome Risk in Healthy Mature Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Insulin Resistance
Keywords: Cardiometabolic risk
Metabolic syndrome
Prebiotics
Legumes
Wholegrain cereal
Functional diet
Low glycemic index diet
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Anti-Diabetic Food Centre
First posted: 2012-02-06
Enrollment: 52
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study evaluates the effect of a diet combining two different functional concepts on markers associated to cardiometabolic risk. The functional concepts are selected on the basis of their reported ability to influence the inflammatory tonus. It is hypothesized that the medium-term consumption of a diet combining low GI-prebiotic foods may positively influence various biomarkers associated with the risk for developing metabolic syndrome and cardiometabolic disease. Also, the combination of functional mechanisms are expected to result in synergistic effects.

Detailed description: The intervention is carried out in healthy women following a randomized crossover design in which an "active" (functional") diet is compared with a control diet formulated in agreement with the Nordic Dietary Recommendations but lacking the functional ingredients of the active regime.

The active diet supplies important daily amounts of dried legumes and wholegrain cereal products.

Each dietary treatment is applied for 4 weeks separated by a 4-6 week washout period. Subjects are encouraged to maintain a stable body weight under the whole trial.

Eligibility criteria: Inclusion Criteria:

* BMI between 25 and 32 kg/m2

Exclusion Criteria:

* Fasting blood glucose \> 6.1 mmol/L
* Medication for high blood pressure and/or elevated blood cholesterol

Primary outcomes:
measure: Change from baseline in LDL cholesterol after each dietary period
timeFrame: Week 0 and after 4 weeks (Start and End of the intervention arm)
Secondary outcomes:
measure: Change from baseline in LDL-cholesterol/HDL-cholesterol after each dietary period
timeFrame: Week 0 and after 4 weeks (Start and End of the intervention arm)
measure: Change from baseline in fasting plasma triglycerides after each dietary period
timeFrame: Week 0 and after 4 weeks (Start and End of the intervention arm)
measure: Change from baseline in fasting CRP after each dietary period
timeFrame: Week 0 and after 4 weeks (Start and End of the intervention arm)
measure: Change from baseline in fasting plasma PYY after each dietary period
timeFrame: Week 0 and after 4 weeks (Start and End of the intervention arm)
measure: Change from baseline in fasting plasma insulin after each dietary period
timeFrame: Week 0 and after 4 weeks (Start and End of the intervention arm)
measure: Change from baseline in fasting plasma glucose after each dietary period
timeFrame: Week 0 and after 4 weeks (Start and End of the intervention arm)
measure: Change from baseline in fasting plasma PAI-1 after each dietary period
timeFrame: Week 0 and after 4 weeks (Start and End of the intervention arm)
measure: Change from baseline in BMI after each dietary period
timeFrame: Week 0 and after 4 weeks (Start and End of the intervention arm)
measure: Change from baseline in blood pressure after each dietary period
timeFrame: Week 0 and after 4 weeks (Start and End of the intervention arm)
measure: Change from baseline in HOMA-IR after each dietary period
timeFrame: Week 0 and after 4 weeks (Start and End of the intervention arm)
measure: Change from baseline in waist circumference after each dietary period
timeFrame: Week 0 and after 4 weeks (Start and End of the intervention arm)
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Antidiabetic Food Centre, Chemical Centre. Lund University
state: Skane
Study officials:
affiliation: Antidiabetic Food Centre, Lund University
name: Inger Björck, PhD Prof.
role: STUDY_CHAIR
affiliation: Antidiabetic Food Centre, Lund University
name: Juscelino Tovar, PhD
role: STUDY_DIRECTOR
affiliation: Lund University
name: Anne Nilsson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antidiabetic Food Centre, Lund University
name: Maria Johansson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilsson A, Ostman E, Preston T, Bjorck I. Effects of GI vs content of cereal fibre of the evening meal on glucose tolerance at a subsequent standardized breakfast. Eur J Clin Nutr. 2008 Jun;62(6):712-20. doi: 10.1038/sj.ejcn.1602784. Epub 2007 May 23.
citation: Nilsson AC, Ostman EM, Holst JJ, Bjorck IM. Including indigestible carbohydrates in the evening meal of healthy subjects improves glucose tolerance, lowers inflammatory markers, and increases satiety after a subsequent standardized breakfast. J Nutr. 2008 Apr;138(4):732-9. doi: 10.1093/jn/138.4.732.
citation: Nilsson AC, Ostman EM, Granfeldt Y, Bjorck IM. Effect of cereal test breakfasts differing in glycemic index and content of indigestible carbohydrates on daylong glucose tolerance in healthy subjects. Am J Clin Nutr. 2008 Mar;87(3):645-54. doi: 10.1093/ajcn/87.3.645.
citation: Liljeberg HG, Akerberg AK, Bjorck IM. Effect of the glycemic index and content of indigestible carbohydrates of cereal-based breakfast meals on glucose tolerance at lunch in healthy subjects. Am J Clin Nutr. 1999 Apr;69(4):647-55. doi: 10.1093/ajcn/69.4.647.
citation: Tovar J, Nilsson A, Johansson M, Bjorck I. Combining functional features of whole-grain barley and legumes for dietary reduction of cardiometabolic risk: a randomised cross-over intervention in mature women. Br J Nutr. 2014 Feb;111(4):706-14. doi: 10.1017/S000711451300305X. Epub 2013 Sep 24.