Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2015-07-31
2017-05-12
Brief Summary
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Subjects will be randomly allocated to a low glycemic load diet or a 'Western' diet for 6 weeks. Before and after the intervention several measurements will take place. The low glycemic load diet will be high in polyphenols, protein, vegetables, pulses, fibres and nuts, and low in glycemic carbohydrates. All these dietary factors have been shown to improve glycemic control and/or to reduce metabolic syndrome risk factors.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Low glycaemic load diet
Subjects will be following a low glycaemic load diet, typically high in polyphenols, proteins, vegetables, pulses, fibres and nuts, and low in glycemic carbohydrates, for six continuous weeks.
Low glycaemic load diet
Subjects will first be subjected to a 2-week run-in diet consisting of products that fit into a typical 'Western' diet. Thereafter subjects will be allocated to a low glycemic load diet for 6 weeks.
Western diet
Subjects will be following a western diet, typically high in saturated fat, refined sugars and salt, and low in fruit and vegetables and fibers, for six continuous weeks.
Western diet
Subjects will first be subjected to a 2-week run-in diet consisting of products that fit into a typical 'Western' diet. Thereafter subjects will be allocated to a 'Western' diet for 6 weeks.
Interventions
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Low glycaemic load diet
Subjects will first be subjected to a 2-week run-in diet consisting of products that fit into a typical 'Western' diet. Thereafter subjects will be allocated to a low glycemic load diet for 6 weeks.
Western diet
Subjects will first be subjected to a 2-week run-in diet consisting of products that fit into a typical 'Western' diet. Thereafter subjects will be allocated to a 'Western' diet for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* Men and postmenopausal women: ≥ 50 and ≤ 70 years at the start of the study
* Body mass index (BMI) ≥ 25.0 and ≤ 35.0 kg/m2
* Healthy (as determined by dependent physician): no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases) as assessed by physical characteristics and health and lifestyle questionnaire
* Fasting blood glucose value ≤ 6.9 mmol/litre at screening
* Waist circumference \>94 cm for males, \>80 cm for females
* Maximum 2.5 hours of moderate to vigorous physical activity per week (during last 3 months)
* Agreeing to be informed about medically relevant personal test-results by a physician
* Willing to comply to study protocol during study
* Accessible veins on arms as determined by examination at screening
Exclusion Criteria
* Blood donation in the past three months
* Reported participation in night shift work two weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM;
* Consumption of \> 21 alcoholic units for males, \> 14 alcohol units for females in a typical week;
* Reported use of any nicotine containing products in the six months preceding the study and during the study itself;
* Reported dietary habits: medically prescribed diet, slimming diet, vegetarian;
* People who are familiar with an allergy or intolerance to any of the provided food products
* Reported weight loss or weight gain (10%) in the last six months prior to the pre-study screening;
* Clinically relevant abnormalities in clinical chemistry at screening (to be judged by the study physician);
* Being an employee of Unilever or the collaborating research departments in Maastricht University Medical Centre (MUMC+);
* Taking medication, which may interfere with study measurements, as judged by the responsible physician;
* Subjects, who do not want to be informed about unexpected medical findings, or do not wish that their treating physician is informed.
50 Years
70 Years
ALL
Yes
Sponsors
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Unilever R&D
INDUSTRY
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Patrick Schrauwen, Professor
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Ronald Mensink, Professor
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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Maastricht University Medical Center
Maastricht, , Netherlands
Countries
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References
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Fechner E, Bilet L, Peters HPF, Schrauwen P, Mensink RP. A Whole-Diet Approach Affects Not Only Fasting but Also Postprandial Cardiometabolic Risk Markers in Overweight and Obese Adults: A Randomized Controlled Trial. J Nutr. 2020 Nov 19;150(11):2942-2949. doi: 10.1093/jn/nxaa252.
Fechner E, Bilet L, Peters HPF, Hiemstra H, Jacobs DM, Op 't Eyndt C, Kornips E, Mensink RP, Schrauwen P. Effects of a whole diet approach on metabolic flexibility, insulin sensitivity and postprandial glucose responses in overweight and obese adults - A randomized controlled trial. Clin Nutr. 2020 Sep;39(9):2734-2742. doi: 10.1016/j.clnu.2019.12.010. Epub 2019 Dec 17.
Other Identifiers
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NL52245.068.15/METC153004
Identifier Type: -
Identifier Source: org_study_id