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Employing dynamic kinetic responses to demonstrate the effectiveness of dietary intervention: A challenge-based study using a low-glycaemic load diet

Employing dynamic kinetic responses to demonstrate the effectiveness of dietary intervention: A challenge-based study using a low-glycaemic load diet - Metflex

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43816
Enrollment
76
Registered
2016-12-22
Start date
2015-08-04
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolism Metabolism The metabolic process of the body

Interventions

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 randomly allocated to a low glycemic load diet or
Metabolic flexibility
Nutrition
Phenotypic flexibility

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Signed informed consent - Men and postmenopausal women: >= 50 and = 25.0 and 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

Exclusion criteria: - Reported participation in another nutritional or biomedical trial three months before the pre- study examination or during the study - 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

Design outcomes

Primary

MeasureTime frame
- Delta RQ (change in the mean RQ value) before (fasted state) and at the end of the 2.5-hour clamp period.

Secondary

MeasureTime frame
Secondary study parameters: - Delta RQ (change in the mean RQ value) upon a mixed meal challenge - Phenotypic flexibility markers, clustered into markers for energy/carbohydrate metabolism, protein metabolism, lipid metabolism, inflammation and vascular function, upon a mixed meal challenge - Comparison of diet-induced changes in the kinetic response to diet-induced changes in the baseline value - Phenotypic flexibility markers, clustered into markers for energy/carbohydrate metabolism, protein metabolism, lipid metabolism, inflammation and vascular function, in the fasted state - Insulin sensitivity Other study parameters: - Functional markers of cognitive and physical performance - Sleep quality, mood and quality of life - Body composition, 36-hour blood pressure, and 36-hour glycaemic response

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)