CompletedNot Applicable

Metflex: The Effectiveness of a Dietary Intervention

Netherlands45 participantsStarted 2015-07

Plain-language summary

This study is testing the effectiveness of a dietary intervention by means of measuring the change in RQ upon a hyperinsulinemic euglycemic clamp challenge and by means of measuring the kinetic responses of multiple PF markers (including RQ) to an acute mixed meal challenge before and after a 6-week dietary intervention. The challenges will be applied to investigate whether the kinetic response is a better measure for health and wellbeing when compared to fasting (baseline) levels. In addition, several measures that reflect perceivable benefits like mood, quality of life, sleep quality, cognitive and physical performance will be assessed in a first exploratory attempt to link (changes in) PF to consumer perceivable benefits. 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.

Who can participate

Age range50 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed informed consent * 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: * 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…

What they're measuring

Metabolic flexibility, as measured by delta RQ (change in RQ) upon a hyperinsulinemic euglycemic clamp

Timeframe: Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention

Trial details

NCT IDNCT02519127

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05-12