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Completed

NCT Number: NCT02519127

Metflex: The Effectiveness of a Dietary Intervention

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.

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Key information

Conditions

Metabolic Flexibility

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, 6200 MD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Low glycaemic load diet

Other

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

Other

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.

Primary outcomes

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

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

Secondary outcomes

  1. Metabolic flexibility, as measured by delta RQ (change in RQ) upon a mixed meal challenge

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

  2. Phenotypic flexibility markers, as measured by various blood parameters such as lipids, glucose, inflammatory markers and more, upon a mixed meal challenge

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

  3. Diet-induced changes in the Kinetic responses vs. the baseline values of RQ and various phenotypic flexibility parameters such as lipids, glucose, inflammatory markers and more

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

  4. Phenotypic flexibility markers, as measured by various blood parameters such as lipids, glucose, inflammatory markers and more, in the fasted state

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

  5. Insulin sensitivity, as measured by a hyperinsulinemic euglycemic clamp

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

Other outcomes

  1. Functional markers of cognitive performance, as measured by attention, memory and executive function

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

  2. Functional markers of physical performance, as measured by the timed up-and-go test (TUGT), the 6-minute walk test, handgrip and muscle strength tests

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

  3. Sleep quality, as assessed with the10-item Pittsburgh Sleep Quality Index

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

  4. Mood, as assessed by the Affect grid

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

  5. Quality of life, as assessed by a 32-item questionnaire, including social, spiritual, emotional, cognitive, physical, activities of daily living and integrated quality of life

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

  6. Body composition, as measured by the deuterium water method

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

  7. 36-hour blood pressure, as measured by the continuous blood pressure device mobil-o-graph

    Time frame: 36 hours within 5 days before the 6 week dietary intervention and again 36 hours in the 6th week of the dietary intervention

  8. 36-hour glycaemic response, as measured by the continuous blood glucose device ipro2 (Medtronic)

    Time frame: 36 hours within 5 days before the 6 week dietary intervention and again 36 hours in the 6th week of the dietary intervention

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Unilever R&D

Registry information

Official study title

Employing Dynamic Kinetic Responses to Demonstrate the Effectiveness of Dietary Intervention: A Challenge-based Study Using a Low-glycaemic Load Diet

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 10, 2015
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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