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Metflex: The Effectiveness of a Dietary Intervention

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ClinicalTrials.gov Identifier: NCT02519127
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : November 9, 2017
Sponsor:
Collaborator:
Unilever R&D
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Metabolic Flexibility Other: Low glycaemic load diet Other: Western diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Employing Dynamic Kinetic Responses to Demonstrate the Effectiveness of Dietary Intervention: A Challenge-based Study Using a Low-glycaemic Load Diet
Study Start Date : July 2015
Actual Primary Completion Date : May 12, 2017
Actual Study Completion Date : May 12, 2017

Arm Intervention/treatment
Experimental: 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.
Other: 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.

Experimental: 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.
Other: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519127


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Unilever R&D
Investigators
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Principal Investigator: Patrick Schrauwen, Professor Maastricht University Medical Center
Principal Investigator: Ronald Mensink, Professor Maastricht University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02519127    
Other Study ID Numbers: NL52245.068.15/METC153004
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017