Metflex: The Effectiveness of a Dietary Intervention

Metabolic Flexibility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519127
• Other study ID #: NL52245.068.15/METC153004
• Status: Completed
• Phase: N/A
• First received: July 7, 2015
• Last updated: November 8, 2017
• Start date: July 2015
• Est. completion date: May 12, 2017

Study information

• Verified date: November 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 12, 2017
• Est. primary completion date: May 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Flexibility

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Unilever R&D

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional markers of cognitive performance, as measured by attention, memory and executive function		Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
Other	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		Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
Other	Sleep quality, as assessed with the10-item Pittsburgh Sleep Quality Index		Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
Other	Mood, as assessed by the Affect grid		Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
Other	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		Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
Other	Body composition, as measured by the deuterium water method		Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
Other	36-hour blood pressure, as measured by the continuous blood pressure device mobil-o-graph		36 hours within 5 days before the 6 week dietary intervention and again 36 hours in the 6th week of the dietary intervention
Other	36-hour glycaemic response, as measured by the continuous blood glucose device ipro2 (Medtronic)		36 hours within 5 days before the 6 week dietary intervention and again 36 hours in the 6th week of the dietary intervention
Primary	Metabolic flexibility, as measured by delta RQ (change in RQ) upon a hyperinsulinemic euglycemic clamp		Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
Secondary	Metabolic flexibility, as measured by delta RQ (change in RQ) upon a mixed meal challenge		Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
Secondary	Phenotypic flexibility markers, as measured by various blood parameters such as lipids, glucose, inflammatory markers and more, upon a mixed meal challenge		Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
Secondary	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		Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
Secondary	Phenotypic flexibility markers, as measured by various blood parameters such as lipids, glucose, inflammatory markers and more, in the fasted state		Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
Secondary	Insulin sensitivity, as measured by a hyperinsulinemic euglycemic clamp		Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention