Metabolic FlexibilityNCT02519127

Metflex: The Effectiveness of a Dietary Intervention

A study testing Low glycaemic load diet and Western diet in people with Metabolic Flexibility, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Metabolic Flexibility
What is being tested?: Low glycaemic load diet and Western diet
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteNetherlands
Study dates: Jul 2015to 12 May 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Maastricht University Medical Center
Maastricht, 6200 MD

Other trials in Netherlands

About this study

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

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.

Conditions: Metabolic Flexibility
Being tested: Low glycaemic load diet, Western diet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low glycaemic load dietOther
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 dietOther
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.

Study groups in NCT02519127
Study group	Role	What they receive
Low glycaemic load diet	Experimental	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. Receives: Other: Low glycaemic load diet
Western diet	Experimental	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. Receives: Other: Western diet

What is being measured

The primary outcome is the main question the study is designed to answer.

Metabolic flexibility, as measured by delta RQ (change in RQ) upon a hyperinsulinemic euglycemic clamp
Measured: Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention

Secondary outcomes (5)

Metabolic flexibility, as measured by delta RQ (change in RQ) upon a mixed meal challenge
Measured: Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
Phenotypic flexibility markers, as measured by various blood parameters such as lipids, glucose, inflammatory markers and more, upon a mixed meal challenge
Measured: Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
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
Measured: Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
Phenotypic flexibility markers, as measured by various blood parameters such as lipids, glucose, inflammatory markers and more, in the fasted state
Measured: Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention
Insulin sensitivity, as measured by a hyperinsulinemic euglycemic clamp
Measured: Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201512 May 2017

First posted10 Aug 2015 (estimated)
Study startJul 2015
Primary completion12 May 2017
Study completion12 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Metabolic FlexibilityStudies of the same condition, open and under way.
More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02519127
Sponsor's protocol ID: NL52245.068.15/METC153004
Status last verified: Nov 2017
First submitted: 7 Jul 2015
Last updated: 9 Nov 2017
Results posted: No
Data monitoring committee: Yes

Publications

Fechner E, Bilet L, Peters HPF, Schrauwen P, Mensink RP. A Whole-Diet Approach Affects Not Only Fasting but Also Postprandial Cardiometabolic Risk Markers in Overweight and Obese Adults: A Randomized Controlled Trial. J Nutr. 2020 Nov 19;150(11):2942-2949. doi: 10.1093/jn/nxaa252.
PubMed 33096554
Fechner E, Bilet L, Peters HPF, Hiemstra H, Jacobs DM, Op 't Eyndt C, Kornips E, Mensink RP, Schrauwen P. Effects of a whole diet approach on metabolic flexibility, insulin sensitivity and postprandial glucose responses in overweight and obese adults - A randomized controlled trial. Clin Nutr. 2020 Sep;39(9):2734-2742. doi: 10.1016/j.clnu.2019.12.010. Epub 2019 Dec 17.
PubMed 31899037

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Flexibility trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Employing Dynamic Kinetic Responses to Demonstrate the Effectiveness of Dietary Intervention: A Challenge-based Study Using a Low-glycaemic Load Diet
ClinicalTrials.gov ID: NCT02519127
Acronym / sponsor ID: NL52245.068.15/METC153004
Conditions: Metabolic Flexibility
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Maastricht University Medical CenterUniversity, hospital or other
Collaborators: Unilever R&D
Study start: Jul 2015
Primary completion: 12 May 2017 (actual)
Study completion: 12 May 2017 (actual)
First posted: 10 Aug 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Low glycaemic load diet	Experimental	Other: Low glycaemic load dietSubjects 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.
Western diet	Experimental	Other: Western dietSubjects 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.

Who may qualify

Ages: 50 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Low glycaemic load dietSubjects 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.	Other	Low glycaemic load diet
Western dietSubjects 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.	Other	Western diet

Primary outcome

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

5 secondary outcomes

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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
Derived from this study: PubMed 33096554Fechner E, Bilet L, Peters HPF, Schrauwen P, Mensink RP. A Whole-Diet Approach Affects Not Only Fasting but Also Postprandial Cardiometabolic Risk Markers in Overweight and Obese Adults: A Randomized Controlled Trial. J Nutr. 2020 Nov 19;150(11):2942-2949. doi: 10.1093/jn/nxaa252.
Derived from this study: PubMed 31899037Fechner E, Bilet L, Peters HPF, Hiemstra H, Jacobs DM, Op 't Eyndt C, Kornips E, Mensink RP, Schrauwen P. Effects of a whole diet approach on metabolic flexibility, insulin sensitivity and postprandial glucose responses in overweight and obese adults - A randomized controlled trial. Clin Nutr. 2020 Sep;39(9):2734-2742. doi: 10.1016/j.clnu.2019.12.010. Epub 2019 Dec 17.

Related trials for Metabolic Flexibility

Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Active, not recruiting
Metformin Withdrawal In Metabolic Syndrome
Metabolic Syndrome (MetS), Glucose Intolerance
Not yet recruiting
Exercise and Prolonged Fasting to Improve Brown Adipose Tissue Function in Postmenopausal Women
Cardiometabolic Diseases, Postmenopause
Not yet recruiting
Effects of Acute Exercise in Fasting and Fed States in Individuals With Different Aerobic Fitness Levels
Physical Fitness, Mitochondrial Function, Bioenergetics
Recruiting
Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes
Type 1 Diabetes, Eating Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patrick Schrauwen, Professor principal investigator

Maastricht University Medical Center

Ronald Mensink, Professor principal investigator

Maastricht University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Low glycaemic load diet and Western diet in people with Metabolic Flexibility, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02519127, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.