Metflex: The Effectiveness of a Dietary Intervention

NCT02519127 | Completed DMC

• 1 other identifier: NL52245.068.15/METC153004
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Flexibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (8)

• 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

• 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

• 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

Study Arms (2)

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.

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.

Other: Western diet

Interventions

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.

Low glycaemic load diet

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.

Western diet

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Unilever R&D: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6200 MD, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 33096554 DERIVED

• 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.

  PMID: 31899037 DERIVED

MeSH Terms

Interventions

Diet, Western

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Patrick Schrauwen, Professor

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• Ronald Mensink, Professor

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: August 10, 2015
• Study Start: July 1, 2015
• Primary Completion: May 12, 2017
• Study Completion: May 12, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Locations

NL (1)