Continuous Glucose Monitoring During Diets That Differ in Glycemic Load

NCT02926118 | Completed

• 1 other identifier: REF-CSC-2682
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This study test whether a Continuous Glucose Monitor can pickup differences in glucose (in the interstitial fluid) during a dietary intervention using meals with either a high with a low glycemic load.

Conditions

Glucose Metabolism Disorders

Keywords

Glucose; Continuous glucose monitor; Glycemic load; Dietary intervention

Outcome Measures

Primary Outcomes (1)

• Post prandial glucose concentration

  Difference in glucose concentrations between the low glycemic load and the high glycemic load diet. Incremental area under the curve after the three main meals (breakfast, lunch, dinner) during both dietary interventions will be calculated. The nine post prandial periods for both low and high glycemic load diet per subject will be combined in the mixed model.

  0 - 120 minutes after the start of each of the 3 main meals (breakfast, lunch dinner)

Secondary Outcomes (5)

• Three-day glucose concentration

  From start of dietary intervention until the end 3 days later

• Day time glucose concentration

  Between 07:00-22:00 h

• Night time glucose concentration

  Between 22:01-26:59 h

• Glucose variability

  From start of dietary intervention until the end 3 days later

• Comparison of continuous interstitial glucose with venous blood glucose

  -30, -15, 15, 30, 45, 60, 90 and 120 minutes after consumption of a standard meal

Other Outcomes (3)

• Carry over of the dietary intervention into the next day

  0 - 120 minutes after the standard meal

• Carry over as measured in venous blood versus as measured during continuous glucose monitoring

  0 - 120 minutes after the standard meal

• Post prandial glucose concentration during breakfast, lunch or dinner.

  0 - 120 minutes after each of the start of the meal

Study Arms (2)

Low glycemic load

EXPERIMENTAL

Low glycemic load

Dietary Supplement: Low glycemic load

High glycemic load

EXPERIMENTAL

High glycemic load

Dietary Supplement: High glycemic load

Interventions

Low glycemic load DIETARY_SUPPLEMENT

Low glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days

Low glycemic load

High glycemic load DIETARY_SUPPLEMENT

High glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days

High glycemic load

Eligibility Criteria

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

You may qualify if:

• Apparently healthy males and post-menopausal females
• Age at start of the study ≥ 50 and ≤ 70 years
• Body mass index (BMI) ≥ 25.0 and ≤ 35.0 kg/m2
• Fasting blood glucose value of subjects is ≥ 3.4 and \< 6.1 mmol/L at screening
• Being used to eat three meals a day
• Having a general practitioner
• Agreeing to be informed about medically relevant personal test-results by a physician
• Accessible veins on arms as determined by examination at screening.

You may not qualify if:

• Having a medical conditions which might affect the study measurements (including but not limited to: diabetes type 1 and type 2, gastrointestinal disorders, gastrointestinal surgery and inflammatory diseases, as judged by the study physician
• Reported use of over-the-counter or prescribed medication or food supplements, which may interfere with study measurements as judged by the principal investigator
• Use of oral antibiotics in 40 days or less prior to the start of the study
• Reported participation in another nutritional or biomedical study 3 months before the screening or during the study
• Reported participation in night shift work 2 weeks prior to screening or during the study. Night work is defined as working between mid-night and 6.00 am
• Reported intense sporting activities \> 2h/w. Intense sporting activities are defined as those activities that cause a lack of breath which limits the ability to have a normal conversation
• Reported alcohol consumption \> 10 units/week (female) or \> 14 units/week (male)
• Reported use of any nicotine containing products in the 6 months preceding the study and willing to abstain from use of nicotine containing products during the study itself
• Reported dietary habits: medically prescribed diet, slimming diet, vegetarian
• Reported weight loss/gain (\> 3 kg) in the last 2 months before the study
• Being an employee of Unilever or research departments in NUTRIM or the Maastricht University Medical Centre (MUMC+) collaborating in this study
• Known allergy or intolerance to food products.
• Blood donation in the past 3 months

Sponsors & Collaborators

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

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mensink Ronald P, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 6, 2016
• Study Start: April 27, 2017
• Primary Completion: July 13, 2017
• Study Completion: October 18, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)