Continuous glucose monitoring during diets that differ in glycemic load

Completed

• Conditions: Metabolisme; Glucose metabolism; risk factor for type 2 diabetes mellitus

• Registration Number: NL-OMON43100
• Lead Sponsor: nilever

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 23

Inclusion Criteria

- Apparently healthy men and post-menopausal women (post-menopausal for at least one year)
- BMI >= 25.0 and <= 35.0 kg/m2
- Age: 50-70 yrs
- Signed informed consent

Exclusion Criteria

- Having a medical conditions which might affect the study measurements.
- Reported use of over-the-counter or prescribed medication or food supplements, which may interfere with study measurements.
- Use of oral antibiotics 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.
- Reported intense sporting activities > 2h/w.
- 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.
- Reported dietary habits: medically prescribed diet, slimming diet, vegetarian.
- Reported weight loss/gain (> 3 kg) in the last 2 months before the study.
- Blood donation in the past 3 months
- Known allergy or intolerance to food products.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in 2-hour postprandial glucose concentrations between the low GL<br /><br>and the high GL diets, as measured with the CGM device. For this, the positive<br /><br>incremental area under the curve during two hours (+iAUC0-2h) after the three<br /><br>main meals (breakfast, lunch, dinner) for each of the three days of each<br /><br>dietary period will be calculated.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Differences in glucose concentrations between the low and the high GL diets as<br /><br>quantified by the total area under the curve (tAUC) for the full 3 days and<br /><br>also for daytime [07:00-22:00] and night-time [22:01-06:59]; the difference in<br /><br>glucose variability between the low and the high GL diets; and the agreement<br /><br>between venous plasma glucose concentrations and CGM values.</p><br>