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Continuous glucose monitoring during diets that differ in glycemic load

Continuous glucose monitoring during diets that differ in glycemic load - GLOW Glucose LOWering

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43100
Enrollment
23
Registered
2016-12-21
Start date
2017-02-16
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolisme Glucose metabolism risk factor for type 2 diabetes mellitus

Interventions

Subjects will receive a low and a high glycemic load diet in random order. Contrast in the intakes of available carbohydrates and glycemic index of those diets will be maximised within the limits of
Continuous Glucose Monitoring

Sponsors

Unilever
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Apparently healthy men and post-menopausal women (post-menopausal for at least one year) - BMI >= 25.0 and

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

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

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)