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Effects of timing of food intake on glucose metabolism and the brain during a hypocaloric diet in obese subjects

Effects of timing of food intake on glucose metabolism and the brain during a hypocaloric diet in obese subjects - TIME-study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40991
Enrollment
25
Registered
2014-09-26
Start date
2014-11-12
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

type 2 diabetes

Interventions

Subjects will reduce their daily caloric intake with 50% for 4 weeks. Subjects will be randomized into either a hypocaloric diet group where 15% of total kcal have to be consumed with breakfast, 35%

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male - BMI * 30kg/m2 - Age 50-80 years - At least 3 out of 5 metabolic syndrome criteria: fasting plasma glucose * 5.6 mmol/l, triglycerides * 1.7 mmol/l, waist-circumference > 102 cm, HDL-cholesterol 1.04 mmol/l, blood pressure * 130/85 mmHg - Stable weight three months prior to study inclusion

Exclusion criteria

Exclusion criteria: - Use of any medication except for those related to treatment of components of the metabolic syndrome (excluding insulin, oral glucose lowering drugs, beta-blockers) - Any actual medical condition except for treated hypothyroidism and the metabolic syndrome - History of any psychiatric disorder - Shift work - Irregular sleep pattern - Intensive sports (>3/week) - Restrained eaters - History of eating disorders (anorexia, binge eating, bulimia) - Smoking, XTC, amphetamine or cocaine abuse - Alcohol abuse (>3/day) - Contraindication MRI - Lactose intolerance

Design outcomes

Primary

MeasureTime frame
* Insulin sensitivity: 2-step hyperinsulinemic euglycemic clamp with stable glucose isotope tracer * Serotonin transporter availability : [123I]FP-CIT SPECT scan * Serotonergic activity: pharmacological MRI using citalopram

Secondary

MeasureTime frame
* Motivation and impulse control: functional MRI * Abdominal and liver fat: magnetic resonance sprectroscopy (MRS) * Circulating hormones and substrates: blood drawing * Sleep duration: Actiwatch * Sympathetic and parasympathetic activity: heart rate variability * Feeding behaviour: questionnaires

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)