The effects of timed-restricted eating on insulin sensitivity, de novo lipogenesis and liver fat in subjects with obesity and insulin resistance

Recruiting

Conditions: obesity
overweight
10018424
10013317

Registration Number: NL-OMON51439

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Ability to provide informed consent;
- Age >50 years;
- BMI >30kg/m2;
- Insulin resistance, as reflected by fasting plasma insulin >62pmol/L and/or
fasting plasma glucose > 5.5 and < 7.0 mmol/L;
- Stable weight for 3 months prior to study inclusion;
- For women; 1 year after last menstrual cycle;

Exclusion Criteria

- Use of any medication except for those related to treatment of the metabolic
syndrome or adequately dosed levothyroxine in patients with hypothyroidism;;
- Any medical condition interfering with the study outcomes or design;
- History of any psychiatric disorder, including eating disorders (anorexia,
binge eating, bulimia);
- Performing shift work;
- Performing intensive sports (>3/week);
- Smoking;
- Drugs of abuse;
- Alcohol abuse (>3 units/day);
- Contraindication for MRI (e.g. pacemaker, claustrophobia);
- Known lactose/gluten intolerance;
- Known soy, egg, milk, or peanut allergy;
- Childhood onset of obesity (<4 years);

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>insulin sensitivity, measured by indices of systemic insulin sensitivity and<br /><br>indices derived from mixed-meal tolerance measurements</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- liver fat content (degree of hepatic steatosis);<br /><br>- de novo lipogenesis, basal and in response to a meal;<br /><br>- beta cell function;<br /><br>- glucoregulatory and liporegulatory hormones (including incretins),<br /><br>immunologic markers;<br /><br>- movement activity;<br /><br>- brain activity assessed as the induced change in BOLD and ASL signals and<br /><br>resting state brain connectivity measured with fMRI;<br /><br>- neuropsychological functioning and feeding behaviour characteristics assessed<br /><br>by questionnaires and tasks;<br /><br>- assessments of motivation and impulse control of feeding behaviour<br /><br>(questionnaires);<br /><br>- assessment of craving and hunger (questionnaires);</p><br>