Personalized Glucose Optimisation through Nutritional Interventio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1056

Inclusion Criteria

Overweight/obese (BMI >= 25 kg/m2 < 40 kg/m2) Caucasian men and women (age:
40-75 years) who are predominantly muscle (MIR) or liver (LIR) insulin
resistant will be included from the general population. Stable body weight for
at least 3 months (+/-3 kg).

Exclusion Criteria

- Pre-diagnosis of type 1 or type 2 diabetes mellitus
- Renal or hepatic malfunctioning (pre-diagnosis or determined based on
ALAT, ASAT and creatinine values)
- Gastrointestinal diseases or abdominal surgery (allowed i.e.: appendectomy,
cholecystectomy)
- Food allergies, intolerances and/or dietary restrictions interfering with the
study (including special diets, vegetarians and eating disorders)
- Cardiovascular diseases (e.g. heart failure) or cancer (e.g. non-
invasive skin cancer allowed)
- High blood pressure (untreated >160/100 mmHg, drug-regulated >140/90 mmHg)
- Diseases affecting glucose and/or lipid metabolism (e.g. pheochromocytoma,
Cushing*s syndrome, acromegaly)
- Anemia defined as Hb men <8.5 and women <7.5 mmol/l
- Diseases with a life expectation shorter than 5 years
- Major mental disorders
- Drug treated thyroid diseases (well substituted hypothyroidism is allowed
inclusion)
- Other physical/mental conditions that may interfere with study outcomes
- Medication known to interfere with study outcomes (e.g. PPAR-a or PPAR-γ
agonists (fibrates), sulfonylureas, biguanides, a-glucosidase inhibitors,
thiazolidinediones, repaglinide, nateglinide and insulin, chonic use of NSAIDs)
- Use of certain anticoagulants
- Use of antidepressants (stable use >= 3 months prior to and during study
allowed)
- Use of statins (stable use >= 3 months prior to and during study allowed)
- Use of β-blockers (only for the extensive phenotyping participants)
- Chronic corticosteroids treatment (>7 consecutive days of treatment)
- Use of antibiotics within 3 months prior to the study
- Participation in a regular organized sports activities (>4 hours per week)
- Having a restricted dietary pattern interfering with the study diets
(e.g. vegan or Atkins diet)
- Plans to lose weight
- Abuse of alcohol (alcohol consumption >14 units/week) and/or drugs
- Not willing to limit alcohol consumption to 7 drinks per week
- Regular (including use of e-cigarettes)
- Use of strong vitamins or other dietary supplements expected to interfere
with the study outcomes
- Pregnant or lactating women, or women who are planning to become pregnant
- Inability to comply with the study diet
- Blood donation within the last 3 months
- Participation in possibly interfering studies within the last 3 months
- Inability to understand study information and/or communicate with staff
- Unwillingness to be randomized or sign informed consent
- Unwillingness to save data for 15 years.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to establish the effect of a<br /><br>metabolically targeted, macronutrient manipulated 12-week dietary intervention<br /><br>on the change in disposition index (composite marker of first phase insulin<br /><br>secretion and insulin sensitivity) between optimal and suboptimal diet after<br /><br>participants follow an optimal or suboptimal diet for their phenotype (MIR or<br /><br>LIR).</p><br>

Secondary Outcome Measures