Relationship between a low fructose consumption and insulin resistance

Not Applicable

Completed

• Conditions: Insulin resistance; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN41579277
• Lead Sponsor: Fundación Canaria de Investigación Sanitaria

Brief Summary

2017 protocol in https://www.ncbi.nlm.nih.gov/pubmed/28784181 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32325919 (added 06/05/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-15
• Study Completion: 2018-04-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 438

Inclusion Criteria

1. Age between 29-66 years
2. BMI between 29 and 40.99 kg/m2

Exclusion Criteria

1. Pregnancy (female participants only)
2. Behavioral eating disorders
3. Relevant gastrointestinal disease (ulcerating colitis, Crohn’s disease, celiac disease, digestive tract cancer)
4. Excessive alcohol consumption (>28 U or 280 g/week in men, > 17 U or 168 g/week in women
5. Severe cardiovascular disease
6. Diabetes,
7. Polycystic ovary disease
8. Treatment with any medication that could alter insulin sensitivity or body weight (corticosteroids, antipsychotics, antidepressants)
9. Pharmacological treatment for clinical or subclinical hypothyroidism
10. Hyperthyroidism
11. Depression
12. Psychosis
13. Microalbumin/creatinine ratio >100 mg/g or stage IIIB or higher chronic kidney disease (glomerular filtration rate < 45 mL/min)
14. Use of medication requiring frequent dose adjustments
15. Low intellectual or mental functioning that could interfere with the participant’s compliance with the recommendations
16. If the result of the glucose overload test is blood glucose = 200 mg/dL the participant is excluded if the physician opts to add medication or insulin to the dietary and physical exercise regime.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin resistance is estimated from fasting serum glucose (measured with enzymatic methods) and insulin concentrations (measured with a chemiluminescence immunoassay method) with a computer-based Homeostasis Model Assessment system (HOMA2-IR) at baseline, 24 and 48 weeks.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Body mass index is determined using weight and height measurements at baseline, 4, 8, 12, 20, 24 and 48 weeks<br> 2. Waist circumference is determined using a nonstretchable measuring tape at baseline, 4, 8, 12, 20, 24 and 48 weeks<br> 3. Total Cholesterol, HDL cholesterol and triglycerides are measured using enzymatic methods at baseline, 24 and 48 weeks. LDL cholesterol is calculated using the Friedewald formula<br>