GlucoTRIG: measuring the impact of high carbohydrate and high fat composite meals on postprandial insulin and triglyceride responses in healthy adults – a randomised, controlled, crossover trial

Not Applicable

• Conditions: Insulin resistance; Hyperlipidemia; Diet and Nutrition - Other diet and nutrition disorders; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12622001219774
• Lead Sponsor: Riddet Institute, Massey University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-09
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

•Healthy male or female
•Ages 18-40 years old
•BMI 18.5-24.9 kg/m2 (NZ healthy BMI range, could include to 29.9 kg/m2 overweight participants)

Exclusion Criteria

•Take any glucose- or lipid-lowering drugs or supplements (e.g. statins, fibrates),
•Take any anti-hypertensive drugs (e.g. thiazide diuretics, angiotensin converting enzyme (ACE) inhibitors (or angiotensin receptor blocker (ARB), ß-blockers, calcium channel blockers), or any other medications known to affect triglyceride concentrations (e.g. antipsychotic, ß-adrenergic blockers, protease inhibitors, interferon, raloxifene, retinoic acid drugs, sirolimus, steroids or thiazides),
•Chronic use of any dietary supplementation (antioxidants, vitamins/minerals, fish oil)
•Are dieting or have any dietary restrictions or eating disorders including alcohol or drug abuse,
•Have allergy or intolerance to food products or ingredients used in the study,
•Any inflammatory condition or recent history of chronic health condition,
•Have history of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic CVD,
•Have history of diabetes, hypertension, triglycerides higher than 3 mmol/L; total cholesterol higher than 5 mmol/L;
•Have history of gastrointestinal disorder or liver disease,
•Smoke,
•Pregnant or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postprandial triglycerides (obtained from venous blood sample)[Time point: 0 min (baseline) prior to starting meal, and 180 min after starting meal];Postprandial insulin levels (obtained from venous blood sample)[Time point: 0 min (baseline) prior to starting meal, and 180 min after starting meal]

Secondary Outcome Measures

Name	Time	Method
Postprandial blood glucose (obtained from venous blood sample)[Time point: 0 min (baseline) prior to starting meal, and 180 min after starting meal];Inflammatory markers such as c-reactive protein (CRP) and interleukin-6 (IL-6). Blood samples for CRP test will be collected in heparin vacutainer and centrifuged to obtain plasma, and analysed using latex-enhanced nephelometry. Blood samples for IL-6 measurement will be collected in EDTA vacutainer and centrifuged to obtain plasma, and analysed using the IL-6 ELISA kit. [Time point: 0 min (baseline) prior to starting meal, and 180 min after starting meal]