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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001219774
Enrollment
15
Registered
2022-09-09
Start date
2022-09-15
Completion date
2023-02-15
Last updated
2022-09-19

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

Conditions

None listed

Brief summary

Elevated fasting plasma insulin and triglyceride levels are known to increase risk for cardiovascular disease (CVD) and type 2 diabetes. Although the measure of fasting plasma triglyceride and insulin levels may represent a cumulative effect of the dietary habits and disease, it does not allow the understanding of the contribution of individual foods/meals to CVD risk. Therefore, the current study examines the impact of a high-carbohydrate, low-fat meal and low-carbohydrate, high fat meal on the GlucoTRIG value that measures both insulin and triglyceride postprandial responses. The study will provide further evidence for GlucoTRIG to be a physiologically relevant index for ranking the healthiness of composite meals for reducing the risk of diet-related metabolic diseases.

Interventions

The study is an acute, randomised, crossover design involving 15 healthy participants (male or female) and consisting of three treatment arms. All treatment arms will be isocaloric and only differing in macronutrient compositions. All participants will undergo all three treatment arms. The three treatment arms consist of (1) a reference meal of 480 kcal energy, 19.8g proteins (16.5%), 13.9g fats (26.1%), 66.1g carbohydrates (55.1%), and 3.1g fibre (0.6%); (2) a high-carbohydrate, low-fat test m

The study is an acute, randomised, crossover design involving 15 healthy participants (male or female) and consisting of three treatment arms. All treatment arms will be isocaloric and only differing in macronutrient compositions. All participants will undergo all three treatment arms. The three treatment arms consist of (1) a reference meal of 480 kcal energy, 19.8g proteins (16.5%), 13.9g fats (26.1%), 66.1g carbohydrates (55.1%), and 3.1g fibre (0.6%); (2) a high-carbohydrate, low-fat test meal consisting of 479 kcal energy, 20g proteins (16.7%), 6.7g fats (12.6%), 81.3g carbohydrates (67.9%), and 4.1g fibre (0.9%); and (3) a low-carbohydrate, high-fat test meal consisting of 479 kcal energy, 22.9g proteins (19.1%), 27.1g fats (50.9%), 34.2g carbohydrates (28.6%), and 3.5g fibre (1.1%). Participants will be asked to complete a consent form for participation, a brief medical questionnaire, a health screening questionnaire, eating attitudes testing questionnaire, and a physical activity questionnaire at the screening visit. Screening visit will involve taking anthropometric measurements (weight, height, body muscle and fat mass, etc.), blood pressure, and a finger prick test to obtain fasting lipid profile and glycated haemoglobin A1c (HbA1c) for eligibility. Each study visit comprises 3.5 hours where eligible participants will arrive at the clinical facility at Massey University after an overnight fast (at least 12 hours). At each study visit, participants will be asked to provide a completed 24 h food recall record to ensure compliance and that there are no significant changes to their diet throughout the study. At each study visit, a venous blood sample (18 mL) for fasting glucose, insulin and triglycerides at time point 0 min (baseline) will be collected. They will then be given a meal to consume within 20 minutes. The meal ingestion will be timed and participants will have to finish their meal within 20 minutes. The plate will be visually checked to ensure there are no leftovers remaining. Following 3-hour post meal, another venous blood sample (18 mL) will be collected at 180 min for the same measurements. Blood draws will be taken by having the participant lie in a supine position and blood samples taken via venipuncture on the antecubital fossa region of the arm into blood vacutainers. Blood collected will be immediately centrifuged and aliquot for storage at -80degC until analysis. Primary measure includes measuring postprandial triglycerides and insulin levels after consuming reference and test meals on separate occasions. Postprandial glucose and inflammatory markers including c-reactive protein (CRP), interleukin-6 (IL-6) as a secondary measure will also be taken. The data will be used to calculate the GlucoTRIG value of each meal to rank the healthiness of each meal. There will be at least a week of washout between each visit. Participants will be instructed to maintain a consistent diet without any dietary alterations throughout the duration of the study. They are to also abstain from alcohol and beverages such as teas, coffees, and energy drinks (both caffeinated and decaffeinated), all health supplements, and strenuous activity during the 24h period before each study visit.

Sponsors

Riddet Institute, Massey University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026