Effects of Functional Ingredients in an Acute Metabolic Challenge Context

Lund University

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Other: Active Ingredient 3; Other: Active Ingredient 2; Other: Reference breakfast; Other: Active Ingredient 1; Other: Active Ingredient 4

Study type: Interventional

Funder types: Other

Identifiers

NCT02623608

AFC-JT-Ac.Ch

Details and patient eligibility

About

After an energy-rich meal the blood levels of glucose and lipids undergo a marked temporary increase, triggering a wave of oxidative stress due to the appearance of excess free radicals in adipose and muscle tissues. Elevated postprandial hypertriglyceridemia has been associated with increased risk of cardiovascular disease and type 2 diabetes. Hence, postprandial changes in different circulating biomarkers are potential predictors of cardiometabolic risk. In addition to the possibility of evaluating acute variations in metabolic risk markers in response to different types of fat, the metabolic challenge approach may serve as a challenge-meal background in order to reveal possible beneficial effects of specific food ingredients. In this study, circulating cardiometabolic disease-related biomarkers, including endotoxemia, will be assessed postprandially in search for beneficial actions of particular functional food ingredients consumed in combination with a high-fat meal.

Full description

The study will be carried out in a group of healthy mature subjects with overweight and normal fasting blood glucose values.

A randomized crossover design will be followed, in which the postprandial metabolic responses to a high fat breakfast (HF) will be compared with those registered after an identical breakfast containing a functional ("active") ingredient. Each meal will be tested in an independent experimental session. Experimental sessions will take place with1 week interval. The study will be carried out at the Food for Health Laboratory, Food for Health Science Centre - Lund University (Medicon Village, Lund).

The volunteers will consume the challenge HF alone and with 4 active ingredients, i.e. each volunteer will undergo five experimental sessions. Additionally, the plan contemplates an initial information visit that includes the screening of fasting blood glucose. In total, each volunteer completing the study will pay six visits to the Food for Health Laboratory.

Based on the results from the above-described phase, a second step of the study will focus on the impact of the order of consumption -i.e. "active ingredient" before HF and vice versa on cardiometabolic risk outcomes, as a way to optimize putative protective actions.

Enrollment: 15 patients

Sex: All

Ages: 50 to 73 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• overweight (BMI between 25 and 30)
• fasting blood glucose value ≤ 6.1 mmol/l.

Exclusion criteria

• treatment for dyslipidemia
• treatment for hypertension

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 5 patient groups

High fat meal

Experimental group

Description:

Subjects eat a high fat breakfast (reference breakfast) at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.

Treatment:

Other: Reference breakfast

High fat meal + Active Ingredient 1

Experimental group

Description:

Subjects eat the same high fat breakfast with the "active ingredient 1" at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.

Treatment:

Other: Active Ingredient 1

High fat meal + Active Ingredient 2

Experimental group

Description:

Subjects eat the same high fat breakfast with the "active ingredient 2" at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.

Treatment:

Other: Active Ingredient 2

High fat meal + Active Ingredient 3

Experimental group

Description:

Subjects eat the same high fat breakfast with the "active ingredient 3" at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.

Treatment:

Other: Active Ingredient 3

High fat meal + Active Ingredient 4

Experimental group

Description:

Subjects eat the same high fat breakfast with the "active ingredient 4" at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.

Treatment:

Other: Active Ingredient 4