Effects of Functional Ingredients in an Acute Metabolic Challenge Context

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Metabolic Syndrome

Clinical Trial Details

NCT number	NCT02623608
Study type	Interventional
Source	Lund University
Contact
Status	Completed
Phase	N/A
Start date	August 2015
Completion date	July 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04635202` - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome	N/A
Completed	`NCT05343858` - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome	N/A
Completed	`NCT04053686` - An Intervention to Reduce Prolonged Sitting in Police Staff	N/A
Active, not recruiting	`NCT05891834` - Study of INV-202 in Patients With Obesity and Metabolic Syndrome	Phase 2
Recruiting	`NCT05040958` - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Active, not recruiting	`NCT02500147` - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)	Phase 4
Recruiting	`NCT03227575` - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control	N/A
Recruiting	`NCT05972564` - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function	Phase 1/Phase 2
Completed	`NCT03289897` - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan	N/A
Recruiting	`NCT05956886` - Sleep Chatbot Intervention for Emerging Black/African American Adults	N/A
Completed	`NCT06057896` - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting	`NCT03613740` - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion	Phase 2
Completed	`NCT04498455` - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency	Phase 4
Completed	`NCT05688917` - Green Coffee Effect on Metabolic Syndrome	N/A
Completed	`NCT04117802` - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome	N/A
Completed	`NCT03697382` - Effect of Daily Steps on Fat Metabolism	N/A
Completed	`NCT03241121` - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome	N/A
Completed	`NCT04509206` - Virtual Teaching Kitchen	N/A
Completed	`NCT05124847` - TREating Pediatric Obesity	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.