NCT04444219

Brief Summary

Obesity, characterized by an increase in body weight that results in excessive fat accumulation, is a global health problem. Recently, it has also been shown that obesity is associated with low-grade chronic systemic inflammation in adipose tissue. This condition is mediated by activation of the innate immune system in adipose tissue that promotes inflammation and oxidative stress and triggers a systemic acute-phase response. Previous research points towards the potential of phytochemicals in food as part of nutritional strategies for the prevention of obesity and associated inflammation, as well as, increase in insulin sensitivity in diabetic patients. The last decade, mushrooms have attracted the research interest as functional foods rich in beta-glucan with desirable health benefits in several metabolic disorders without the side effects of pharmacological treatment. Edible mushrooms are highly nutritious and exhibit beneficial effects on several inflammatory diseases such as cancer, heart disease, diabetes,, high blood pressure. However, the postprandial effect of mushrooms in human biological samples is still undetermined. To this end, the current study aims to investigate if there is any effect at postprandial glucose, insulin responses and appetite hormones. Fifteen apparently men and women with Metabolic Syndrome, aged 18-65 years old, will be enrolled based on certain inclusion and exclusion criteria. After enrollment, the volunteers will undergo a medical and dietary assessment and their health status will be evaluated through a complete blood count. On the day of the experiment and after overnight fasting, the volunteers will consume one of two breakfast meal, including 114g bread, 40g cheese and 15g dry mushrooms (meal 1) or 114g bread, 40g cheese and 200g tomatoes (meal 2). Blood samples will be obtained on timepoints 0h, 30min, 1h, 1,5h, 2h, 2,5h and 3h after breakfast intake. Two weeks later, the same volunteers will consume the other breakfast meal. After collection, the glucose and insulin values will be identified in plasma samples. Additionally, some appetite hormones will be measureD in serum samples.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

June 20, 2020

Last Update Submit

September 20, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Difference of Glucose levels

    Difference of Glucose levels after consuming the two meals

    1 month

  • Difference of Insulin levels

    Difference of insulin levels after consuming the two meals

    1 month

  • Difference of appetite hormones levels

    Difference of appetite hormones levels after consuming the two meals

    1 month

Study Arms (2)

Breakfast meal_1

OTHER

100 g white bread, 40 g yellow cheese and Κing Oyster mushrooms (test meal)

Other: Breakfast meals

Breakfast meal_2

OTHER

100 g white bread, 40 g yellow cheese and 6-7 cherry tomatoes (control meal)

Other: Breakfast meals

Interventions

Fifteen volunteers will undergo a medical and dietary assessment and their health status will be evaluated through a complete blood count. Then, they will come after overnight fasting and will consume one of two breakfast meals, including 114g bread, 40g cheese and 15g dry mushrooms (meal 1) or 114g bread, 40g cheese and 200g tomatoes (meal 2). Blood samples will be obtained on timepoints 0h, 30min, 1h, 1,5h, 2h, 2,5h and 3h after breakfast intake. Two weeks later, the same volunteers will consume the other breakfast meal.

Breakfast meal_1Breakfast meal_2

Eligibility Criteria

Age18 Years - 54 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years \< Age \< 75 years BMI \> 25 kg/ m2 Metabolic Syndrome

You may not qualify if:

  • Hepatotoxic Medication Diabetes Mellitus Dysthyroidism, hypopituitarism, Cushing syndrome / disease Pregnancy, lactation Psychiatric or mental disorder Any use of antioxidant-phytochemical rich supplement, vitamin D supplement, nti-, pre- or pro-biotics within 3 months pre-intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andriana Kaliora

Athens, 17671, Greece

Location

Related Publications (5)

  • Marseglia L, Manti S, D'Angelo G, Nicotera A, Parisi E, Di Rosa G, Gitto E, Arrigo T. Oxidative stress in obesity: a critical component in human diseases. Int J Mol Sci. 2014 Dec 26;16(1):378-400. doi: 10.3390/ijms16010378.

    PMID: 25548896BACKGROUND
  • Cardwell G, Bornman JF, James AP, Black LJ. A Review of Mushrooms as a Potential Source of Dietary Vitamin D. Nutrients. 2018 Oct 13;10(10):1498. doi: 10.3390/nu10101498.

    PMID: 30322118BACKGROUND
  • Abdali D, Samson SE, Grover AK. How effective are antioxidant supplements in obesity and diabetes? Med Princ Pract. 2015;24(3):201-15. doi: 10.1159/000375305. Epub 2015 Mar 14.

    PMID: 25791371BACKGROUND
  • El Khoury D, Cuda C, Luhovyy BL, Anderson GH. Beta glucan: health benefits in obesity and metabolic syndrome. J Nutr Metab. 2012;2012:851362. doi: 10.1155/2012/851362. Epub 2011 Dec 11.

    PMID: 22187640BACKGROUND
  • Ganesan K, Xu B. Anti-Obesity Effects of Medicinal and Edible Mushrooms. Molecules. 2018 Nov 5;23(11):2880. doi: 10.3390/molecules23112880.

    PMID: 30400600BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Breakfast

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assosiate Professor in Foods and Human Nutrition

Study Record Dates

First Submitted

June 20, 2020

First Posted

June 23, 2020

Study Start

June 1, 2020

Primary Completion

March 31, 2021

Study Completion

July 31, 2021

Last Updated

September 27, 2021

Record last verified: 2021-09

Locations