Polyphenols and Overfeeding

Overfeeding Clinical Trial

— Poly-Nut  

Official title:

Polyphenols: Protection From Overfeeding-induced Insulin Resistance?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145780
• Other study ID #: 2013-807
• Status: Completed
• Phase: N/A
• First received: May 13, 2014
• Last updated: August 22, 2017
• Start date: February 2014
• Est. completion date: May 2017

Study information

• Verified date: August 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Obesity is a complex and multifactorial disease representing a major public health challenge. Indeed, overweight and obese people carry a major risk of developing insulin resistance and type 2 diabetes mellitus. It has been demonstrated that polyphenols could be used to counteract some of the mechanisms involved in the generation of insulin resistance. The model of overfeeding represents a very good study model of the metabolic complications of obesity, since it has been shown to induce a transient state of insulin resistance in the human.

The purpose of this research is to study the effects of a overfeeding (+50% of daily caloric needs over 31 days) with or without polyphenols supplementation (2g/days over 31 days) on insulin sensitivity measured in the setting of a hyperinsulinemic euglycemic clamp and on post prandial partitioning of exogenous lipids after a test meal.

During 31 days, the volunteers will consume chocolate bars, chips, chocolate breads and cola in addition to their usual diet and will be supplemented with 2g of grape polyphenols extract or with placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male

• Aged from 18 to 55 years

• Body Mass Index of 23 to 27 kg/m²

• Normal blood pressure

• Fasting glycemia < 7 mmol/L

• CRPus < 10mg/L

• Triglycerides = 3mmol/L

Exclusion Criteria:

• Medical or surgical history which may affect the results (renal -cardiovascular - hepatic- endocrine-inflammatory diseases)

• Subjects under treatment which may interfere with the measured parameters

• Eating disorder

• Intensive sportive activity

• Dairy products allergy or intolerance

Related Conditions & MeSH terms

• Insulin Resistance
• Overfeeding

Intervention

Dietary Supplement:
• 2g of grape polyphenol extract
Men will have to consume daily 2g of grape polyphenol extract during the 31 days of overfeeding.
• Dietary Supplement: 2g of placebo (lactose)
Men will have to consume daily 2g of placebo during the 31 days of overfeeding.

Locations

Country	Name	City	State
France	Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)	Pierre-bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral insulin sensitivity	Volunteers will have peripheral and hepatic insulin sensitivity determined by using a two-stage hyperinsulinemic euglycemic clamp with stable isotopically labeled tracer infusion.	During 31 days
Secondary	Hepatic insulin sensitivity	Endogenous glucose production (EGP) will be determined during the last 30 minutes of the low-dose insulin infusion.	before and after the 31 days of overfeeding
Secondary	Change in genes expression in adipose and muscle tissues	RT-PCR	Before and after the 31 days of overfeeding
Secondary	Anthropometry, Fat quantification and Abdominal fat distribution	Weight, height, waist and hip circumferences, fat mass using dual x-ray absorptiometry (DEXA) and abdominal fat distribution using resonance magnetic imaging (RMI).	During 31 days
Secondary	Fasting and Postprandial partitioning of exogenous lipid	13C enrichment will be measured in blood samples and breath test during a test meal performed before and after the 31 days of overfeeding.	Fasting and during all the postprandial period (0-300 minutes)
Secondary	Modification in intestinal microbiota	Feces analyses	Before and after the 31 days of overfeeding
Secondary	Energy expenditure and substrate oxidation with indirect calorimetry	Energy metabolism will be measured before and after the 31 days of overfeeding.	Fasting and during all the postprandial period (0-300 minutes)