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Polyphenols and Overfeeding

Polyphenols: Protection From Overfeeding-induced Insulin Resistance?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02145780
Acronym
Poly-Nut
Enrollment
42
Registered
2014-05-23
Start date
2014-02-28
Completion date
2017-05-31
Last updated
2017-08-23

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

Conditions

Overfeeding

Keywords

Overfeeding, Fat distribution, Subcutaneous and visceral adipose tissue, Insulin sensitivity, Insulin resistance, Peripheral and hepatic insulin sensitivity, Stable isotopes, Lipid oxidation, Energy expenditure, Muscle and subcutaneous adipose tissue gene expression

Brief 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.

Interventions

DIETARY_SUPPLEMENT2g of grape polyphenol extract

Men will have to consume daily 2g of grape polyphenol extract during the 31 days of overfeeding.

DIETARY_SUPPLEMENTDietary Supplement: 2g of placebo (lactose)

Men will have to consume daily 2g of placebo during the 31 days of overfeeding.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Peripheral insulin sensitivityDuring 31 daysVolunteers will have peripheral and hepatic insulin sensitivity determined by using a two-stage hyperinsulinemic euglycemic clamp with stable isotopically labeled tracer infusion.

Secondary

MeasureTime frameDescription
Change in genes expression in adipose and muscle tissuesBefore and after the 31 days of overfeedingRT-PCR
Anthropometry, Fat quantification and Abdominal fat distributionDuring 31 daysWeight, height, waist and hip circumferences, fat mass using dual x-ray absorptiometry (DEXA) and abdominal fat distribution using resonance magnetic imaging (RMI).
Hepatic insulin sensitivitybefore and after the 31 days of overfeedingEndogenous glucose production (EGP) will be determined during the last 30 minutes of the low-dose insulin infusion.
Modification in intestinal microbiotaBefore and after the 31 days of overfeedingFeces analyses
Energy expenditure and substrate oxidation with indirect calorimetryFasting and during all the postprandial period (0-300 minutes)Energy metabolism will be measured before and after the 31 days of overfeeding.
Fasting and Postprandial partitioning of exogenous lipidFasting and during all the postprandial period (0-300 minutes)13C enrichment will be measured in blood samples and breath test during a test meal performed before and after the 31 days of overfeeding.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026