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Completed

NCT Number: NCT02747446

Metabolic Effects of Honey or Fructose:Glucose Mixtures

The metabolic effects of 7-day weight-maintenance diets containing 10% total energy as acacia honey or a fructose:glucose mixture will be assessed in a group of healthy male volunteers. Primary outcome is plasma total triglyceride concentrations after ingestion of standardized breakfast and lunch containing 25% energy as honey or fructose:glucose mixture; secondary outcome is glucose tolerance and suppression of endogenous glucose production after ingestion of 75 g glucose. Results obtained with 10% honey and 10% fructose: glucose mixture diets will be compared to results obtained with a weight-maintenance, isocaloric diet in which starch is substituted for honey or fructose:glucose mixture

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Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHUV-clinical research center

Lausanne, Canton of Vaud, CH-1011, Switzerland

About this study

Eight health males volunteers will be studied three times in a randomized order

  • Honey: volunteers will be fed a weight-maintenance diet containg 5% sugars, 20% starch, 25% acacia honey, 35% fat and 15% protein during 6 days (day 1-6); On day 7, their plasma metabolites and hormones concentrations will be monitored over 10 hours during which they will receive a breakfast and a lunch containing honey; on day 8, they will have a 75g oral glucose4 + 375 mg 13C-labelled glucose tolerance test, and their plasma glucose and insulin concentrations will be monitored over 4 hours; glucose kinetics will be measured by 6,6 deuterated glucose
  • FG: volunteers will be fed a weight-maintenance diet containg 5% sugars, 20% starch, and 25% of a fructose:glucose mixture matching the composition of acacia honey, 35% fat and 15% protein during 6 days (day 1-6); On day 7, their plasma metabolites and hormones concentrations will be monitored over 10 hours during which they will receive a breakfast and a lunch containing fructose and glucose; on day 8, they will have a 75g oral glucose + 375 mg 13C-labelled glucose tolerance test, and their plasma glucose and insulin concentrations will be monitored over 4 hours; glucose kinetics will be measured by 6,6 deuterated glucose
  • Control: volunteers will be fed a weight-maintenance diet containg 5% sugars, 45% starch, 35% fat and 15% protein during 6 days (day 1-6); On day 7, their plasma metabolites and hormones concentrations will be monitored over 10 hours during which they will receive a breakfast and a lunch with no added sugar; on day 8, they will have a 75g oral glucose + 375 mg 13C-labelled glucose tolerance test, and their plasma glucose and insulin concentrations will be monitored over 4 hours; glucose kinetics will be measured by 6,6 deuterated glucose

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • health volunteer

Exclusion criteria

  • BMI < 19.5
  • BMI > 25
  • Smoker
  • Any disease
  • current treatment with any drug

Treatment and study plan

added sugar

Dietary Supplement

isocaloric substitution of added sugars (honey or FG) for starch

Primary outcomes

  1. plasma total triglyceride profile

    Time frame: 7-day dietary intervention

    plasma triglyceride concentrations measured before and after ingestion of a breakfast and a lunch

Secondary outcomes

  1. glucose tolerance

    Time frame: 7-day dietary intervention

    plasma glucose and insulin concentration and suppression of endogenous glucose production after ingestion of 75 g glucose

Sponsors and collaborators

Lead sponsor

Luc Tappy, MD

Other

Collaborators

  • Agroscope Liebfeld Posieux, Liebfeld-Bern Switzerland

Registry information

Official study title

Effects of a Dietary Honey or Isomolar Fructose:Glucose Mixture on Glucose Tolerance and Blood Lipid Profile in Healthy Male Volunteers

Acronym: HONEY

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 21, 2016
Registry last updated
Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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