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Completed

NCT Number: NCT00712010

Metabolic Effect of High-protein Meals in Men

The purpose of the clinical study is to investigate the effect of the protein quality of high-protein meal replacements on the management of post-prandial blood glucose in healthy men.

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Key information

Conditions

Healthy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Nestec Clinical Development Unit / Metabolic Unit

Lausanne, 1000, Switzerland

About this study

It was a double-blind, single center, randomized, crossover adaptive study design with 7 arms.

The subjects were submitted to 7 tests of ingestion of a high-protein meal replacement (test meal) in randomized order preferably a week apart. The 7 test meals were isocaloric, isonitrogenous and differed in their protein quality.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 20 - 50 years, male
  • Healthy as determined by a medical questionnaire
  • Normal weight: BMI 20 - 24.9 kg.m-2
  • Normal fasting glycemia and insulinemia
  • Normal fasting lipidemia (cholesterol and triglycerides)
  • Normal liver function (transaminases, γ-GT) and kidney function (urea, creatinine)
  • Capable of fast ingestion of the meal replacement (5-10 min)
  • Having signed informed consent

Exclusion criteria

  • Intestinal or metabolic diseases/disorders such as diabetic, renal, dyslipidemia, hepatic, hypertension, pancreatic or ulcer, including lacto-intolerance.
  • Hypertension >150/95 mmHg
  • Have had a gastrointestinal surgery
  • Have a regular consumption of medication
  • Vegetarian, vegan, under dietary supplements
  • Have an alcohol intake: > 2 units a day or smoker
  • Currently participating or having participated in a clinical trial during the last month
  • Having given blood in the last month
  • More than 5 x 45 min of intense exercise per week
  • Volunteer who cannot be expected to comply with treatment

Treatment and study plan

Whey protein native

Other

Whey protein native against the 6 other arms

Whey protein microgels

Other

Whey protein microgels versus the six other arms

Hydrolyzed whey protein

Other

versus the six other arms

Casein native

Other

versus the six other arms

Hydrolyzed casein

Other

versus the six other arms

Total milk protein native

Other

versus the six other arms

Hydrolyzed milk protein

Other

versus the six other arms

Primary outcomes

  1. Post-prandial Plasma Responses of Glucose Concentrations

    Time frame: 180 minutes

    The concentrations of glucose were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.

  2. Calculation of the Area Under Curve Over Baseline for Plasma Insulin

    Time frame: 180 minutes from baseline

    The concentrations of insulin were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.

Secondary outcomes

  1. Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids

    Time frame: 180 minutes

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Acute Metabolic Effect of the Protein Quality of a High-protein Meal Replacement in Healthy Men

Acronym: OPTI-PROT

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Jul 9, 2008
Registry last updated
Aug 14, 2013

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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