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Metabolic Effect of High-protein Meals in Men (OPTI-PROT)

N

Nestlé

Status

Completed

Conditions

Healthy

Treatments

Other: Casein native
Other: Whey protein native
Other: Hydrolyzed milk protein
Other: Hydrolyzed casein
Other: Hydrolyzed whey protein
Other: Whey protein microgels
Other: Total milk protein native

Study type

Interventional

Funder types

Industry

Identifiers

NCT00712010
Ethics: 71/08
07.26.MET

Details and patient eligibility

About

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.

Full description

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.

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Enrollment

25 patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

25 participants in 7 patient groups

Whey protein native
Experimental group
Description:
Whey protein native versus the 6 other arms
Treatment:
Other: Total milk protein native
Other: Hydrolyzed casein
Other: Hydrolyzed whey protein
Other: Casein native
Other: Hydrolyzed milk protein
Other: Whey protein microgels
Whey protein microgels
Experimental group
Description:
Whey protein microgels versus the 6 other arms
Treatment:
Other: Total milk protein native
Other: Hydrolyzed casein
Other: Hydrolyzed whey protein
Other: Casein native
Other: Whey protein native
Other: Hydrolyzed milk protein
Hydrolyzed whey protein
Experimental group
Description:
Hydrolyzed whey protein versus the 6 other arms
Treatment:
Other: Total milk protein native
Other: Hydrolyzed casein
Other: Casein native
Other: Whey protein native
Other: Hydrolyzed milk protein
Other: Whey protein microgels
Casein native
Experimental group
Description:
Casein native versus the 6 other arms
Treatment:
Other: Total milk protein native
Other: Hydrolyzed casein
Other: Hydrolyzed whey protein
Other: Whey protein native
Other: Hydrolyzed milk protein
Other: Whey protein microgels
Hydrolyzed casein
Experimental group
Description:
Hydrolyzed casein versus the 6 other arms
Treatment:
Other: Total milk protein native
Other: Hydrolyzed whey protein
Other: Casein native
Other: Whey protein native
Other: Hydrolyzed milk protein
Other: Whey protein microgels
Total milk protein native
Experimental group
Description:
Total milk protein native versus the 6 other arms
Treatment:
Other: Hydrolyzed casein
Other: Hydrolyzed whey protein
Other: Casein native
Other: Whey protein native
Other: Hydrolyzed milk protein
Other: Whey protein microgels
Hydrolyzed milk protein
Experimental group
Description:
Hydrolyzed milk protein versus the 6 other arms
Treatment:
Other: Total milk protein native
Other: Hydrolyzed casein
Other: Hydrolyzed whey protein
Other: Casein native
Other: Whey protein native
Other: Whey protein microgels

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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