NCT02041143

Brief Summary

This trial is an exploratory study in order to determine whether the ingestion of one type of protein (milk protein/CHO/Fat) vs.placebo (CHO/Fat) 2 hours before bed time results in the extension of the post-prandial window of anabolism during the night by increasing whole body protein balance as well as muscle protein fractional synthesis rate (FSR).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

3 months

First QC Date

January 16, 2014

Last Update Submit

October 27, 2015

Conditions

Protein Synthesis Overnight

Outcome Measures

Primary Outcomes (1)

  • muscle FSR determination

    Muscle protein FSR (fractional synthesis rate) will be determined using primed constant infusions of \[13C6\] phenylalanine for 5 hours starting around from 03:00 a.m. (see flow chart attached). Whole body protein balance will be measured throughout the night using \[15N\]glycine (200mg) which will be orally taken with the trial product in the evening.

    Within 24 hours of product intake

Secondary Outcomes (3)

  • Activation of signaling pathways involved in skeletal muscle protein balance

    Within 24 hours after product intake

  • Glucose metabolism

    Within 24 hours after product intake

  • Plasma amino acid availability

    Within 24 hours after product intake

Study Arms (2)

Milk protein

EXPERIMENTAL

Study product will provide 25 g of protein to subjects. One single supplement will be taken.

Dietary Supplement: Placebo

Placebo

PLACEBO COMPARATOR

Placebo (no protein)

Dietary Supplement: Milk protein

Interventions

Milk proteinDIETARY_SUPPLEMENT

Study product will provide 25 g of protein to subjects.

Placebo
PlaceboDIETARY_SUPPLEMENT

Product with no protein

Milk protein

Eligibility Criteria

Age55 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Healthy as determined by the medical questionnaire and the medical visit including blood sampling
  • y of age
  • BMI (19.0 - 25.0 kg/ m²)
  • Having signed the consent form

You may not qualify if:

  • Digestive (intestinal, gastric, hepatic or pancreatic), renal or metabolic disease, as determined by the medical (screening) visit and a blood chemistry analysis (glucose, total cholesterol, LDL, HDL, triglycerides, aspartate transaminase, alanine aminotransferase, gamma glutamyl transpeptidase, C Reactive Protein, creatinin)
  • Heart or other organ disease
  • Arterial hypertension (Systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg)
  • Any clotting trouble (diagnosed by Prothrombin time (PT), activated Partial Thromboplastin Time (aPTT), fibrinogen measures and platelets number (the latter is part of a classical blood cells counting at screening)
  • Any inflammatory disease in the past four weeks
  • Use of specific medications
  • Recent major surgery (3 months)
  • History of major gastro-intestinal surgery (gastric bypass, intestinal resection etc…)
  • History of cancer within the past year
  • Significant weight loss during the last 3 months (5% and more)
  • Food allergies, especially cow milk protein allergies
  • Special diets especially vegetarian, high protein or weight loss program (anamnesis)
  • Smokers
  • High level structured exercise 3 times a week (e.g.: fitness club, competitions…)
  • Have a high alcohol consumption (more than 2 drinks/day)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metabolic Unit

Lausanne, Canton of Vaud, 1000, Switzerland

Location

Related Publications (1)

  • Karagounis LG, Beaumont M, Donato-Capel L, Godin JP, Kapp AF, Draganidis D, Pinaud S, Vuichoud J, Shevlyakova M, Rade-Kukic K, Breuille D. Ingestion of a Pre-bedtime Protein Containing Beverage Prevents Overnight Induced Negative Whole Body Protein Balance in Healthy Middle-Aged Men: A Randomized Trial. Front Nutr. 2019 Nov 29;6:181. doi: 10.3389/fnut.2019.00181. eCollection 2019.

    PMID: 31850360DERIVED

MeSH Terms

Interventions

Milk Proteins

Intervention Hierarchy (Ancestors)

Animal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaMilkDairy ProductsFood and Beverages

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 20, 2014

Study Start

February 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations

CH(1)