NCT02315014

Brief Summary

To determine whether a balanced total daily dietary protein distribution supplemented with whey protein during a weight-loss intervention will result in increased muscle protein synthesis

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

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

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
Last Updated

December 11, 2014

Status Verified

November 1, 2014

Enrollment Period

3 months

First QC Date

November 13, 2014

Last Update Submit

December 10, 2014

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

  • muscle protein synthesis

    protein synthesis is evaluated in muscle biopsy tissue

    up to 4 weeks

Secondary Outcomes (1)

  • body composition is evaluated using DEXA

    up to 4 weeks

Study Arms (2)

whey protein

EXPERIMENTAL

whey protein micelles

Other: whey protein

placebo

PLACEBO COMPARATOR

calorie-free placebo

Other: placebo

Interventions

whey proteinOTHER

whey protein.

whey protein
placeboOTHER

placebo.

placebo

Eligibility Criteria

Age60 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight/obese (BMI 27-40 kg/m2)
  • Non-smokers
  • Non-diabetic
  • No history of hyperlipidemia
  • Not taking medications thought to interfere with study
  • Considered generally healthy

You may not qualify if:

  • Efforts to lose weight in previous 16 weeks
  • Hyperlipidemia
  • Blood pressure ≥ 140/90 mmHg
  • Smoking
  • Heart and other organ disease
  • Type 2 diabetes
  • Gastrointestinal disease
  • Orthopedic injury interfering with exercise
  • Use of certain medications (HRT, antihypertensives, diuretics, antiarythmia medications, antiresorptive agents, anabolic agents, hypoglycemic agents, and statins known to affect muscle i.e. Simvastatin and Zocor)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Overweight

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Stuart Phillips, Ph.D.

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2014

First Posted

December 11, 2014

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

December 11, 2014

Record last verified: 2014-11