NCT00942513

Brief Summary

Does the consumption of various combinations of mono and disaccharides (lactose, sucrose and fructose) and protein isolates (whey or soy) result in altered substrate absorption, substrate oxidation, and glucose regulation? This proposed research will provide data to determine the relative contribution of source of protein (whey vs soy) and carbohydrate (mono- and disaccharides) on the observed effects of dairy products on absorption, substrate oxidation and glucoregulation mechanisms that affect body composition.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2009

Completed
Last Updated

February 9, 2011

Status Verified

February 1, 2011

First QC Date

July 17, 2009

Last Update Submit

February 8, 2011

Conditions

Substrate AbsorptionSubstrate OxidationGlucose Regulation

Keywords

substrate absorptionsubstrate oxidationglucose regulationwhey proteinsoy proteinsucrosefructoselactose

Interventions

trt 1OTHER

Fructose - 14 g; Lactose - 10 g; Sucrose - 16 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g

trt 2OTHER

Fructose - 30 g; Lactose - 10 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g

trt 3OTHER

Fructose - 24 g; Lactose - 8 g; Sucrose - 8 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g

trt 4OTHER

Fructose - 0 g; Lactose - 0 g; Sucrose - 40 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g

trt 5OTHER

Fructose - 0 g; Lactose - 0 g; Sucrose - 40 g; Starch - 40 g; Whey Protein Isolate - 0 g; Soy Protein Isolate -40 g

trt 6OTHER

Fructose - 0 g; Lactose - 40 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g

trt 7OTHER

Fructose - 0 g; Lactose - 40 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 0 g; Soy Protein Isolate -40 g

Eligibility Criteria

Age25 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male.
  • BMI at least 20 and less than 38 kg/m2 and body weight \< 300 lbs.
  • Age 25 to 65 years at beginning of study.
  • Fasting glucose \< 126 mg/dL.
  • Blood pressure \< 160/100 mm Hg.
  • Total plasma cholesterol \< 280 mg/dL.
  • Nonsmokers or tobacco users (for at least 6 months prior to the start of the study.)

You may not qualify if:

  • History or presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes.
  • Type 2 diabetes requiring the use of oral antidiabetic agents or insulin.
  • History of eating disorders.
  • Volunteers who routinely participate in heavy exercise or volunteers who initiate an exercise program during the study.
  • Volunteers who have lost 10% of body weight within the last 12 months .
  • Volunteers who have been on Atkins, South Beach or similar diet in 3 months prior to start of study.
  • Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study).
  • Known (self-reported) allergy or adverse reaction to dairy products (including lactose) or soy.
  • Volunteers who consume whey or soy protein supplements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

MeSH Terms

Interventions

2-(9H-fluoren-9-yl)methoxycarbonylamino-3-ethoxy-N-tritylsuccinamic acid

Study Officials

  • David J Baer, Ph. D.

    United States Department of Agriculture (USDA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

July 17, 2009

First Posted

July 21, 2009

Last Updated

February 9, 2011

Record last verified: 2011-02

Locations

US(1)