Effect of Lactose, Fructose, Sucrose, Whey Protein, and Soy Protein on Substrate Absorption and Oxidation: a Pilot Study

February 8, 2011 updated by: United States Department of Agriculture (USDA)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Epidemiological research has shown that dairy products aid in weight loss and weight maintenance. Some evidence suggests that this effect is due to the whey component (which contains whey proteins and lactose) of milk. Previous work from our laboratory has demonstrated that chronic administration of whey protein concentrate results in decreased body fat and insulin concentration. Recent research (unpublished) from Castonguay and colleagues (University of Maryland, College Park, MD) has suggested that specific combinations of sucrose, maltose and lactose similarly alter body fat levels in rats. 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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Beltsville, Maryland, United States, 20705
        • USDA-ARS, Beltsville Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Department of Agriculture (USDA)

Investigators

  • Principal Investigator: David J Baer, Ph. D., USDA-ARS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 17, 2009

First Submitted That Met QC Criteria

July 17, 2009

First Posted (Estimate)

July 21, 2009

Study Record Updates

Last Update Posted (Estimate)

February 9, 2011

Last Update Submitted That Met QC Criteria

February 8, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2007-342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe