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

This study has been completed.
Sponsor:
Information provided by:
USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT00942513
First received: July 17, 2009
Last updated: February 8, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Substrate Absorption
Substrate Oxidation
Glucose Regulation
Other: trt 1
Other: trt 2
Other: trt 3
Other: trt 4
Other: trt 5
Other: trt 6
Other: trt 7

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Effect of Lactose, Fructose, Sucrose, Whey Protein, and Soy Protein on Substrate Absorption and Oxidation: a Pilot Study

Resource links provided by NLM:


Further study details as provided by USDA Beltsville Human Nutrition Research Center:

Enrollment: 9
Intervention Details:
    Other: trt 1
    Fructose - 14 g; Lactose - 10 g; Sucrose - 16 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g
    Other: trt 2
    Fructose - 30 g; Lactose - 10 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g
    Other: trt 3
    Fructose - 24 g; Lactose - 8 g; Sucrose - 8 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g
    Other: trt 4
    Fructose - 0 g; Lactose - 0 g; Sucrose - 40 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g
    Other: trt 5
    Fructose - 0 g; Lactose - 0 g; Sucrose - 40 g; Starch - 40 g; Whey Protein Isolate - 0 g; Soy Protein Isolate -40 g
    Other: trt 6
    Fructose - 0 g; Lactose - 40 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g
    Other: trt 7
    Fructose - 0 g; Lactose - 40 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 0 g; Soy Protein Isolate -40 g
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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942513

Locations
United States, Maryland
USDA-ARS, Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
Investigators
Principal Investigator: David J Baer, Ph. D. USDA-ARS
  More Information

No publications provided

Responsible Party: David J. Baer, Ph. D., Principal Investigator, USDA_ARS
ClinicalTrials.gov Identifier: NCT00942513     History of Changes
Other Study ID Numbers: 2007-342
Study First Received: July 17, 2009
Last Updated: February 8, 2011
Health Authority: United States: Federal Government

Keywords provided by USDA Beltsville Human Nutrition Research Center:
substrate absorption
substrate oxidation
glucose regulation
whey protein
soy protein
sucrose
fructose
lactose

ClinicalTrials.gov processed this record on July 31, 2014