Substrate AbsorptionNCT00942513
Effect of Lactose, Fructose, Sucrose, Whey Protein, and Soy Protein on Substrate Absorption and Oxidation: a Pilot Study
A study testing trt 1, trt 2 and trt 3 in people with Substrate Absorption and Substrate Oxidation, run by United States Department of Agriculture (USDA) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substrate Absorption, Substrate Oxidation, Glucose Regulation
- What is being tested?
- trt 1, trt 2 and trt 3
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA-ARS, Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
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.
Read the 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.
- Being tested
- trt 1, trt 2, trt 3, trt 4, trt 5
- Keywords
- substrate absorption, substrate oxidation, glucose regulation, whey protein, soy protein, sucrose, fructose, lactose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substrate AbsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Department of Agriculture (USDA)
- Sponsor type
- US federal agency
- Investigators
- David J Baer, Ph. D., Principal investigator, United States Department of Agriculture (USDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942513
- Sponsor's protocol ID
- 2007-342
- Status last verified
- Feb 2011
- First submitted
- 17 Jul 2009
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactose, Fructose, Sucrose, Whey Protein, and Soy Protein on Substrate Absorption and Oxidation: a Pilot Study
- ClinicalTrials.gov ID
- NCT00942513
- Acronym / sponsor ID
- 2007-342
- Keywords
- substrate absorption, substrate oxidation, glucose regulation, whey protein, soy protein, sucrose, fructose, lactose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- United States Department of Agriculture (USDA)US federal agency
- First posted
- 21 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trt 1Fructose - 14 g; Lactose - 10 g; Sucrose - 16 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g | Other | – |
| trt 2Fructose - 30 g; Lactose - 10 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g | Other | – |
| trt 3Fructose - 24 g; Lactose - 8 g; Sucrose - 8 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g | Other | – |
| trt 4Fructose - 0 g; Lactose - 0 g; Sucrose - 40 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g | Other | – |
| trt 5Fructose - 0 g; Lactose - 0 g; Sucrose - 40 g; Starch - 40 g; Whey Protein Isolate - 0 g; Soy Protein Isolate -40 g | Other | – |
| trt 6Fructose - 0 g; Lactose - 40 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g | Other | – |
| trt 7Fructose - 0 g; Lactose - 40 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 0 g; Soy Protein Isolate -40 g | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Baer, Ph. D. principal investigator
United States Department of Agriculture (USDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trt 1, trt 2 and trt 3 in people with Substrate Absorption and Substrate Oxidation, run by United States Department of Agriculture (USDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2011.