ElderlyNCT00798408
The Body's Response to Food Intake in Older Adults
A study testing Fluid Supplement and Solid Supplement in people with Elderly, run by Purdue University at 1 site in United States.
Trial summary
We propose to critically evaluate the effects of energy-yielding fluids and solids on acute appetite variables, daily food intake, and specific endocrine and metabolic response to food in the elderly. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- Fluid Supplement and Solid Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jan 2008
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range: 60 years and older
- Body mass index between 20-29 kg/m2
- Weight stable (< 2 kg weight change within last 6 months)
- Non-smoking
- Constant habitual activity patterns within last 3 months
- Clinically normal blood profiles (specifically, normal liver and kidney function; normal complete blood count (non-anemic); fasting blood glucose <110 mg/dl)
Show all 11Show fewer
- Not taking medications known to influence appetite or metabolism
- Non-diabetic
- Resistive exercise training (≤2 times a week) based on reported physical activity levels (questionnaire)
- Active fitness level (≤3, 30-minute aerobic exercise sessions/week)
- Confirmation of acceptability of eating the study test foods (solids and fluids)
Who cannot join
- Age: <60 years
- Body mass index: outside of the 20-29 kg/m2 range
- Gained or lost > 4.5 kg within the last 6 months
- Smoker (currently or within the last year)
- Intermittently been involved in a diet and/or exercise program within the last 3 months
- Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
Show all 12Show fewer
- Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
- Abnormal heart function (interpreted by a cardiologist) and assessed (for study exclusion) by our study physician, Arthur Rosen, MD
- Clinically diagnosed as diabetic
- Did not perform resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
- Perform ≥ 2, 30-minute aerobic exercise sessions/week (currently or within the last 3 months) based on physical activity levels (questionnaire)
- Study foods are found to be unacceptable for consumption by the subject
Trial locations and contacts
1 site in 1 country.
About this study
We propose to critically evaluate the effects of energy-yielding fluids and solids on acute appetite variables, daily food intake, and specific endocrine and metabolic response to food in the elderly. The results of these studies will provide further evidence to support that nutrition may provide safe and effective non-pharmacological therapies to counter the compromised regulation of energy balance experienced by many elderly people.
- Conditions
- Elderly
- Being tested
- Fluid Supplement, Solid Supplement
- Keywords
- Evaluate the effects of energy-yielding fluids and solids endocrine and metabolic response to food in the elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid SupplementDietary supplement
The fluid food items will contain 25% of each individual's total energy intake estimated from the gender-specific Harris Benedict equation*1.5 activity factor, volume, and amount and type of macronutrients
Solid SupplementDietary supplement
The solid food items will contain 25% of each individual's total energy intake estimated from the gender-specific Harris Benedict equation*1.5 activity factor, volume, and amount and type of macronutrients
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will maintain current physical activity and take a fluid supplement. Receives: Dietary Supplement: Fluid Supplement |
| 2 | Experimental | Participants will maintain current physical activity and take a solid supplement. Receives: Dietary Supplement: Solid Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify the acute effects of fluid and solid foods on post-prandial (post-meal) appetite and food intake at the next eating occasion in untrained older men and women
Measured: 3 weeks
Secondary outcomes (1)
Quantify the contribution of selected satiety factors (glucose, insulin, CCK, ghrelin, and GLP-1) and post-prandial energy expenditure to the differential appetitive responses to fluid versus solid foods in untrained older men and women
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startFeb 2006
- Primary completionOct 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne W Campbell, Ph.D., Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798408
- Sponsor's protocol ID
- 0-0509003024
- Other IDs
- NIH R01 AG021911-0102
- Status last verified
- Dec 2009
- First submitted
- 25 Nov 2008
- Last updated
- 24 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Body's Response to Food Intake in Older Adults
- ClinicalTrials.gov ID
- NCT00798408
- Acronym / sponsor ID
- 0-0509003024
- Conditions
- Elderly
- Keywords
- Evaluate the effects of energy-yielding fluids and solids endocrine and metabolic response to food in the elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 26 Nov 2008 (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.
We propose to critically evaluate the effects of energy-yielding fluids and solids on acute appetite variables, daily food intake, and specific endocrine and metabolic response to food in the elderly. The results of these studies will provide further evidence to support that nutrition may provide safe and effective non-pharmacological therapies to counter the compromised regulation of energy balance experienced by many elderly people.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Fluid SupplementParticipants will maintain current physical activity and take a fluid supplement. |
| 2 | Experimental | Dietary Supplement: Solid SupplementParticipants will maintain current physical activity and take a solid supplement. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age range: 60 years and older
- Body mass index between 20-29 kg/m2
- Weight stable (< 2 kg weight change within last 6 months)
- Non-smoking
- Constant habitual activity patterns within last 3 months
Key exclusion criteria (12 listed)
- Age: <60 years
- Body mass index: outside of the 20-29 kg/m2 range
- Gained or lost > 4.5 kg within the last 6 months
- Smoker (currently or within the last year)
- Intermittently been involved in a diet and/or exercise program within the last 3 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 |
|---|---|---|
| Fluid SupplementThe fluid food items will contain 25% of each individual's total energy intake estimated from the gender-specific Harris Benedict equation*1.5 activity factor, volume, and amount and type of macronutrients | Dietary supplement | 1 |
| Solid SupplementThe solid food items will contain 25% of each individual's total energy intake estimated from the gender-specific Harris Benedict equation*1.5 activity factor, volume, and amount and type of macronutrients | Dietary supplement | 2 |
Primary outcome
Quantify the acute effects of fluid and solid foods on post-prandial (post-meal) appetite and food intake at the next eating occasion in untrained older men and women
Time frame: 3 weeks
1 secondary outcome
Quantify the contribution of selected satiety factors (glucose, insulin, CCK, ghrelin, and GLP-1) and post-prandial energy expenditure to the differential appetitive responses to fluid versus solid foods in untrained older men and women
Time frame: 3 weeks
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 24 Sep 2013.
Related trials for Elderly
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
Wayne W Campbell, Ph.D. principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid Supplement and Solid Supplement in people with Elderly, run by Purdue University 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 11 inclusion and 12 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 24 Sep 2013. 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.
What does the primary outcome measure?
Quantify the acute effects of fluid and solid foods on post-prandial (post-meal) appetite and food intake at the next eating occasion in untrained older men and women (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
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 24 Sep 2013.