OverweightFAMENCT02015377
Food, Adolescence, Mood, and Exercise
A study testing High sugar versus low sugar meals in people with Overweight and Obesity, run by University of Southern California at 1 site in United States.
Trial summary
The overall objective of FAME is to examine the metabolic and behavioral links between dietary intake and its subsequent effects on circulating appetite regulating hormones and physical activity levels in Hispanic and African American adolescents. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- High sugar versus low sugar meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Apr 2010
- 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 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children (9th - 11th grade, ~14-17yrs)
- Male and female
- Hispanic or African American
Who cannot join
- Diabetes
- Currently in weight loss or exercise program
- BMI < 85th percentile as defined by CDC growth curves
- Use of medications that influence body weight or SI
- Syndromes that influence body composition
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California Health Science Campus
Los Angeles, California, 90032
About this study
Official title: Food, Adolescence, Mood and Exercise
The overall objective of FAME is to examine the metabolic and behavioral links between dietary intake and its subsequent effects on circulating appetite regulating hormones and physical activity levels in Hispanic and African American adolescents.
Read the detailed description
Our major unifying hypothesis is that diets comprised of high sugar, energy dense, low fiber meals, are associated with a post-prandial metabolic, hormonal and psychosocial profile that promotes overeating and sedentary behavior. Specific Aims: (1) Compare the effects of a HIGH SUGAR, LOW FIBER (HSLF) meal versus a LOW SUGAR, HIGH FIBER (LSHF) meal on insulin dynamics, selected gut peptides, mood and levels of physical activity in minority adolescents, (2) Explore the effects of HSLF versus LSHF meals on post-prandial ad libitum food intake, (3) Explore differences in reaction to HSLF versus LSHF meals in lean and overweight adolescents and (4) Examine ethnic differences in meal responses between Hispanic and African American children. Research Design and Methods: We will employ a cross-over design with a 3-4 week washout period where normal weight and overweight African American and Hispanic youth come to our Observation Lab in a fasting state and consume high sugar and low sugar meals at separate visits in random order. Meal consumption will be followed by five hours of intensive observation in which we quantify real-time physical activity in laboratory setting that was designed to offer equally attractive choices for active or sedentary behaviors. After 5 hours, participants will be offered food platters with an array of food types and be invited to eat ad libitum. Subsequent energy and nutrient intake will be quantified. Rationale: This study is prompted by three observations: (1) The disproportionate levels of obesity and risk for type 2 diabetes and cardiovascular disease in Hispanic and African American children; (2) The rapid decline in physical activity during puberty especially in Hispanic and African American adolescents, and (3) Children, and particularly minority children, tend to have diets high in added sugars and low in fiber. Thus, it is imperative to improve our understanding of the interrelationships between dietary intake, physical activity and risk factors for type 2 diabetes and cardiovascular disease in minority youth, particularly during puberty, when physical activity levels significantly decline. Relevance to public health: This study will provide new information on the acute effects of meal composition on mood and subsequent choices of physical activity in normal weight, healthy overweight and insulin resistant overweight Hispanic and African American youth. Furthermore, we suggest that our findings may potentially lead to a better understanding the acute affects of poor nutritional choices on physical activity in minority adolescent populations at high risk for obesity, diabetes type 2, and other obesity-related diseases.
- Conditions
- Overweight, Obesity
- Being tested
- High sugar versus low sugar meals
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High sugar versus low sugar mealsOther
Participants visit our lab for two 8-hour periods with a minimum of two weeks washout in between. In one visit they receive high sugar low fiber meals, in the other they receive low sugar, high fiber meals. The order of meals is randomized
| Study group | Role | What they receive |
|---|---|---|
| High Sugar/Low Fiber (HSLF) meals | Experimental | Comparing the impact of High sugar/Low fiber (HSLF) meal versus Low Sugar/High Fiber meals (LSHF) on insulin and glucose profiles, gut hormones (ghrelin, amylin, leptin) free fatty acids, cortisol, mood (MOOD), meaning of physical activity (MEANPA), and physical activity engagement (PA) in overweight African American and Hispanic youth Receives: Other: High sugar versus low sugar meals |
| Low Sugar/High Fiber (LSHF) meals | Experimental | Comparing the impact of High sugar/Low fiber (HSLF) meal versus Low Sugar/High Fiber meals (LSHF) on insulin and glucose profiles, gut hormones (ghrelin, amylin, leptin) free fatty acids, cortisol, mood (MOOD), meaning of physical activity (MEANPA), and physical activity engagement (PA) in overweight African American and Hispanic youth Receives: Other: High sugar versus low sugar meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in physical activity as measured by accelerometer over an 8 hour in lab visit
Physical activity is measured by an actigraph accelerometer which is worn over the right hip on a belt.
Measured: physical activity is measured continuously by accelerometer worn on belt
Secondary outcomes (3)
Changes in blood glucose levels over 5 hours
On the day of the meal visits, participants arrived at the Observation Lab on campus at approximately 7:00 am after a 10-hour overnight fast. Topical anesthetic (EMLA) will immediately be placed on likely forearm IV sites. After every effort has been made to "break the ice" and develop rapport, a saline lock intravenous catheter was inserted and secured for stability in a forearm vein, not involving wrist or elbow joint in order to maximize motility during free activity. After a baseline blood draw (at -5 min), participants will be provided with a breakfast test meal. Blood is drawn every 30 minutes for 5 hours. The saline lock and blood draws were conducted by a trained and certified nurse.
Measured: Every 30 minutes for 5 hours
Changes in insulin over 5 hours
On the day of the meal visits, participants arrived at the Observation Lab on campus at approximately 7:00 am after a 10-hour overnight fast. Topical anesthetic (EMLA) will immediately be placed on likely forearm IV sites. After every effort has been made to "break the ice" and develop rapport, a saline lock intravenous catheter was inserted and secured for stability in a forearm vein, not involving wrist or elbow joint in order to maximize motility during free activity. After a baseline blood draw (at -5 min), participants will be provided with a breakfast test meal. Blood is drawn every 30 minutes for 5 hours. The saline lock and blood draws were conducted by a trained and certified nurse.
Measured: Blood was drawn every 30 minutes for 5 hours
Stress (objective and perceived) fluctuations over 5 hours
Every 30 minutes at the time of the blood draws, salivary cortisol was measured by salivette and perceived stress was measured by validated Visual Analogue Scale
Measured: Every 30 minutes for 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startSep 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Donna Spruijt-Metz, University of Southern California
- Investigators
- Donna Spruijt-Metz, Ph.D, Principal investigator, University of Southern CaliforniaMichael I Goran, Ph.D, Study director, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015377
- Sponsor's protocol ID
- FAME-HS-0700735
- Other IDs
- 5P60MD002254-04
- Acronym
- FAME
- Status last verified
- Mar 2017
- First submitted
- 9 Dec 2013
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food, Adolescence, Mood and Exercise
- ClinicalTrials.gov ID
- NCT02015377
- Acronym / sponsor ID
- FAME / FAME-HS-0700735
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Sep 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 19 Dec 2013 (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.
The overall objective of FAME is to examine the metabolic and behavioral links between dietary intake and its subsequent effects on circulating appetite regulating hormones and physical activity levels in Hispanic and African American adolescents.
Detailed description
Our major unifying hypothesis is that diets comprised of high sugar, energy dense, low fiber meals, are associated with a post-prandial metabolic, hormonal and psychosocial profile that promotes overeating and sedentary behavior. Specific Aims: (1) Compare the effects of a HIGH SUGAR, LOW FIBER (HSLF) meal versus a LOW SUGAR, HIGH FIBER (LSHF) meal on insulin dynamics, selected gut peptides, mood and levels of physical activity in minority adolescents, (2) Explore the effects of HSLF versus LSHF meals on post-prandial ad libitum food intake, (3) Explore differences in reaction to HSLF versus LSHF meals in lean and overweight adolescents and (4) Examine ethnic differences in meal responses between Hispanic and African American children. Research Design and Methods: We will employ a cross-over design with a 3-4 week washout period where normal weight and overweight African American and Hispanic youth come to our Observation Lab in a fasting state and consume high sugar and low sugar meals at separate visits in random order. Meal consumption will be followed by five hours of intensive observation in which we quantify real-time physical activity in laboratory setting that was designed to offer equally attractive choices for active or sedentary behaviors. After 5 hours, participants will be offered food platters with an array of food types and be invited to eat ad libitum. Subsequent energy and nutrient intake will be quantified. Rationale: This study is prompted by three observations: (1) The disproportionate levels of obesity and risk for type 2 diabetes and cardiovascular disease in Hispanic and African American children; (2) The rapid decline in physical activity during puberty especially in Hispanic and African American adolescents, and (3) Children, and particularly minority children, tend to have diets high in added sugars and low in fiber. Thus, it is imperative to improve our understanding of the interrelationships between dietary intake, physical activity and risk factors for type 2 diabetes and cardiovascular disease in minority youth, particularly during puberty, when physical activity levels significantly decline. Relevance to public health: This study will provide new information on the acute effects of meal composition on mood and subsequent choices of physical activity in normal weight, healthy overweight and insulin resistant overweight Hispanic and African American youth. Furthermore, we suggest that our findings may potentially lead to a better understanding the acute affects of poor nutritional choices on physical activity in minority adolescent populations at high risk for obesity, diabetes type 2, and other obesity-related diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Sugar/Low Fiber (HSLF) meals | Experimental | Other: High sugar versus low sugar mealsComparing the impact of High sugar/Low fiber (HSLF) meal versus Low Sugar/High Fiber meals (LSHF) on insulin and glucose profiles, gut hormones (ghrelin, amylin, leptin) free fatty acids, cortisol, mood (MOOD), meaning of physical activity (MEANPA), and physical activity engagement (PA) in overweight African American and Hispanic youth |
| Low Sugar/High Fiber (LSHF) meals | Experimental | Other: High sugar versus low sugar mealsComparing the impact of High sugar/Low fiber (HSLF) meal versus Low Sugar/High Fiber meals (LSHF) on insulin and glucose profiles, gut hormones (ghrelin, amylin, leptin) free fatty acids, cortisol, mood (MOOD), meaning of physical activity (MEANPA), and physical activity engagement (PA) in overweight African American and Hispanic youth |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children (9th - 11th grade, ~14-17yrs)
- Male and female
- Hispanic or African American
Key exclusion criteria (5 listed)
- Diabetes
- Currently in weight loss or exercise program
- BMI < 85th percentile as defined by CDC growth curves
- Use of medications that influence body weight or SI
- Syndromes that influence body composition
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 |
|---|---|---|
| High sugar versus low sugar mealsParticipants visit our lab for two 8-hour periods with a minimum of two weeks washout in between. In one visit they receive high sugar low fiber meals, in the other they receive low sugar, high fiber meals. The order of meals is randomized | Other | High Sugar/Low Fiber (HSLF) meals, Low Sugar/High Fiber (LSHF) meals |
Primary outcome
changes in physical activity as measured by accelerometer over an 8 hour in lab visit
Time frame: physical activity is measured continuously by accelerometer worn on belt
Physical activity is measured by an actigraph accelerometer which is worn over the right hip on a belt.
3 secondary outcomes
Changes in blood glucose levels over 5 hours
Time frame: Every 30 minutes for 5 hours
Changes in insulin over 5 hours
Time frame: Blood was drawn every 30 minutes for 5 hours
Stress (objective and perceived) fluctuations over 5 hours
Time frame: Every 30 minutes for 5 hours
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 31 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
Donna Spruijt-Metz, Ph.D principal investigator
University of Southern California
Michael I Goran, Ph.D study director
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High sugar versus low sugar meals in people with Overweight and Obesity, run by University of Southern California 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 3 inclusion and 5 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 31 Mar 2017. 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?
changes in physical activity as measured by accelerometer over an 8 hour in lab visit (time frame: physical activity is measured continuously by accelerometer worn on belt). 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 31 Mar 2017.