HealthyCARBNCT00622661
Carbohydrates and Related Biomarkers
A study testing Low Glycemic Load Diet and High Glycemic Load Diet in people with Healthy and Overweight, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This study is designed to investigate associations of low- and high-glycemic load diets with biomarkers of hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight
- What is being tested?
- Low Glycemic Load Diet and High Glycemic Load Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jul 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and female subjects
- Between the ages of 18 to 45
- BMI between 18.5 kg/m2 to 24. 9 kg/m2 (normal weight) and between 28.0 kg/m2 to 39.9 kg/m2 (overweight)
- Willingness to refrain from alcohol during the study
- Able to come to the FHCRC in Seattle every weekday night for dinner
Who cannot join
- Younger than 18 years of age or older than 45 years of age.
- Do not fit into one of the study weight groups (normal weight and overweight): BMI < 18.5 kg/m2 or > 40.0 kg/m2, and between 25.0 kg/m2and 27.9 kg/m2
- Have diseases that are treated by diet and/or medications including but not limited to diabetes, kidney disease, heart disease
- Taking prescription medications every day (this includes women taking birth-control pills, shots, patch or IUD with hormones)
- Diagnosed with or treated for cancer within the previous five years (except those with a diagnosis and/or treatment of non-melanomatous skin cancer are eligible)
- Currently pregnant or breastfeeding or planning a pregnancy in the next 3 months.
Show all 10Show fewer
- Using any tobacco products on a daily basis (cigarettes, pipes, cigars, chewing tobacco).
- Using recreational drugs
- Drinking the following amount of alcohol almost every day: 2 or more cans/bottles of beer OR 2 or more glasses of wine OR 3 or more ounces of hard liquor.
- Inability (e.g., food allergy or intolerances) or unwillingness to consume the foods that are part of the feeding study diet.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: A Feeding Study to Examine the Effect of Glycemic Load and Obesity on Cancer Biomarkers
This study is designed to investigate associations of low- and high-glycemic load diets with biomarkers of hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk.
Read the detailed description
This is a randomized, crossover feeding study conducted in normal weight and overweight individuals. Participants will be given all their food to eat and drink (except water) for two 28-day feeding periods (a total of 56 days). The diets will be carefully controlled and energy intake will be regulated to maintain weight stability for each participant. The two feeding periods will be separated by a 28 day "washout" period when participants will eat their own food. Dinner will be eaten at the Hutchinson Center Monday through Friday. Each evening, breakfast, lunch and snacks will be brought home for the next day. On Friday evenings all the food will be taken home for the weekend.
Samples of blood will be collected after an overnight fast at the beginning and the end of each feeding period. All urine will be collected for 24 hours at the end of each feeding period. A number of questionnaires will also be completed during each diet period. A small stool sample will be collected in your own home, before the first feeding period, and once during each feeding period. The stool sample collection is optional. One can decide not to provide a stool sample and still participate in the study.
- Conditions
- Healthy, Overweight
- Being tested
- Low Glycemic Load Diet, High Glycemic Load Diet
- Keywords
- Glycemic response, Glycemic index, Obesity, Carbohydrates, Insulin, Blood glucose
- Medical subject headings
- Overweight, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Glycemic Load DietOther
consume both high and low glycemic load diets for 28 days each
High Glycemic Load DietOther
consume both high and low glycemic load diets for 28 days each
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Normal weight Receives: Other: Low Glycemic Load Diet; Other: High Glycemic Load Diet |
| 2 | Other | Overweight Receives: Other: Low Glycemic Load Diet; Other: High Glycemic Load Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoints of the study will be a set of inter-related biomarkers for hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk.
Measured: two 4-week feeding periods (56 days total)
Secondary outcomes (1)
Questionnaires will generate data on how these diets may influence mood or depression, sleep habits, and measures of appetite and satiety.
Measured: two 4-week feeding periods (56 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startJun 2006
- Primary completionJul 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Marian Neuhouser, RD, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622661
- Sponsor's protocol ID
- PHS 2059.00
- Other IDs
- NIH/NCI U54 CA 116847, IR 6105
- Acronym
- CARB
- Status last verified
- Jan 2012
- First submitted
- 14 Feb 2008
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hullar MA, Kahsai O, Curtis KR, Navarro SL, Zhang Y, Randolph TW, Levy L, Shojaie A, Kratz M, Neuhouser ML, Lampe PD, Raftery D, Lampe JW. Metabolic plasticity of the gut microbiome in response to diets differing in glycemic load in a randomized, crossover, controlled feeding study. Am J Clin Nutr. 2025 Sep;122(3):780-792. doi: 10.1016/j.ajcnut.2025.06.026. Epub 2025 Jul 5.
PubMed 40619005Dibay Moghadam S, Navarro SL, Shojaie A, Randolph TW, Bettcher LF, Le CB, Hullar MA, Kratz M, Neuhouser ML, Lampe PD, Raftery D, Lampe JW. Plasma lipidomic profiles after a low and high glycemic load dietary pattern in a randomized controlled crossover feeding study. Metabolomics. 2020 Nov 20;16(12):121. doi: 10.1007/s11306-020-01746-3.
PubMed 33219392Navarro SL, Tarkhan A, Shojaie A, Randolph TW, Gu H, Djukovic D, Osterbauer KJ, Hullar MA, Kratz M, Neuhouser ML, Lampe PD, Raftery D, Lampe JW. Plasma metabolomics profiles suggest beneficial effects of a low-glycemic load dietary pattern on inflammation and energy metabolism. Am J Clin Nutr. 2019 Oct 1;110(4):984-992. doi: 10.1093/ajcn/nqz169.
PubMed 31432072Ginos BNR, Navarro SL, Schwarz Y, Gu H, Wang D, Randolph TW, Shojaie A, Hullar MAJ, Lampe PD, Kratz M, Neuhouser ML, Raftery D, Lampe JW. Circulating bile acids in healthy adults respond differently to a dietary pattern characterized by whole grains, legumes and fruits and vegetables compared to a diet high in refined grains and added sugars: A randomized, controlled, crossover feeding study. Metabolism. 2018 Jun;83:197-204. doi: 10.1016/j.metabol.2018.02.006. Epub 2018 Feb 17.
PubMed 29458053Breymeyer KL, Lampe JW, McGregor BA, Neuhouser ML. Subjective mood and energy levels of healthy weight and overweight/obese healthy adults on high-and low-glycemic load experimental diets. Appetite. 2016 Dec 1;107:253-259. doi: 10.1016/j.appet.2016.08.008. Epub 2016 Aug 6.
PubMed 27507131Barton S, Navarro SL, Buas MF, Schwarz Y, Gu H, Djukovic D, Raftery D, Kratz M, Neuhouser ML, Lampe JW. Targeted plasma metabolome response to variations in dietary glycemic load in a randomized, controlled, crossover feeding trial in healthy adults. Food Funct. 2015 Sep;6(9):2949-56. doi: 10.1039/c5fo00287g.
PubMed 26165375Runchey SS, Pollak MN, Valsta LM, Coronado GD, Schwarz Y, Breymeyer KL, Wang C, Wang CY, Lampe JW, Neuhouser ML. Glycemic load effect on fasting and post-prandial serum glucose, insulin, IGF-1 and IGFBP-3 in a randomized, controlled feeding study. Eur J Clin Nutr. 2012 Oct;66(10):1146-52. doi: 10.1038/ejcn.2012.107. Epub 2012 Aug 15.
PubMed 22892437Chang KT, Lampe JW, Schwarz Y, Breymeyer KL, Noar KA, Song X, Neuhouser ML. Low glycemic load experimental diet more satiating than high glycemic load diet. Nutr Cancer. 2012;64(5):666-73. doi: 10.1080/01635581.2012.676143. Epub 2012 May 7.
PubMed 22564018Neuhouser ML, Schwarz Y, Wang C, Breymeyer K, Coronado G, Wang CY, Noar K, Song X, Lampe JW. A low-glycemic load diet reduces serum C-reactive protein and modestly increases adiponectin in overweight and obese adults. J Nutr. 2012 Feb;142(2):369-74. doi: 10.3945/jn.111.149807. Epub 2011 Dec 21.
PubMed 22190020
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feeding Study to Examine the Effect of Glycemic Load and Obesity on Cancer Biomarkers
- ClinicalTrials.gov ID
- NCT00622661
- Acronym / sponsor ID
- CARB / PHS 2059.00
- Conditions
- Healthy, Overweight
- Keywords
- Glycemic response, Glycemic index, Obesity, Carbohydrates, Insulin, Blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 25 Feb 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.
This study is designed to investigate associations of low- and high-glycemic load diets with biomarkers of hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk.
Detailed description
This is a randomized, crossover feeding study conducted in normal weight and overweight individuals. Participants will be given all their food to eat and drink (except water) for two 28-day feeding periods (a total of 56 days). The diets will be carefully controlled and energy intake will be regulated to maintain weight stability for each participant. The two feeding periods will be separated by a 28 day "washout" period when participants will eat their own food. Dinner will be eaten at the Hutchinson Center Monday through Friday. Each evening, breakfast, lunch and snacks will be brought home for the next day. On Friday evenings all the food will be taken home for the weekend.
Samples of blood will be collected after an overnight fast at the beginning and the end of each feeding period. All urine will be collected for 24 hours at the end of each feeding period. A number of questionnaires will also be completed during each diet period. A small stool sample will be collected in your own home, before the first feeding period, and once during each feeding period. The stool sample collection is optional. One can decide not to provide a stool sample and still participate in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Low Glycemic Load Diet, Other: High Glycemic Load DietNormal weight |
| 2 | Other | Other: Low Glycemic Load Diet, Other: High Glycemic Load DietOverweight |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males and female subjects
- Between the ages of 18 to 45
- BMI between 18.5 kg/m2 to 24. 9 kg/m2 (normal weight) and between 28.0 kg/m2 to 39.9 kg/m2 (overweight)
- Willingness to refrain from alcohol during the study
- Able to come to the FHCRC in Seattle every weekday night for dinner
Key exclusion criteria (10 listed)
- Younger than 18 years of age or older than 45 years of age.
- Do not fit into one of the study weight groups (normal weight and overweight): BMI < 18.5 kg/m2 or > 40.0 kg/m2, and between 25.0 kg/m2and 27.9 kg/m2
- Have diseases that are treated by diet and/or medications including but not limited to diabetes, kidney disease, heart disease
- Taking prescription medications every day (this includes women taking birth-control pills, shots, patch or IUD with hormones)
- Diagnosed with or treated for cancer within the previous five years (except those with a diagnosis and/or treatment of non-melanomatous skin cancer are eligible)
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 |
|---|---|---|
| Low Glycemic Load Dietconsume both high and low glycemic load diets for 28 days each | Other | 1, 2 |
| High Glycemic Load Dietconsume both high and low glycemic load diets for 28 days each | Other | 1, 2 |
Primary outcome
The primary endpoints of the study will be a set of inter-related biomarkers for hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk.
Time frame: two 4-week feeding periods (56 days total)
1 secondary outcome
Questionnaires will generate data on how these diets may influence mood or depression, sleep habits, and measures of appetite and satiety.
Time frame: two 4-week feeding periods (56 days)
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 5 Jan 2012.
- Derived from this study: PubMed 40619005Hullar MA, Kahsai O, Curtis KR, Navarro SL, Zhang Y, Randolph TW, Levy L, Shojaie A, Kratz M, Neuhouser ML, Lampe PD, Raftery D, Lampe JW. Metabolic plasticity of the gut microbiome in response to diets differing in glycemic load in a randomized, crossover, controlled feeding study. Am J Clin Nutr. 2025 Sep;122(3):780-792. doi: 10.1016/j.ajcnut.2025.06.026. Epub 2025 Jul 5.
- Derived from this study: PubMed 33219392Dibay Moghadam S, Navarro SL, Shojaie A, Randolph TW, Bettcher LF, Le CB, Hullar MA, Kratz M, Neuhouser ML, Lampe PD, Raftery D, Lampe JW. Plasma lipidomic profiles after a low and high glycemic load dietary pattern in a randomized controlled crossover feeding study. Metabolomics. 2020 Nov 20;16(12):121. doi: 10.1007/s11306-020-01746-3.
- Derived from this study: PubMed 31432072Navarro SL, Tarkhan A, Shojaie A, Randolph TW, Gu H, Djukovic D, Osterbauer KJ, Hullar MA, Kratz M, Neuhouser ML, Lampe PD, Raftery D, Lampe JW. Plasma metabolomics profiles suggest beneficial effects of a low-glycemic load dietary pattern on inflammation and energy metabolism. Am J Clin Nutr. 2019 Oct 1;110(4):984-992. doi: 10.1093/ajcn/nqz169.
- Derived from this study: PubMed 29458053Ginos BNR, Navarro SL, Schwarz Y, Gu H, Wang D, Randolph TW, Shojaie A, Hullar MAJ, Lampe PD, Kratz M, Neuhouser ML, Raftery D, Lampe JW. Circulating bile acids in healthy adults respond differently to a dietary pattern characterized by whole grains, legumes and fruits and vegetables compared to a diet high in refined grains and added sugars: A randomized, controlled, crossover feeding study. Metabolism. 2018 Jun;83:197-204. doi: 10.1016/j.metabol.2018.02.006. Epub 2018 Feb 17.
- Derived from this study: PubMed 27507131Breymeyer KL, Lampe JW, McGregor BA, Neuhouser ML. Subjective mood and energy levels of healthy weight and overweight/obese healthy adults on high-and low-glycemic load experimental diets. Appetite. 2016 Dec 1;107:253-259. doi: 10.1016/j.appet.2016.08.008. Epub 2016 Aug 6.
- Derived from this study: PubMed 26165375Barton S, Navarro SL, Buas MF, Schwarz Y, Gu H, Djukovic D, Raftery D, Kratz M, Neuhouser ML, Lampe JW. Targeted plasma metabolome response to variations in dietary glycemic load in a randomized, controlled, crossover feeding trial in healthy adults. Food Funct. 2015 Sep;6(9):2949-56. doi: 10.1039/c5fo00287g.
- Derived from this study: PubMed 22892437Runchey SS, Pollak MN, Valsta LM, Coronado GD, Schwarz Y, Breymeyer KL, Wang C, Wang CY, Lampe JW, Neuhouser ML. Glycemic load effect on fasting and post-prandial serum glucose, insulin, IGF-1 and IGFBP-3 in a randomized, controlled feeding study. Eur J Clin Nutr. 2012 Oct;66(10):1146-52. doi: 10.1038/ejcn.2012.107. Epub 2012 Aug 15.
- Derived from this study: PubMed 22564018Chang KT, Lampe JW, Schwarz Y, Breymeyer KL, Noar KA, Song X, Neuhouser ML. Low glycemic load experimental diet more satiating than high glycemic load diet. Nutr Cancer. 2012;64(5):666-73. doi: 10.1080/01635581.2012.676143. Epub 2012 May 7.
- Derived from this study: PubMed 22190020Neuhouser ML, Schwarz Y, Wang C, Breymeyer K, Coronado G, Wang CY, Noar K, Song X, Lampe JW. A low-glycemic load diet reduces serum C-reactive protein and modestly increases adiponectin in overweight and obese adults. J Nutr. 2012 Feb;142(2):369-74. doi: 10.3945/jn.111.149807. Epub 2011 Dec 21.
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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.
Marian Neuhouser, RD, PhD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Glycemic Load Diet and High Glycemic Load Diet in people with Healthy and Overweight, run by Fred Hutchinson Cancer Center 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 5 inclusion and 10 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 5 Jan 2012. 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?
The primary endpoints of the study will be a set of inter-related biomarkers for hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk. (time frame: two 4-week feeding periods (56 days total)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00622661, which also lists 9 linked publications.
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 5 Jan 2012.