PrediabetesSTARCHNCT01708694
Role of Slowly Digesible Starch on Diabetes Risk Factors
A study testing Amylose and Amylopectin in people with Prediabetes, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of a slowly digesting starch on gut bacteria, sugar and fat metabolism, hunger hormones, and body fat in people with pre-diabetes. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Amylose and Amylopectin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2016
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a body mass index between 30 and 44.9 kg/m2
- Are 35-65 years of age
- Have pre-diabetes, which means impaired fasting glucose (IFG)
- Are willing to complete nutritional and activity questionnaires and 2-3 weeks of baseline testing
- Are willing to enroll in the 3-month intervention and maintain the same level of exercise during the study
- Are willing to maintain weight throughout the study
Who cannot join
- Have evidence of cardiovascular disease, diabetes, symptomatic cholelithiasis (gallstones), or cancer
- Have a fasting blood glucose less than 100 mg/dL or greater than 125 mg/dL
- Have an average screening blood pressure > 150/100 mm Hg
- Are a pre-menopausal woman but do not have a regular menstrual cycle
- Are pregnant or breastfeeding
- Chronically use medications including diuretics, steroids, and adrenergic-stimulating agents
Show all 14Show fewer
- Have emotional problems such as clinical depression or other diagnosed psychological conditions
- Use hormonal contraceptives, oral or parenteral glucocorticoids, or any other medication known to influence glucose or insulin homeostasis (balance), within 1 month of study
- Have a clinically significant gastrointestinal malabsorption syndrome, chronic diarrhea, or use antibiotics within one month of study
- Have abnormal laboratory markers (e.g., elevated potassium levels, hemoglobin or hematocrit below the lower limit of normal)
- Chronically consume alcohol (> 4 servings per day) or actively smoke cigarettes (> 1/4 pack per day)
- Are on any chronic medication that has not had a stable dose for 1 month or longer
- Are required to perform of any kind of heavy physical activity
- Have metal objects in the body, such as a pacemaker, metal pins, bullet, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Role of Slowly Digesible Starch on Diabetes Risk Factors In Pre-diabetic People
The purpose of this study is to determine the effect of a slowly digesting starch on gut bacteria, sugar and fat metabolism, hunger hormones, and body fat in people with pre-diabetes.
Read the detailed description
In a double blind randomized controlled clinical trial, the investigators will test the effect of slowly digesting starch (amylose) versus a placebo starch (amylopectin) on risk factors for type 2 diabetes. For the study, about 95 obese participants (ages 35-65) with pre-diabetes (impaired fasting glucose) will consume a yogurt containing about 45 g of either the experimental or placebo starch daily for 3 months. The investigators will test the hypothesis that, compared to controls, a daily intake of 45 g of amylose for 3 months will improve risk factors for the development of type 2 diabetes (insulin sensitivity and secretion) by decreasing ectopic fat depots and decreasing inflammation in parallel with a change in colonic microbial populations.
- Conditions
- Prediabetes
- Being tested
- Amylose, Amylopectin
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmyloseDietary supplement
One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.
AmylopectinDietary supplement
The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Starch | Placebo comparator | Yogurt with about 45 g/day of placebo starch (amylopectin). Receives: Dietary Supplement: Amylose |
| Experimental Starch | Experimental | Yogurt with about 45 g/day of slowly digestible starch (amylose). Receives: Dietary Supplement: Amylopectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity and Secretion
Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).
Measured: 3 months
Secondary outcomes (4)
Body Composition
DXA and MRS will be performed to measure body composition (adipose, muscle, bone mineral content) and to measure hepatic and intramyocellular lipids, respectively.
Measured: 3 months
Gut Microbiota
Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.
Measured: 3 months
Satiety
Satiety hormones will be measured following ingestion of a standardized smoothie (Standard Meal Test). Satiety will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.
Measured: 3 months
Hunger
Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Ravussin, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708694
- Sponsor's protocol ID
- PBRC 12009
- Other IDs
- R01DK092575
- Acronym
- STARCH
- Status last verified
- Dec 2017
- First submitted
- 10 Oct 2012
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
White U, Peterson CM, Beyl RA, Martin CK, Ravussin E. Resistant Starch Has No Effect on Appetite and Food Intake in Individuals with Prediabetes. J Acad Nutr Diet. 2020 Jun;120(6):1034-1041. doi: 10.1016/j.jand.2020.01.017. Epub 2020 Apr 9.
PubMed 32280055Peterson CM, Beyl RA, Marlatt KL, Martin CK, Aryana KJ, Marco ML, Martin RJ, Keenan MJ, Ravussin E. Effect of 12 wk of resistant starch supplementation on cardiometabolic risk factors in adults with prediabetes: a randomized controlled trial. Am J Clin Nutr. 2018 Sep 1;108(3):492-501. doi: 10.1093/ajcn/nqy121.
PubMed 30010698Marlatt KL, White UA, Beyl RA, Peterson CM, Martin CK, Marco ML, Keenan MJ, Martin RJ, Aryana KJ, Ravussin E. Role of resistant starch on diabetes risk factors in people with prediabetes: Design, conduct, and baseline results of the STARCH trial. Contemp Clin Trials. 2018 Feb;65:99-108. doi: 10.1016/j.cct.2017.12.005. Epub 2017 Dec 21.
PubMed 29274892
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Slowly Digesible Starch on Diabetes Risk Factors In Pre-diabetic People
- ClinicalTrials.gov ID
- NCT01708694
- Acronym / sponsor ID
- STARCH / PBRC 12009
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Oct 2012 (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 purpose of this study is to determine the effect of a slowly digesting starch on gut bacteria, sugar and fat metabolism, hunger hormones, and body fat in people with pre-diabetes.
Detailed description
In a double blind randomized controlled clinical trial, the investigators will test the effect of slowly digesting starch (amylose) versus a placebo starch (amylopectin) on risk factors for type 2 diabetes. For the study, about 95 obese participants (ages 35-65) with pre-diabetes (impaired fasting glucose) will consume a yogurt containing about 45 g of either the experimental or placebo starch daily for 3 months. The investigators will test the hypothesis that, compared to controls, a daily intake of 45 g of amylose for 3 months will improve risk factors for the development of type 2 diabetes (insulin sensitivity and secretion) by decreasing ectopic fat depots and decreasing inflammation in parallel with a change in colonic microbial populations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Starch | Placebo comparator | Dietary Supplement: AmyloseYogurt with about 45 g/day of placebo starch (amylopectin). |
| Experimental Starch | Experimental | Dietary Supplement: AmylopectinYogurt with about 45 g/day of slowly digestible starch (amylose). |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a body mass index between 30 and 44.9 kg/m2
- Are 35-65 years of age
- Have pre-diabetes, which means impaired fasting glucose (IFG)
- Are willing to complete nutritional and activity questionnaires and 2-3 weeks of baseline testing
- Are willing to enroll in the 3-month intervention and maintain the same level of exercise during the study
Key exclusion criteria (14 listed)
- Have evidence of cardiovascular disease, diabetes, symptomatic cholelithiasis (gallstones), or cancer
- Have a fasting blood glucose less than 100 mg/dL or greater than 125 mg/dL
- Have an average screening blood pressure > 150/100 mm Hg
- Are a pre-menopausal woman but do not have a regular menstrual cycle
- Are pregnant or breastfeeding
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 |
|---|---|---|
| AmyloseOne group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months. | Dietary supplement | Placebo Starch |
| AmylopectinThe second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months. | Dietary supplement | Experimental Starch |
Primary outcome
Insulin Sensitivity and Secretion
Time frame: 3 months
Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).
4 secondary outcomes
Body Composition
Time frame: 3 months
Gut Microbiota
Time frame: 3 months
Satiety
Time frame: 3 months
Hunger
Time frame: 3 months
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 15 Dec 2017.
- Derived from this study: PubMed 32280055White U, Peterson CM, Beyl RA, Martin CK, Ravussin E. Resistant Starch Has No Effect on Appetite and Food Intake in Individuals with Prediabetes. J Acad Nutr Diet. 2020 Jun;120(6):1034-1041. doi: 10.1016/j.jand.2020.01.017. Epub 2020 Apr 9.
- Derived from this study: PubMed 30010698Peterson CM, Beyl RA, Marlatt KL, Martin CK, Aryana KJ, Marco ML, Martin RJ, Keenan MJ, Ravussin E. Effect of 12 wk of resistant starch supplementation on cardiometabolic risk factors in adults with prediabetes: a randomized controlled trial. Am J Clin Nutr. 2018 Sep 1;108(3):492-501. doi: 10.1093/ajcn/nqy121.
- Derived from this study: PubMed 29274892Marlatt KL, White UA, Beyl RA, Peterson CM, Martin CK, Marco ML, Keenan MJ, Martin RJ, Aryana KJ, Ravussin E. Role of resistant starch on diabetes risk factors in people with prediabetes: Design, conduct, and baseline results of the STARCH trial. Contemp Clin Trials. 2018 Feb;65:99-108. doi: 10.1016/j.cct.2017.12.005. Epub 2017 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amylose and Amylopectin in people with Prediabetes, run by Pennington Biomedical Research 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 6 inclusion and 14 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 15 Dec 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. Some participants in this study may receive a placebo. 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?
Insulin Sensitivity and Secretion (time frame: 3 months). 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 NCT01708694, which also lists 3 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 15 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.