ObesityPhase 4NCT01051674
A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss
A Phase 4 study testing High fiber vs. low-carbohydrate diets in people with Obesity and Type 2 Diabetes, run by Loma Linda University at 1 site in United States.
Trial summary
Using a 2x2 complete factorial design, approximately 140 obese men and women who may or may not have type 2 diabetes will be randomized to one of two conditions (70 in each condition): (a) a high fiber diet, or (b) a low-carbohydrate diet. Participants will be instructed to follow their assigned diets for 1 year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- High fiber vs. low-carbohydrate diets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2011
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 30.0-42.0 kg/m2
- English-speaking
Who cannot join
- Pregnancy
- Lactation
- Acute or chronic infection
- Type 1 diabetes
- Participation in another trial
- Active cancers
Show all 12Show fewer
- Currently using Byetta
- Currently on weight loss medication
- Weight loss of more than 4 lbs. within the last 3 months
- Vegan
- Active eating disorder
- Gastrointestinal problems that may be worsened by a high fiber intake
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda U Medical Center Diabetes Treatment Center
Loma Linda, California, 92354
About this study
Official title: A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss in Obese Individuals With or Without Type 2 Diabetes
Using a 2x2 complete factorial design, approximately 140 obese men and women who may or may not have type 2 diabetes will be randomized to one of two conditions (70 in each condition): (a) a high fiber diet, or (b) a low-carbohydrate diet. Participants will be instructed to follow their assigned diets for 1 year. Outcome measures of interest will include participants' BMI, waist circumference, blood lipids (total, HDL, and LDL cholesterol, and triglycerides), C-reactive protein, and gastrointestinal peptides. Participants will be recruited from the Loma Linda and San Bernardino city area in southern California.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- High fiber vs. low-carbohydrate diets
- Keywords
- Obesity, Type 2 diabetes, Fiber, Dietary fiber, Low-carbohydrate diet, High protein diet
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fiber vs. low-carbohydrate dietsOther
High fiber diet involves at least 40 grams of dietary fiber or more per day for women and at least 50 grams of dietary fiber per day for men. Low-carbohydrate diet involves less than 120 grams of carbohydrate per day for both men and women.
| Study group | Role | What they receive |
|---|---|---|
| High fiber diet | Experimental | Not described Receives: Other: High fiber vs. low-carbohydrate diets |
| Low-carbohydrate diet | Experimental | Not described Receives: Other: High fiber vs. low-carbohydrate diets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 1 year
Secondary outcomes (7)
Lipid profiles
Measured: 1 year
Gastrointestinal hormones
Measured: 1 year
Waist circumference
Measured: 1 year
C-reactive protein
Measured: 1 year
Blood glucose
Measured: 1 year
Serum insulin
Measured: 1 year
Hemoglobin A1c
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Lifestyle Center of America
- Responsible party
- Sponsor
- Investigators
- Serena Tonstad, MD, PhD, MPH, Study chair, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051674
- Sponsor's protocol ID
- 59217
- Status last verified
- Jun 2014
- First submitted
- 14 Jan 2010
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss in Obese Individuals With or Without Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01051674
- Acronym / sponsor ID
- 59217
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- Obesity, Type 2 diabetes, Fiber, Dietary fiber, Low-carbohydrate diet, High protein diet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Lifestyle Center of America
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Jan 2010 (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.
Using a 2x2 complete factorial design, approximately 140 obese men and women who may or may not have type 2 diabetes will be randomized to one of two conditions (70 in each condition): (a) a high fiber diet, or (b) a low-carbohydrate diet. Participants will be instructed to follow their assigned diets for 1 year. Outcome measures of interest will include participants' BMI, waist circumference, blood lipids (total, HDL, and LDL cholesterol, and triglycerides), C-reactive protein, and gastrointestinal peptides. Participants will be recruited from the Loma Linda and San Bernardino city area in southern California.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fiber diet | Experimental | Other: High fiber vs. low-carbohydrate diets |
| Low-carbohydrate diet | Experimental | Other: High fiber vs. low-carbohydrate diets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 30.0-42.0 kg/m2
- English-speaking
Key exclusion criteria (12 listed)
- Pregnancy
- Lactation
- Acute or chronic infection
- Type 1 diabetes
- Participation in another trial
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 fiber vs. low-carbohydrate dietsHigh fiber diet involves at least 40 grams of dietary fiber or more per day for women and at least 50 grams of dietary fiber per day for men. Low-carbohydrate diet involves less than 120 grams of carbohydrate per day for both men and women. | Other | High fiber diet, Low-carbohydrate diet |
Primary outcome
Weight
Time frame: 1 year
7 secondary outcomes
Lipid profiles
Time frame: 1 year
Gastrointestinal hormones
Time frame: 1 year
Waist circumference
Time frame: 1 year
C-reactive protein
Time frame: 1 year
Blood glucose
Time frame: 1 year
Serum insulin
Time frame: 1 year
Hemoglobin A1c
Time frame: 1 year
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 1 Jul 2014.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Serena Tonstad, MD, PhD, MPH study chair
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High fiber vs. low-carbohydrate diets in people with Obesity and Type 2 Diabetes, run by Loma Linda 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 2 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 1 Jul 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Weight (time frame: 1 year). 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 1 Jul 2014.