A Very High Fiber Diet Versus a Low-carbohydrate Diet for... | NCT01051674

Studies
A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss

NCT01051674

Sponsor

Loma Linda University

Status

Completed

Last Update Posted

Jul 1, 2014Estimated

Enrollment

173Actual

Phase

Phase 4

Conditions

Obesity
Type 2 Diabetes

Interventions

High fiber vs. low-carbohydrate diets

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jan 14, 2010

First Submission Date that Met QC Criteria

Jan 15, 2010

First Posted Date

Jan 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2014

Last Update Posted Date

Jul 1, 2014Estimated

Name	Class
Lifestyle Center of America	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

173Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High fiber diet	Experimental		Other: High fiber vs. low-carbohydrate diets
Low-carbohydrate diet	Experimental		Other: High fiber vs. low-carbohydrate diets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High fiber vs. low-carbohydrate diets	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight		1 year

Secondary Outcomes

Measure	Description	Time Frame
Lipid profiles		1 year
Gastrointestinal hormones		1 year
Waist circumference

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 30.0-42.0 kg/m2
English-speaking

Exclusion Criteria:

Pregnancy
Lactation
Acute or chronic infection
Type 1 diabetes
Participation in another trial
Active cancers
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Serena Tonstad, MD, PhD, MPH	Loma Linda University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Loma Linda U Medical Center Diabetes Treatment Center		Loma Linda	California	92354	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided