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Resistant Starch Insulin Sensitivity Trial (RESIST)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01027325
First received: December 3, 2009
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

The alarming increase in the prevalence of obesity is a cause of great concern given its association with many adverse health conditions, including insulin resistance and type 2 diabetes, which are associated with increased cardiovascular disease (CVD) risk. The primary objective of this project is to identify effective dietary strategies, focused on carbohydrate quantity and starch digestibility, to improve outcome variables associated with CVD risk in insulin resistant individuals who express components of the atherogenic lipoprotein phenotype (ALP). Current dietary guidelines emphasize substitution of carbohydrate calories for total and saturated fat calories for prevention and management of chronic disease. Yet, we and others have shown that high-carbohydrate diets increase the expression of the ALP, characterized by increased plasma triglycerides, reduced HDL cholesterol, and increased levels of small, dense LDL particles, and that this phenotype is reversed by moderate carbohydrate restriction. We have also shown that expression of stearoyl coenzymeA desaturase (SCD), an enzyme involved in triglyceride synthesis, is reduced with carbohydrate restriction and that this change is correlated with plasma triglyceride response. While carbohydrate restriction is effective for management of ALP, the role of starch quality has not been addressed. Furthermore, there has been no study of the effects of resistant vs. digestible starches incorporated into high- vs. lower carbohydrate diets. Since isolated reports suggest that increased intake of resistant starch lowers plasma triglycerides and postprandial insulinemia, we hypothesize that starch quality is an important determinant of components of ALP, and that this may be mediated in part by reduced adipose tissue SCD expression. Aim 1 and of this proposal will address this hypothesis by a controlled dietary intervention in 52 insulin resistant men and women in which changes in plasma lipids, lipoproteins and lipogenic gene expression will be determined after substituting resistant starch for digestible starch in a high- vs. lower-carbohydrate diet. In Aim 2, the fasting and postprandial glucose and insulin responses to a resistant vs. digestible starch meal will be measured to test the hypothesis that starch digestibility improves glycemic and insulinemic control in a way that relates to diet-induced changes in plasma lipids and lipoproteins.


Condition Intervention
Healthy
Cardiovascular Disease
Atherogenic Dyslipidemia
Insulin Resistance
Other: Dietary Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effects of Resistant Starch on Lipid and Glucose Metabolism in Insulin Resistance

Resource links provided by NLM:


Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Triglycerides [ Time Frame: 2 weeks, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • LDL subfractions [ Time Frame: 2 weeks, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total cholesterol [ Time Frame: 2 weeks, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: 2, 4, 8 weeks ] [ Designated as safety issue: No ]
  • apolipoproteins B, AI [ Time Frame: 2, 4, 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: June 2010
Study Completion Date: November 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High CHO/Low Amylose
55% Carbohydrate (11.2% Amylose, 26.3% Amylopectin) 20% Protein 25% Fat
Other: Dietary Intervention
Starch digestibility and carbohydrate quantity
Other Names:
  • Dietary carbohydrate
  • Resistant starch
  • Amylose
  • Amylopectin
  • Lipids
Experimental: Low Carbohydrate/Hi Amylose
40% Carbohydrate (26.3% Amylose, 11.2% Amylopectin) 20% Protein 40% Fat
Other: Dietary Intervention
Starch digestibility and carbohydrate quantity
Other Names:
  • Dietary carbohydrate
  • Resistant starch
  • Amylose
  • Amylopectin
  • Lipids
Experimental: High CHO/High Amylose
55% Carbohydrate (26.3% Amylose, 11.2% Amylopectin) 20% Protein 25% Fat
Other: Dietary Intervention
Starch digestibility and carbohydrate quantity
Other Names:
  • Dietary carbohydrate
  • Resistant starch
  • Amylose
  • Amylopectin
  • Lipids
Experimental: Low Carbohydrate/Low Amylose
40% Carbohydrate (11.2% Amylose, 26.3% Amylopectin) 20% Protein 40% Fat
Other: Dietary Intervention
Starch digestibility and carbohydrate quantity
Other Names:
  • Dietary carbohydrate
  • Resistant starch
  • Amylose
  • Amylopectin
  • Lipids
Active Comparator: Baseline
40% Carbohydrate 20% Protein 40% Fat
Other: Dietary Intervention
Starch digestibility and carbohydrate quantity
Other Names:
  • Dietary carbohydrate
  • Resistant starch
  • Amylose
  • Amylopectin
  • Lipids

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women ≥ 20 years
  • Blood pressure less than 150/90. If on three separate clinic visits blood pressure remains above this level, a subject will be referred to his or her physician for treatment.
  • Body mass index (BMI) ≥ 20 and ≤ 35 kg/m2.
  • Non-smoking and does not use nicotine products or recreational drugs.
  • Agrees to consume no alcohol or dietary supplements during the study.
  • Total cholesterol and LDL cholesterol <95th percentile for sex and age.
  • Fasting triglycerides <500mg/dl.
  • HOMA-IR ≥ 50th percentile for sex.
  • Fasting blood sugar (FBS) < 126 mg/dl.
  • Hematocrit ≥ 36%.
  • At least 3 months of a weight stable state. During the study, subjects will be required to maintain their body weight within ± 3% (up to a maximum change of 5 lbs) of their initial weight over the course of any consecutive two weeks.
  • For women of childbearing potential, two barrier methods of contraception must be used throughout the study and urine pregnancy B-hCG will be done at screen (v1) and at all "A" visits (v2a, 3a, 4a). Subjects who become pregnant will no longer be allowed to continue the study.
  • Women will be considered post-menopausal if ≥ 3 years since last menses or no menses for 1-3 years and plasma FSH elevated into postmenopausal range.
  • Subjects who cannot complete the requirements of the study for reasons determined by the investigator (i.e. non-accessible veins for blood drawing, inability to keep clinic appointments) will not be able to participate in the study.

Exclusion Criteria:

  • History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years.
  • Taking drugs known to affect lipid metabolism, blood thinning agents or hormones
  • Abnormal thyroid stimulating hormone (TSH) levels
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027325

Locations
United States, California
Cholesterol Research Center
Berkeley, California, United States, 94705
Children's Hospital Oakland Research Institute
Oakland, California, United States, 94609
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Investigators
Principal Investigator: Ronald M Krauss, MD Children's Hospital & Research Center Oakland
Principal Investigator: Nathalie Bergeron, PhD Children's Hospital Oakland Research Institiute
  More Information

No publications provided

Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01027325     History of Changes
Other Study ID Numbers: 1RC1DK086472-01, 1RC1DK086472-01
Study First Received: December 3, 2009
Last Updated: January 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital & Research Center Oakland:
Resistant Starch
Amylose
Amylopectin
LDL subclasses
Dietary carbohydrate
Postprandial insulinemia

Additional relevant MeSH terms:
Cardiovascular Diseases
Dyslipidemias
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 27, 2014