Weight Loss and Abdominal Fat Responses to Different Diet Compositions

NCT01034046 | Unknown DMC

• 1 other identifier: B08/09-031
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effectiveness of two different reduced calorie diets that have different combinations of carbohydrate, fat, and protein content in 2 groups of study participants: insulin sensitive participants and insulin resistant participants. The hypothesis of the study is that people with high and low levels of insulin resistance may respond differently to different diet compositions in a real-world environment using meals that are commonly available.

Conditions

Obesity; Insulin Resistance; Metabolic Syndrome

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in weight in kg

  24 weeks

Secondary Outcomes (1)

• Change in visceral fat via bioimpedance

  24 weeks

Study Arms (2)

Insulin Sensitive Study Participants

ACTIVE COMPARATOR

Insulin sensitive subjects stratified using fasting insulin levels.

Other: Low Carbohydrate Diet; Other: Low Fat Diet

Insulin Resistant Study Subjects

ACTIVE COMPARATOR

Insulin resistant subjects stratified using fasting insulin levels.

Other: Low Carbohydrate Diet; Other: Low Fat Diet

Interventions

Low Carbohydrate Diet OTHER

Low carbohydrate diet (45% carbohydrate, 35% fat and 20% protein diet) administered utilizing meal replacements.

Insulin Resistant Study Subjects; Insulin Sensitive Study Participants

Low Fat Diet OTHER

Low fat diet (60% carbohydrate, 20% fat and 20% protein diet) administered utilizing meal replacements.

Insulin Resistant Study Subjects; Insulin Sensitive Study Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females between 18 and 65 years of age.
• BMI 30-40 kg/m2
• Stable weight within 10 lb (+/-) for last 2 months

You may not qualify if:

• Pregnant or lactating.
• Must not currently be part of a structured weight loss program
• Taking a medication for diabetes (such as insulin, metformin, glyburide, glipizide, Byetta, pioglitazone, or rosiglitazone) or a medication such as systemic glucocorticoids that are known to affect blood sugar or blood insulin.
• Beck Depression Inventory (BDI Score \>19 and/or positively endorses the suicide question on the BDI-II)
• Taking any chronic medication that has not had a stable dose for 1 month or longer.
• Diabetes mellitus defined as a fasting glucose ≥ 126 mg/dL on screening.
• Taking medications or dietary supplements that cause weight gain or weight loss (eg. antipsychotics (Seroquel, Zyprexa, and Risperdal) and/or anorectics).
• Clinically significant laboratory abnormalities at the opinion of the investigators.
• History of Bariatric Surgery
• A history of:
• Type 2 diabetes, type 1 diabetes, or diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly.
• Liver disease, such as cirrhosis, or chronic active hepatitis B or C.
• Use of investigational drugs within 30 days of visit 1
• A pacemaker.
• Hospitalization for depression in the past 6 months, history of moderate to severe major depression.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead
• Jenny Craig, Inc.: collaborator

Study Sites (1)

Center for Nutrition and Metabolism at the University of Nevada School of Medicine, Reno

Reno, Nevada, 89557, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance; Metabolic Syndrome

Interventions

Diet, Carbohydrate-Restricted; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Raymond A Plodkowski, MD

  University of Nevada School of Medicine, Reno

  PRINCIPAL INVESTIGATOR

• Sachiko T St. Jeor, PhD, RD

  University of Nevada School of Medicine, Reno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 30, 2010

Record last verified: 2009-12

Locations

US (1)