Effects of Diet Selection Based on Genetic Screening on Success to a Weight Loss Program (Curves3)

Texas A&M University

Status: Completed

Conditions: Diet Modification

Treatments: Other: Positive CIQ plus High Protein Diet; Other: Negative CIQ plus High Carbohydrate Diet; Other: Positive CIQ plus High Carbohydrate Diet; Other: Negative CIQ plus High Protein Diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03116711

IRB2013-0737F

Details and patient eligibility

About

The purpose of this study is to determine the effects of diet type selection based on response to a Carbohydrate Intolerance Questionnaire (CIQ) and genetic screening on success to a weight loss and exercise program.

Full description

The purpose of this study is to determine if stratification of individuals based on responses to a Carbohydrate Intolerance Questionnaire (CIQ), genetic screening, and/or DNA methylation affects weight loss success and/or health outcomes of women following the Curves moderate carbohydrate, high protein, low fat diet (30% carbohydrate, 45% protein, 25% fat) or the Curves carbohydrate restricted, high protein, moderate fat diet (20% carbohydrate, 45% protein, 35% fat).

Enrollment: 51 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The participant is an apparently healthy female
• The participant is between the ages of 18 and 60

Exclusion criteria

• The participant is pregnant or nursing, or plans to become pregnant during the next 12 months or has been pregnant in the past 12 months
• The participant has uncontrolled metabolic disorder including known electrolyte abnormalities; heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease
• The participant is currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications
• The participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB), anabolic/catabolic hormone levels (androstenedione, DHEA, etc.) or weight loss (e.g., ephedra, thermogenics, etc.) within the past three months
• The participant is willing to take participate in a regular moderate exercise program

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 4 patient groups

Positive CIQ plus High Carbohydrate Diet

Active Comparator group

Description:

Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet

Treatment:

Other: Positive CIQ plus High Carbohydrate Diet

Positive CIQ plus High Protein Diet

Active Comparator group

Description:

Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet

Treatment:

Other: Positive CIQ plus High Protein Diet

Negative CIQ plus High Carbohydrate Diet

Active Comparator group

Description:

Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet

Treatment:

Other: Negative CIQ plus High Carbohydrate Diet

Negative CIQ plus High Protein Diet

Active Comparator group

Description:

Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet

Treatment:

Other: Negative CIQ plus High Protein Diet