Protein Intake & Insulin Action

NCT02004002 | Completed DMC

• 1 other identifier: WSP-201303080
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this proposal is to determine whether dietary protein restriction has beneficial effects on skeletal muscle insulin sensitivity and β-cell function in obese men and women.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Insulin sensitivity

  We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions.

  up to 8 wk dietary intervention

• total β-cell sensitivity index (Φtotal)

  The total β-cell sensitivity index assesses the insulin secretion response to changes in plasma glucose concentration following ingestion of a glucose drink.

  Before and after the 8 wk dietary intervention

Secondary Outcomes (1)

• Disposition index

  Before and after the 8 wk dietary intervention

Study Arms (2)

Weight maintenance with normal protein intake

ACTIVE COMPARATOR

Control group will consume 1.4 g protein/kg body wt/d; consistent with the average protein intake in the US population.

Behavioral: Weight maintenance with normal protein intake

Weight maintenance with protein restriction

EXPERIMENTAL

Protein restriction group will receive the Institute of Medicine RDA of 0.8 g protein/kg body wt/d.

Behavioral: Weight maintenance with protein restriction

Interventions

Weight maintenance with normal protein intake BEHAVIORAL

Control group will consume 1.4 g/kg/d of protein; consistent with the average protein intake in the US population.

Weight maintenance with normal protein intake

Weight maintenance with protein restriction BEHAVIORAL

Protein restriction group will receive the Institute of Medicine RDA of 0.8 g protein/kg body wt/d.

Weight maintenance with protein restriction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) between 30 and 50 kg/m2
• Subjects who are sedentary (\<1.5 h of exercise/week)
• Subjects with a high habitual protein intake (\>1.2 g/kg body mass/day)

You may not qualify if:

• Subjects with evidence of significant organ system dysfunction (e.g. diabetes, severe cardiovascular disease, hyperlipidemia, cirrhosis, hypogonadism, uncontrolled hypo- or hyperthyroidism; uncontrolled hypertension)
• Subjects with metal implants
• Individuals with cancer or cancer that has been in remission for \<5 years,
• Individuals with dementia,
• Individuals who use tobacco products,
• Subjects who are taking medications known to affect glucose metabolism (e.g., steroids),
• Subjects taking medications to control certain medical conditions (e.g., hypertension) will be included if the drug regimen has been stable for at least 6 months before entering the study and is not expected to change during the study.
• Women who are pregnant due to changes in body composition and decreases in insulin sensitivity caused by pregnancy

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Gordon Smith, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 12, 2016

Record last verified: 2016-10

Locations

US (1)