Calorie Restriction, Protein Supplementation and Metabolic Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-03-31

Brief Summary

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The purpose of this study is to determine whether consuming additional protein during calorie restriction induced weight loss has beneficial or harmful effects on multi-organ (liver, muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal women.

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Detailed Description

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Conditions

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Obesity Menopause Osteoporosis Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Weight maintenance

Weight maintenance with normal protein intake

Group Type NO_INTERVENTION

No interventions assigned to this group

Weight loss with normal protein intake

Group Type ACTIVE_COMPARATOR

Weight loss with normal protein intake

Intervention Type BEHAVIORAL

Goal of 8 to 10% weight loss while consuming the recommended daily allowance of protein (i.e, 0.8 grams of protein per kg body weight per day).

Weight loss with protein supplementation

Group Type EXPERIMENTAL

Weight loss with protein supplementation

Intervention Type BEHAVIORAL

Goal of 8 to 10% weight loss while consuming 150% of the recommended daily allowance of protein (i.e., 1.2 grams of protein per kg body weight per day).

Interventions

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Weight loss with normal protein intake

Goal of 8 to 10% weight loss while consuming the recommended daily allowance of protein (i.e, 0.8 grams of protein per kg body weight per day).

Intervention Type BEHAVIORAL

Weight loss with protein supplementation

Goal of 8 to 10% weight loss while consuming 150% of the recommended daily allowance of protein (i.e., 1.2 grams of protein per kg body weight per day).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Obese with body mass index (BMI) between 30 and 50 kg/m2
* Postmenopausal
* Sedentary (i.e., less than 1.5 hours of exercise per week)

Exclusion Criteria

* Individuals with diabetes and/or uncontrolled hypertension
* Individuals with hepatitis B and/or C
* Individuals who smoke
* Individuals with an allergy to whey protein

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes