Breakfast Meal Replacement
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | June 2015 |
| End Date: | January 2016 |
Breakfast Meal Replacement Use on Body Composition and Health-related Quality of Life in Overweight Men and Women: a Randomized Controlled Trial
Purpose: To evaluate the effects of replacing breakfast with a high protein, high fat, high
fiber meal replacement in overweight individuals, on body composition.
Participants: Healthy, overweight and obese individuals (ages 18-45 yrs) with no history of
disease. Procedures (methods): In a randomized control intervention, subjects will complete
5 different testing sessions (pre-screening, 2 baseline testing sessions, and 2 post testing
sessions) as well as an 8 week intervention period. Pre-screening will include written
informed consent, health history questionnaire, nutrition analysis, and baseline
anthropometric measures. Baseline testing will be split into two sessions and include
measurements of resting metabolic rate (RMR), body composition, blood and saliva hormones,
mood, satiety, and health related quality of life questionnaires, and a cardiorespiratory
fitness assessment.
Subjects will be randomly assigned to treatment (8 week supplementation with meal
replacement to be taken at breakfast) and control groups (continue normal eating habits)
with 4 electronic correspondences throughout the supplementation period. All measures will
be repeated in two post-testing sessions.
fiber meal replacement in overweight individuals, on body composition.
Participants: Healthy, overweight and obese individuals (ages 18-45 yrs) with no history of
disease. Procedures (methods): In a randomized control intervention, subjects will complete
5 different testing sessions (pre-screening, 2 baseline testing sessions, and 2 post testing
sessions) as well as an 8 week intervention period. Pre-screening will include written
informed consent, health history questionnaire, nutrition analysis, and baseline
anthropometric measures. Baseline testing will be split into two sessions and include
measurements of resting metabolic rate (RMR), body composition, blood and saliva hormones,
mood, satiety, and health related quality of life questionnaires, and a cardiorespiratory
fitness assessment.
Subjects will be randomly assigned to treatment (8 week supplementation with meal
replacement to be taken at breakfast) and control groups (continue normal eating habits)
with 4 electronic correspondences throughout the supplementation period. All measures will
be repeated in two post-testing sessions.
Inclusion Criteria:
- Healthy, Overweight Men and Pre-Menopausal Women
- Participant agrees to maintain usual activity lifestyle
- Participant has a body mass index of ≥ 28 (men) and ≥25 (women) kg/m2 and/or %body
fat of ≥ 25%
- Participant has provided written and dated informed consent to participate in the
study
- Participant is willing and able to comply with the protocol
- Participant is apparently healthy and free from disease, as determined by a health
history questionnaire (diabetes, heart disease, kidney disease, cancer, thyroid
disorder, etc).
- Participant agrees to abstain from smoking, caffeine, tobacco, and alcohol before
testing days
- Participant has stated a goal of losing weight or improving body composition
Exclusion Criteria:
- Having a history of medical or surgical events that may significantly affect the
study outcome, including cardiovascular disease, metabolic, renal, hepatic, or
musculoskeletal disorders (i.e. anything influencing exercise ability).
- Participant is using, or has used one of the following dietary supplements within 8
weeks prior to enrollment: Meal replacement shakes, Whey Protein, Beta-alanine,
Creatine, beta-hydroxy beta methylbutyrate, Carnosine or Taurine
- Participant has lost or gained greater than ten pounds within the previous 3 months
- Participant is in, or has participated in another clinical trial within 4 weeks prior
to enrollment
- Participant had or currently has a self-identified eating disorder
- Participant is pregnant or plans to become pregnant during the duration of the study
- Participant has a known allergy or sensitivity to any ingredient in the test product
or placebo (determined from health history questionnaire)
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