UCSD Get Fit, Be Fit Study



Status:Active, not recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - Any
Updated:2/23/2019
Start Date:April 4, 2018
End Date:January 2020

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Effects of Pistachio Consumption in a Weight Loss Intervention on Weight Change, Dietary Intake and Metabolic Factors

The purpose of the Get Fit, Be Fit Study is to examine the effect of incorporating pistachios
in an intensive 4-month cognitive-behavioral weight loss intervention in overweight and obese
men and women, to examine effects on metabolic factors, and to monitor and examine changes in
dietary intake and food choices during the intervention, in a randomized controlled study.

This study investigates whether pistachios help to promote weight loss and improve metabolic
and cardiovascular disease risk factors in 100 overweight or obese men and women who are
participating in a 4-month behavioral weight loss intervention. Participants will be assigned
to a cognitive-behavioral weight loss intervention and will be provided either general
dietary advice as a component of the behavioral curriculum or prescribed an individualized
pistachio-enriched reduced-energy diet plan. The pistachio-enriched diet will prescribe 42
g/day of pistachios, or approximately 13-20% (averaging 18%) of energy intake across a range
of 1200-1800 kcal/day. Dietary intake will be assessed at three time points (baseline, one
month, and four months) to examine changes in dietary intake and food choices that may be
indicative of compensatory intake in response to regular nut consumption. Results from this
study will contribute to understanding the role of pistachios in weight control, including
further knowledge of the metabolic factors linked to chronic disease, and will expand
knowledge of how pistachios in the diet may contribute to the prevention and management of
obesity.

Inclusion Criteria:

- Men and Women who reside in the San Diego area

- Age 21 and older

- BMI ≥ 27.0 kg/m2 and ≤40 kg/m2

- No known allergy to tree nuts

- Non-diabetic

- Non-smoker

- Willing and able to participate in clinic visits, group sessions, and telephone and
Internet communications at specified intervals

- Able to provide data through questionnaires and by telephone

- Willing to maintain contact with the investigators for 6 months

- Willing to allow blood collections

- Capable of performing a simple test for assessing cardiopulmonary fitness

- Willing and able to be physically active

Exclusion Criteria:

- Inability to participate in physical activity because of severe disability

- Inability to restrict consumption of nuts for four months

- History or presence of a co-morbid disease for which diet modification and increased
physical activity may be contraindicated

- Self-reported pregnancy or breastfeeding or planning a pregnancy within the next year

- Currently actively involved in another diet intervention study or organized weight
loss program

- Having a history or presence of a significant psychiatric disorder or any other
condition that, in the investigator's judgment, would interfere with participation in
the trial.

- Prior to enrollment

- Subjects will be screened for diabetes and considered ineligible with a fasting blood
glucose ≥125 mg/dL.
We found this trial at
1
site
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Phone: 858-822-6162
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