N/A
Completed N=20
A Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults
Source: ClinicalTrials.gov NCT02774668 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention — 5.5; 5.9 kg
Summary
The present study is designed to examine the effect of changes in body weight and related parameters associated with a commercially-available, low-carbohydrate diet plan. A parameter proposed to be studied here is the impact of fructose restriction and weight loss on serum uric acid concentrations and arterial stiffness.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention |
5.5; 5.9 | — |
| SECONDARY Arterial Stiffness Changes Between Baseline and 4 Weeks |
-0.4; -0.5 | — |
| SECONDARY Plasma Uric Acid Level Between Baseline and 4 Weeks. |
0.5; 0.04 | — |
| SECONDARY Change in Food Craving Questionnaire (FCI-II-State) at Baseline and 4 Weeks |
-0.4; -0.3 | — |
Eligibility Criteria
Inclusion Criteria
- Men and premenopausal women
- 30-55 years of age
- Sedentary lifestyle, defined as less than three sessions of activity per week, or sessions less than 20 minutes per occasion, or less than 5000 steps per day
- Must be able to speak, read, and write English (due to the small sample size and pilot nature of this study)
- Overweight/obese subjects with BMI 27.0 - 40.0 kg/m2 and any one of the following characteristics of the metabolic syndrome:
A. Serum HDL cholesterol 102 cm (40 in) and in women of >88 cm (35 in) E. Serum triglycerides (TG) ≥150 mg/dL (1.7 mmol/L).
Exclusion Criteria
- Abnormal thyroid function or known liver disease
- Diabetes or fasting glucose ≥ 125 mg/dL
- Use of medications that interfere with protein, carbohydrate or lipid metabolism (e.g., fish oil capsules)
- Occasional or regular tobacco use
- History of gout
- Uncontrolled hypertension
- Pregnant or peri-menopausal
- Vegetarian food restrictions (the diets consumed contain some meat, eggs and dairy)
- Alcohol intake: females > 70 g/wk, males >140 g/wk
- Moderate or vigorous-intensity physical activity, defined as more than 150 minutes per week of moderate-intensity, or 75 minutes a week of vigorous-intensity aerobic physical activity, or an equivalent combination of both.
Data sourced from ClinicalTrials.gov (NCT02774668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.