An interventional study of "Grab-and-Go" meal plan and "Jump-Start" meal plan in Metabolic Syndrome, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Basic science
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.
It is well know that consumption of a calorically-restricted diet helps people lose weight. Such a diet with low carbohydrate lowers the serum uric acid concentration which is a factor associated with obesity and also represents a particular metabolic risk in women compared to men. The present weight loss study will determine whether women benefit more than men to short-term weight loss occurring during restriction of simple sugars.
Specifically, this study is designed to cause weight loss acutely through consumption of a diet that is restricted in calorie and simple sugars. Both men and women will be studied and their results compared to determine whether women benefit more with respect to arterial stiffness. Upon finishing the four-week diet intervention, body weight and blood lipids will be assessed two and four weeks later to compare the longer term effect on blood pressure.
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A. Serum HDL cholesterol \<40 mg/dL (1 mmol/L) in men and \<50 mg/dL (1.3 mmol/L) in women B. Blood pressure ≥130/85 mmHg C. Fasting plasma glucose ≥100 mg/dL (5.6 mmol/L) D. Waist circumference in men of >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:
The intervention of this arm is to use a "Grab-and-Go" meal plan. This meal plan provides Atkins shakes and bars for breakfast, lunch, and snacks for 2 weeks. For dinner the subject is given a freshly-prepared meal. Upon finishing the 2-week provided food phase, the subject will consume a self-prepared meal of similar nutrient composition at home for another 2 weeks. For the next four weeks while he/she is still enrolled in the study, he/she will have his/her options for food choices which are not controlled for the study.
Other: "Grab-and-Go" meal plan
The intervention of this arm is to use a "Jump Start" meal plan. This meal plan provides Atkins frozen meals at breakfast, lunch and dinner for 2 weeks and these meals are supplemented with fresh salads and vegetables. Upon finishing the 2-week provided food phase, the subject will consume a self-prepared meal of similar nutrient composition at home for another 2 weeks. For the next four weeks while he/she is still enrolled in the study, he/she will have his/her options for food choices which are not controlled for the study.
Other: "Jump-Start" meal plan
The "Grab-and-Go" meal plan will provide Atkins shakes and bars for breakfast, lunch, and snacks. For dinner, the participant will receive a freshly-prepared meal. There will be no difference in terms of calories or nutrient composition between "Grab-and-Go" meal plan versus "Jump-Start" meal plan. The amount of weight loss caused by these two meal plans is not expected to differ.
The "Jump-Start" plan will provide Atkins frozen meals at breakfast, lunch and dinner and these meals will be supplemented with fresh salads and vegetables. There will be no difference in terms of calories or nutrient composition between "Grab-and-Go" meal plan versus "Jump-Start" meal plan. The amount of weight loss caused by these two meal plans is not expected to differ.
Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention
For statistical analysis, the body weight is measured at baseline and after 4 weeks after consumption of a calorie-restricted, low-carbohydrate diet.
Time frame: Change of body weight over 4 weeks of dietary intervention
Arterial Stiffness Changes Between Baseline and 4 Weeks
Pulse wave velocity, a non-invasive indicator of arterial stiffness will be assessed at the baseline testing and 4 weeks after the start of the dietary intervention.
Time frame: Arterial stiffness will be measured at baseline and 4 weeks
Plasma Uric Acid Level Between Baseline and 4 Weeks.
A fasting blood sample will be collected at baseline, 4 weeks after the start of the dietary intervention to measure plasma uric acid level.
Time frame: Plasma uric acid level will be measured at baseline and 4 weeks
Change in Food Craving Questionnaire (FCI-II-State) at Baseline and 4 Weeks
Food craving questionnaire (FCI-II-State) will be administrated at baseline visit and the end of 4-week after dietary change. Cravings are assessed from 0 (no cravings: "Not at all") to 5 (high cravings: "Extremely/Always") for each of the five subscales measures including high-fat foods, sweets, carbohydrates/starches, fast-food fats, and fruits/vegetables. In addition, the scores for each of the subscales were averaged to produce a total cravings measure (also assessed from 0-5).
Time frame: Questionnaires about food cravings will be administrated at baseline visit and 4 weeks after the start of the meal plan
Subjects were recruited in the local Columbia, MO area from April 2016 through August 2016
| Milestone | "Grab-and-Go" Meal Plan | "Jump-Start" Meal Plan |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
For statistical analysis, the body weight is measured at baseline and after 4 weeks after consumption of a calorie-restricted, low-carbohydrate diet.
| kg | "Grab-and-Go" Meal Plan | "Jump-Start" Meal Plan |
|---|---|---|
| Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention | 5.5 ± 1.6 | 5.9 ± 2.6 |
Pulse wave velocity, a non-invasive indicator of arterial stiffness will be assessed at the baseline testing and 4 weeks after the start of the dietary intervention.
| m/s | "Grab-and-Go" Meal Plan | "Jump-Start" Meal Plan |
|---|---|---|
| Arterial Stiffness Changes Between Baseline and 4 Weeks | -0.4 ± 0.8 | -0.5 ± 0.7 |
A fasting blood sample will be collected at baseline, 4 weeks after the start of the dietary intervention to measure plasma uric acid level.
| mg/dL | "Grab-and-Go" Meal Plan | "Jump-Start" Meal Plan |
|---|---|---|
| Plasma Uric Acid Level Between Baseline and 4 Weeks. | 0.5 ± 1.4 | 0.04 ± 1.2 |
Food craving questionnaire (FCI-II-State) will be administrated at baseline visit and the end of 4-week after dietary change. Cravings are assessed from 0 (no cravings: "Not at all") to 5 (high cravings: "Extremely/Always") for each of the five subscales measures including high-fat foods, sweets, carbohydrates/starches, fast-food fats, and fruits/vegetables. In addition, the scores for each of the subscales were averaged to produce a total cravings measure (also assessed from 0-5).
| score on a scale | "Grab-and-Go" Meal Plan | "Jump-Start" Meal Plan |
|---|---|---|
| Change in Food Craving Questionnaire (FCI-II-State) at Baseline and 4 Weeks | -0.4 ± 0.6 | -0.3 ± 0.5 |
Collected over Adverse event data were collected from the time the subjects entered baseline testing, during their consumption of the diets, and through the follow-up testing. Because the diets were whole foods, commonly consumed we did not expect many adverse events.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| "Grab-and-Go" Meal Plan | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| "Jump-Start" Meal Plan | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | "Grab-and-Go" Meal Plan | "Jump-Start" Meal Plan | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | "Grab-and-Go" Meal Plan | "Jump-Start" Meal Plan | Total |
|---|---|---|---|
| Mean | 41.2 ± 7.9 | 39.2 ± 9.0 | 40.2 ± 8.3 |
| Sex: Female, Male(Participants) | "Grab-and-Go" Meal Plan | "Jump-Start" Meal Plan | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 5 | 5 | 10 |
| Race (NIH/OMB)(Participants) | "Grab-and-Go" Meal Plan | "Jump-Start" Meal Plan | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 9 | 9 | 18 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | "Grab-and-Go" Meal Plan | "Jump-Start" Meal Plan | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
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University of Missouri-Columbia