Metabolic Syndrome
Conditions
Keywords
gender, arterial stiffness, blood pressure, weight loss, uric acid
Brief 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.
Detailed description
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.
Interventions
OTHERGrab-and-Go 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.
OTHERJump-Start meal plan
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.
Sponsors
Robert C. Atkins Foundation
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and premenopausal women 2. 30-55 years of age 3. 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 4. Must be able to speak, read, and write English (due to the small sample size and pilot nature of this study) 5. 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 \<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
1. Abnormal thyroid function or known liver disease 2. Diabetes or fasting glucose ≥ 125 mg/dL 3. Use of medications that interfere with protein, carbohydrate or lipid metabolism (e.g., fish oil capsules) 4. Occasional or regular tobacco use 5. History of gout 6. Uncontrolled hypertension 7. Pregnant or peri-menopausal 8. Vegetarian food restrictions (the diets consumed contain some meat, eggs and dairy) 9. Alcohol intake: females \> 70 g/wk, males \>140 g/wk 10. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention | Change of body weight over 4 weeks 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Stiffness Changes Between Baseline and 4 Weeks | Arterial stiffness will be measured at 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. |
| Plasma Uric Acid Level Between Baseline and 4 Weeks. | Plasma uric acid level will be measured at 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. |
| Change in Food Craving Questionnaire (FCI-II-State) at Baseline and 4 Weeks | Questionnaires about food cravings will be administrated at baseline visit and 4 weeks after the start of the meal plan | 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). |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited in the local Columbia, MO area from April 2016 through August 2016
Pre-assignment details
Subjects underwent screening to assess meeting the eligibility requirements and then were assigned to one of the diet groups. 64 men and women were assessed for eligibility to find the 20 eligible subjects.
Participants by arm
| Arm | Count |
|---|---|
| Grab-and-Go Meal Plan 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.
Grab-and-Go 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. | 10 |
| Jump-Start 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.
Jump-Start meal plan: 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Jump-Start Meal Plan | Total | Grab-and-Go Meal Plan |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 20 Participants | 10 Participants |
| Age, Continuous | 39.2 years STANDARD_DEVIATION 9 | 40.2 years STANDARD_DEVIATION 8.3 | 41.2 years STANDARD_DEVIATION 7.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 18 Participants | 9 Participants |
| Region of Enrollment United States | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grab-and-Go Meal Plan | Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention | 5.5 kg | Standard Deviation 1.6 |
| Jump-Start Meal Plan | Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention | 5.9 kg | Standard Deviation 2.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grab-and-Go Meal Plan | Arterial Stiffness Changes Between Baseline and 4 Weeks | -0.4 m/s | Standard Deviation 0.8 |
| Jump-Start Meal Plan | Arterial Stiffness Changes Between Baseline and 4 Weeks | -0.5 m/s | Standard Deviation 0.7 |
Secondary
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
Population: One subject in the Jump-start arm did not fill out a cravings questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grab-and-Go Meal Plan | Change in Food Craving Questionnaire (FCI-II-State) at Baseline and 4 Weeks | -0.4 score on a scale | Standard Deviation 0.6 |
| Jump-Start Meal Plan | Change in Food Craving Questionnaire (FCI-II-State) at Baseline and 4 Weeks | -0.3 score on a scale | Standard Deviation 0.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grab-and-Go Meal Plan | Plasma Uric Acid Level Between Baseline and 4 Weeks. | 0.5 mg/dL | Standard Deviation 1.4 |
| Jump-Start Meal Plan | Plasma Uric Acid Level Between Baseline and 4 Weeks. | 0.04 mg/dL | Standard Deviation 1.2 |