Back to resultsA Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"Grab-and-Go" meal plan
"Jump-Start" meal plan
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Syndrome focused on measuring gender, arterial stiffness, blood pressure, weight loss, uric acid
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 <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:
- 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.
Sites / Locations
- University of Missouri
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
"Grab-and-Go" meal plan
"Jump-Start" meal plan
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
Full Information
NCT ID
NCT02774668
First Posted
May 10, 2016
Last Updated
March 28, 2023
Sponsor
University of Missouri-Columbia
Collaborators
Robert C. Atkins Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02774668
Brief Title
A Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults
Official Title
A Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
Robert C. Atkins Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
gender, arterial stiffness, blood pressure, weight loss, uric acid
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"Grab-and-Go" meal plan
Arm Type
Active Comparator
Arm Description
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.
Arm Title
"Jump-Start" meal plan
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
"Grab-and-Go" meal plan
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
"Jump-Start" meal plan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention
Description
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
Secondary Outcome Measure Information:
Title
Arterial Stiffness Changes Between Baseline and 4 Weeks
Description
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
Title
Plasma Uric Acid Level Between Baseline and 4 Weeks.
Description
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
Title
Change in Food Craving Questionnaire (FCI-II-State) at Baseline and 4 Weeks
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 <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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiong Hu, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29746789
Citation
Syed-Abdul MM, Hu Q, Jacome-Sosa M, Padilla J, Manrique-Acevedo C, Heimowitz C, Parks EJ. Effect of carbohydrate restriction-induced weight loss on aortic pulse wave velocity in overweight men and women. Appl Physiol Nutr Metab. 2018 Dec;43(12):1247-1256. doi: 10.1139/apnm-2018-0113. Epub 2018 May 10.
Results Reference
result
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A Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults
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