Metabolic SyndromeNCT02774668
A Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults
A study testing "Grab-and-Go" meal plan and "Jump-Start" meal plan in people with Metabolic Syndrome, run by University of Missouri-Columbia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- "Grab-and-Go" meal plan and "Jump-Start" meal plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- 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).
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- "Grab-and-Go" meal plan, "Jump-Start" meal plan
- Keywords
- gender, arterial stiffness, blood pressure, weight loss, uric acid
- Medical subject headings
- Metabolic Syndrome, Coitus, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Grab-and-Go" meal planOther
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.
"Jump-Start" meal planOther
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.
| Study group | Role | What they receive |
|---|---|---|
| "Grab-and-Go" meal plan | Active comparator | 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. Receives: Other: "Grab-and-Go" meal plan |
| "Jump-Start" meal plan | Active comparator | 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. Receives: Other: "Jump-Start" meal plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change of body weight over 4 weeks of dietary intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: Questionnaires about food cravings will be administrated at baseline visit and 4 weeks after the start of the meal plan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Robert C. Atkins Foundation
- Responsible party
- Principal investigator, Elizabeth Jane Parks, University of Missouri-Columbia
- Investigators
- Qiong Hu, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774668
- Sponsor's protocol ID
- 2004733
- Status last verified
- Apr 2025
- First submitted
- 10 May 2016
- Last updated
- 4 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29746789
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT02774668
- Acronym / sponsor ID
- 2004733
- Conditions
- Metabolic Syndrome
- Keywords
- gender, arterial stiffness, blood pressure, weight loss, uric acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Robert C. Atkins Foundation
- Study start
- May 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Posted 30 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Grab-and-Go" meal plan | Active comparator | Other: "Grab-and-Go" meal planThe 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. |
| "Jump-Start" meal plan | Active comparator | Other: "Jump-Start" meal planThe 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. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Grab-and-Go" meal planThe "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. | Other | "Grab-and-Go" meal plan |
| "Jump-Start" meal planThe "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. | Other | "Jump-Start" meal plan |
Primary outcome
Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention
Time frame: 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.
3 secondary outcomes
Arterial Stiffness Changes Between Baseline and 4 Weeks
Time frame: Arterial stiffness will be measured at baseline and 4 weeks
Plasma Uric Acid Level Between Baseline and 4 Weeks.
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
Time frame: Questionnaires about food cravings will be administrated at baseline visit and 4 weeks after the start of the meal plan
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29746789Syed-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiong Hu, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Grab-and-Go" meal plan and "Jump-Start" meal plan in people with Metabolic Syndrome, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention (time frame: Change of body weight over 4 weeks of dietary intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02774668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.