ObesityVEGGIENCT02869659
Valued EpiGenetic Glycemic ImprovEments Through Weight Loss
A study testing Weight Loss Group and Delayed Weight Loss in people with Obesity and Pre-diabetes, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This randomized controlled clinical trial will use methylomic and transcriptomic profiling to examine the effects of a weight loss intervention on the cholesterol metabolism gene network in monocytes and adipocytes and investigate the longitudinal relationship between these modifications and glycemic improvements. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Obesity, Pre-diabetes
- What is being tested?
- Weight Loss Group and Delayed Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2016to 2 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI=30-45.0 kg/m2 OR BMI 27-30, if waist circumference is ≥ 40in in men or ≥ 35in in women
- Sedentary for past 6 mos (<20 min; 2 d/wk of resistance or aerobic exercise)
- Normal cognitive function:
- Greater than 12 years education:
- Caucasian - MOCA ≥ 24 African American/Hispanic/Other- MOCA ≥ 22
- 12 years or less education: Caucasian- MOCA ≥22 African American/Hispanic/Other- MOCA ≥20
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- No evidence of clinical depression
- Fasting blood glucose 100-125 mg/dl OR Hemoglobin A1c 5.7% - 6.4%
- No contraindications for participation in weight loss
- Able to provide own transportation to study visits and intervention
- Approved for participation by Medical Director
- Negative pregnancy test or confirmed post-menopausal/surgically sterile status (Women Only)
- Not involved in any other research study
- Willing to provide informed consent
Who cannot join
- Weight loss (±5%) in past 6 months
- Uncontrolled arrhythmias
- Cancer requiring treatment in past year, except non-melanoma skin cancers
- Regular smoker (>1 cigarette/day) or heavy drinker (>9 alcoholic drinks/wk) within past year
- Insulin dependent or uncontrolled diabetes (FBG>126 mg/dl) OR (Hemoglobin A1c 6.5% or greater)
- Uncontrolled hypertension (BP>160/90 mmHg)
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- Elevated triglyceride (TG>400 mg/dl)
- Clinically evident liver disease, kidney disease, edema or anemia
- Past or current ischemic heart disease, uncontrolled angina, heart failure, PAD, stroke, chronic respiratory disease, endocrine or metabolic disease, neurological or hematological disease
- Regular use growth/steroid hormones, including estrogen replacement, weight loss medications, diabetes medications including insulin and/or blood thinners
- History of any type of bariatric or weight loss surgery or bilateral oophorectomy requiring long term hormone replacement therapy use
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
This randomized controlled clinical trial will use methylomic and transcriptomic profiling to examine the effects of a weight loss intervention on the cholesterol metabolism gene network in monocytes and adipocytes and investigate the longitudinal relationship between these modifications and glycemic improvements.
Read the detailed description
The investigators plan to recruit a total of 200 middle-aged (40-65 years) obese (BMI=30-39.9 kg/m2), sedentary, pre-diabetic participants who will be randomized to either a 18-week dietary weight loss (n=100) followed by a 8-week transition and then 26 weeks of maintenance (Weight Loss group) or a delayed weight loss (Control group, n=100) intervention.
During the screening visit, eligible participants who provided informed consent will complete a 3-day food record and then start a 3-day run-in period using the Medifast® meal replacement products to be used for the weight loss intervention. At the next visit the participant will meet with the Registered Dietitian (RD) to undergo an assessment of Readiness to Change (18). All participants must be approved for eligibility by the RD based on her clinical judgment of likelihood of success for weight loss, likelihood of compliance to the Medifast® meal plan, and willingness to be randomized to either group.
Control/Delayed Weight Loss Group: (18 weeks) Participants randomized to the delayed weight loss intervention (n=100) will serve as a no-weight loss control to the weight loss group during the first 18 weeks of the study. During the control (18 weeks) phase these participants will receive a monthly phone call visit from staff to maintain contact and interest in the study. At the end of the initial 18 weeks participants will complete all follow up assessments prior to being offered the opportunity to participate in a weight loss program. This weight loss program will involve 18 weekly, group dietary and exercise sessions led by the study staff in which participants will follow a modified Diabetes Prevention Program. Participants will be given an individual introduction session to the weight loss program by study staff and will be guided by the RD on their food purchasing and preparation of their meals, but no meal replacements or supplements will be provided.
Weight Loss group: Phase 1 (18 weeks): Participants assigned to this group will undergo a dietary intervention for the first 18 weeks of the study designed to elicit an approximate 8-10% weight loss. The intervention will incorporate partial meal replacements, nutrition education, and some behavior modification.
This level of weight loss will be achieved through the combination of a partial meal replacement (MR) program and individual and group nutrition/behavioral counseling. Participants will be provided with and asked to consume 4 Medifast® MR per day. All participants will follow the Medifast Achieve TM 4 \& 2 \& 1 Plan® which includes the 4 MR products per day, with the addition of 2 Lean and Green™ Meals and 1 Healthy Snack. The Lean and Green™ Meals will be prepared by the participants and each will consist of 5-7 oz. lean protein, 3 servings of non-starchy vegetables and up to 2 servings of healthy fat. The Healthy Snack will consist of one serving of fruit, dairy, or grain. Each MR from Medifast® contains ~90-110 kcals and 10-15 g protein. Participants will be given an individual introduction on the meal plan prior to starting and will be guided by the RD on their food purchasing and preparation of the other Lean and Green TM meals. They are encouraged to consume only what is approved on the Medifast Achieve TM 4 \& 2 \& 1 Plan®.
Phase 2 (8 weeks): After completion of the active weight loss phase, participants in this group will attend bimonthly group meetings to discuss increasing their activity. The goal is for participants to slowly increase their activity to 150 minutes per week and then continue at 150 minutes per week to help them maintain their weight. Activity logs will be dispensed and topics such as tracking activity, finding time for fitness and getting active will be discussed.
Participants will have the option to transition off the meal replacements and potentially continue on a select few during the transition phase. Additional dietary guidance will be available to help participants transition off MR and maintain their weight. The RD will calculate individual maintenance calorie goals to be discuss with participants at a brief individual session prior to starting the transition phase. At this session an introduction to the transition phase and information on how to track their activity will also be discussed.
Phase 3 (26 weeks): After completion of phase 2, participants will be called monthly for 26 weeks and then asked to return for a maintenance visit at the end of the 52 weeks from study start. Participants will be offered an optional session with a staff member at the time of their exit to discuss long term goals and strategies and provide closure.
- Conditions
- Obesity, Pre-diabetes
- Being tested
- Weight Loss Group, Delayed Weight Loss
- Keywords
- obesity, pre-diabetes, overweight, lifestyle change, glucose
- Medical subject headings
- Obesity, Glucose Intolerance, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss GroupBehavioural
All participants will follow the Medifast Achieve TM 4 \& 2 \& 1 Plan® which includes the 4 MR products per day, with the addition of 2 Lean and Green™ Meals and 1 Healthy Snack
Delayed Weight LossBehavioural
18 weekly, group dietary and exercise sessions led by the study staff in which participants will follow a modified Diabetes Prevention Program
| Study group | Role | What they receive |
|---|---|---|
| Control/Delayed Weight Loss Group | Active comparator | Control/Delayed Weight Loss Group: (18 weeks) Participants randomized to the delayed weight loss intervention (n=100) will serve as a no-weight loss control to the weight loss group during the first 18 weeks of the study. During the control (18 weeks) phase these participants will receive a monthly phone call visit from staff to maintain contact and interest in the study. At the end of the initial 18 weeks participants will complete all follow up assessments prior to being offered the opportunity to participate in a weight loss program.
No outcome data will be collected at the end of the delayed weight loss phase. Receives: Behavioral: Delayed Weight Loss |
| Weight Loss Group | Experimental | Weight Loss group: Phase 1 (18 wks): Participants assigned to this group will undergo a dietary intervention for the first 18 weeks of the study.
This level of weight loss will be achieved through the combination of a partial meal replacement (MR) program and individual and group nutrition/behavioral counseling. Participants will be provided with and asked to consume 4 Medifast® MR per day.
Phase 2 (8 wks): After completion of the active weight loss phase, participants in this group will attend bimonthly group meetings to discuss increasing their activity.
Phase 3 (26 wks): After completion of phase 2, participants will be called monthly for 26 weeks and then asked to return for a maintenance visit at the end of the 52 weeks from study start. Receives: Behavioral: Weight Loss Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chang in Epigengene score (and related individual transcriptional and methylation measures)
The eigengene score is defined as the first principal component of a transcriptional network.
Measured: baseline and 18 weeks
Secondary outcomes (2)
change in glucose tolerance
A 2-hr OGTT will be performed to assess changes in glucose tolerance and insulin responses to the glucose challenge. Blood samples will be drawn before and after (30, 60, 90, and 120 min) a 75-g glucose ingestion for the determination of plasma glucose and insulin.
Measured: baseline and 18 weeks
change in homeostatic model assessment (HOMA) estimates of insulin resistance
A 2-hr OGTT will be performed to assess changes in glucose tolerance and insulin responses to the glucose challenge. Blood samples will be drawn before and after (30, 60, 90, and 120 min) a 75-g glucose ingestion for the determination of plasma glucose and insulin. An estimate of insulin sensitivity by the homeostasis model assessment (HOMA) score will be calculated with the formula: fasting plasma insulin (μU/ml) × glucose (mmol/l)/22.5 (25). Glucose and insulin areas will be determined using Tai's model(26): ½×30×(y0min+2y30min+2y60min+2y90min+y120min), where y represents insulin or glucose values at the different time points.
Measured: baseline and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start1 Nov 2016
- Primary completion29 Jul 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Medifast, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Jingzhong Ding, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869659
- Sponsor's protocol ID
- IRB00036970
- Other IDs
- R01DK103531
- Acronym
- VEGGIE
- Status last verified
- Dec 2020
- First submitted
- 25 Jul 2016
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mishra SP, Wang B, Jain S, Ding J, Rejeski J, Furdui CM, Kitzman DW, Taraphder S, Brechot C, Kumar A, Yadav H. A mechanism by which gut microbiota elevates permeability and inflammation in obese/diabetic mice and human gut. Gut. 2023 Oct;72(10):1848-1865. doi: 10.1136/gutjnl-2022-327365. Epub 2023 Mar 22.
PubMed 36948576
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valued EpiGenetic Glycemic ImprovEments Through Weight Loss
- ClinicalTrials.gov ID
- NCT02869659
- Acronym / sponsor ID
- VEGGIE / IRB00036970
- Conditions
- Obesity, Pre-diabetes
- Keywords
- obesity, pre-diabetes, overweight, lifestyle change, glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Medifast, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled clinical trial will use methylomic and transcriptomic profiling to examine the effects of a weight loss intervention on the cholesterol metabolism gene network in monocytes and adipocytes and investigate the longitudinal relationship between these modifications and glycemic improvements.
Detailed description
The investigators plan to recruit a total of 200 middle-aged (40-65 years) obese (BMI=30-39.9 kg/m2), sedentary, pre-diabetic participants who will be randomized to either a 18-week dietary weight loss (n=100) followed by a 8-week transition and then 26 weeks of maintenance (Weight Loss group) or a delayed weight loss (Control group, n=100) intervention.
During the screening visit, eligible participants who provided informed consent will complete a 3-day food record and then start a 3-day run-in period using the Medifast® meal replacement products to be used for the weight loss intervention. At the next visit the participant will meet with the Registered Dietitian (RD) to undergo an assessment of Readiness to Change (18). All participants must be approved for eligibility by the RD based on her clinical judgment of likelihood of success for weight loss, likelihood of compliance to the Medifast® meal plan, and willingness to be randomized to either group.
Control/Delayed Weight Loss Group: (18 weeks) Participants randomized to the delayed weight loss intervention (n=100) will serve as a no-weight loss control to the weight loss group during the first 18 weeks of the study. During the control (18 weeks) phase these participants will receive a monthly phone call visit from staff to maintain contact and interest in the study. At the end of the initial 18 weeks participants will complete all follow up assessments prior to being offered the opportunity to participate in a weight loss program. This weight loss program will involve 18 weekly, group dietary and exercise sessions led by the study staff in which participants will follow a modified Diabetes Prevention Program. Participants will be given an individual introduction session to the weight loss program by study staff and will be guided by the RD on their food purchasing and preparation of their meals, but no meal replacements or supplements will be provided.
Weight Loss group: Phase 1 (18 weeks): Participants assigned to this group will undergo a dietary intervention for the first 18 weeks of the study designed to elicit an approximate 8-10% weight loss. The intervention will incorporate partial meal replacements, nutrition education, and some behavior modification.
This level of weight loss will be achieved through the combination of a partial meal replacement (MR) program and individual and group nutrition/behavioral counseling. Participants will be provided with and asked to consume 4 Medifast® MR per day. All participants will follow the Medifast Achieve TM 4 \& 2 \& 1 Plan® which includes the 4 MR products per day, with the addition of 2 Lean and Green™ Meals and 1 Healthy Snack. The Lean and Green™ Meals will be prepared by the participants and each will consist of 5-7 oz. lean protein, 3 servings of non-starchy vegetables and up to 2 servings of healthy fat. The Healthy Snack will consist of one serving of fruit, dairy, or grain. Each MR from Medifast® contains ~90-110 kcals and 10-15 g protein. Participants will be given an individual introduction on the meal plan prior to starting and will be guided by the RD on their food purchasing and preparation of the other Lean and Green TM meals. They are encouraged to consume only what is approved on the Medifast Achieve TM 4 \& 2 \& 1 Plan®.
Phase 2 (8 weeks): After completion of the active weight loss phase, participants in this group will attend bimonthly group meetings to discuss increasing their activity. The goal is for participants to slowly increase their activity to 150 minutes per week and then continue at 150 minutes per week to help them maintain their weight. Activity logs will be dispensed and topics such as tracking activity, finding time for fitness and getting active will be discussed.
Participants will have the option to transition off the meal replacements and potentially continue on a select few during the transition phase. Additional dietary guidance will be available to help participants transition off MR and maintain their weight. The RD will calculate individual maintenance calorie goals to be discuss with participants at a brief individual session prior to starting the transition phase. At this session an introduction to the transition phase and information on how to track their activity will also be discussed.
Phase 3 (26 weeks): After completion of phase 2, participants will be called monthly for 26 weeks and then asked to return for a maintenance visit at the end of the 52 weeks from study start. Participants will be offered an optional session with a staff member at the time of their exit to discuss long term goals and strategies and provide closure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control/Delayed Weight Loss Group | Active comparator | Behavioral: Delayed Weight LossControl/Delayed Weight Loss Group: (18 weeks) Participants randomized to the delayed weight loss intervention (n=100) will serve as a no-weight loss control to the weight loss group during the first 18 weeks of the study. During the control (18 weeks) phase these participants will receive a monthly phone call visit from staff to maintain contact and interest in the study. At the end of the initial 18 weeks participants will complete all follow up assessments prior to being offered the opportunity to participate in a weight loss program. No outcome data will be collected at the end of the delayed weight loss phase. |
| Weight Loss Group | Experimental | Behavioral: Weight Loss GroupWeight Loss group: Phase 1 (18 wks): Participants assigned to this group will undergo a dietary intervention for the first 18 weeks of the study. This level of weight loss will be achieved through the combination of a partial meal replacement (MR) program and individual and group nutrition/behavioral counseling. Participants will be provided with and asked to consume 4 Medifast® MR per day. Phase 2 (8 wks): After completion of the active weight loss phase, participants in this group will attend bimonthly group meetings to discuss increasing their activity. Phase 3 (26 wks): After completion of phase 2, participants will be called monthly for 26 weeks and then asked to return for a maintenance visit at the end of the 52 weeks from study start. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- BMI=30-45.0 kg/m2 OR BMI 27-30, if waist circumference is ≥ 40in in men or ≥ 35in in women
- Sedentary for past 6 mos (<20 min; 2 d/wk of resistance or aerobic exercise)
- Normal cognitive function:
- Caucasian - MOCA ≥ 24 African American/Hispanic/Other- MOCA ≥ 22
- 12 years or less education: Caucasian- MOCA ≥22 African American/Hispanic/Other- MOCA ≥20
Key exclusion criteria (11 listed)
- Weight loss (±5%) in past 6 months
- Uncontrolled arrhythmias
- Cancer requiring treatment in past year, except non-melanoma skin cancers
- Regular smoker (>1 cigarette/day) or heavy drinker (>9 alcoholic drinks/wk) within past year
- Insulin dependent or uncontrolled diabetes (FBG>126 mg/dl) OR (Hemoglobin A1c 6.5% or greater)
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 |
|---|---|---|
| Weight Loss GroupAll participants will follow the Medifast Achieve TM 4 \& 2 \& 1 Plan® which includes the 4 MR products per day, with the addition of 2 Lean and Green™ Meals and 1 Healthy Snack | Behavioural | Weight Loss Group |
| Delayed Weight Loss18 weekly, group dietary and exercise sessions led by the study staff in which participants will follow a modified Diabetes Prevention Program | Behavioural | Control/Delayed Weight Loss Group |
Primary outcome
Chang in Epigengene score (and related individual transcriptional and methylation measures)
Time frame: baseline and 18 weeks
The eigengene score is defined as the first principal component of a transcriptional network.
2 secondary outcomes
change in glucose tolerance
Time frame: baseline and 18 weeks
change in homeostatic model assessment (HOMA) estimates of insulin resistance
Time frame: baseline and 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Derived from this study: PubMed 36948576Mishra SP, Wang B, Jain S, Ding J, Rejeski J, Furdui CM, Kitzman DW, Taraphder S, Brechot C, Kumar A, Yadav H. A mechanism by which gut microbiota elevates permeability and inflammation in obese/diabetic mice and human gut. Gut. 2023 Oct;72(10):1848-1865. doi: 10.1136/gutjnl-2022-327365. Epub 2023 Mar 22.
- 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.
Jingzhong Ding, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss Group and Delayed Weight Loss in people with Obesity and Pre-diabetes, run by Wake Forest University Health Sciences 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 14 inclusion and 11 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 31 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Chang in Epigengene score (and related individual transcriptional and methylation measures) (time frame: baseline and 18 weeks). 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 NCT02869659, 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 31 Dec 2020.