mNDPR Diet for Obesity

Overseen By Nanette Lopez, PhD, MS/MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northern Arizona University

Must not be taking: Insulin

Disqualifiers: Weight loss surgeries, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 38

Duration: 12 weeks

146 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that could increase medical risk or have weight loss as a primary side effect.

What data supports the effectiveness of the mNDPR diet treatment for obesity?

Research suggests that addressing micronutrient deficiencies, which are common in obese individuals, can help manage obesity. Studies show that inadequate intake of certain vitamins and minerals is linked to higher body mass index (BMI) and waist circumference, indicating that a micronutrient-dense diet may be beneficial for weight management. ^{1 2 3 4 5}

Is the mNDPR Diet for Obesity safe for humans?

The safety of the mNDPR Diet, which focuses on a micronutrient-dense, plant-rich approach, is generally supported by research showing that diets rich in whole grains, vegetables, and fruits are associated with better health outcomes. However, ensuring adequate intake of certain nutrients like vitamin D, calcium, iron, and zinc is important, as these can sometimes be low in plant-rich diets. ^{4 6 7 8 9}

How is the mNDPR diet treatment for obesity different from other treatments?

The mNDPR diet is unique because it focuses on providing a high intake of essential micronutrients through a plant-rich diet, which may help address common micronutrient deficiencies in obese individuals that are not typically targeted by other treatments. This approach aims to improve overall nutrition and potentially reduce obesity-related health issues by ensuring adequate levels of vitamins and minerals. ^{1 3 4 10 11}

What is the purpose of this trial?

The investigators propose to conduct a randomized controlled trial with a wait-list control to determine efficacy in reducing risk of obesity and related disease in Native American employees of Twin Arrows Casino. Participants will be randomly assigned to the experimental group or the wait-list control. The experimental group will receive a 12-week mNDPR nutrition intervention with culturally relevant materials. Five NAU Masters of Public Health (MPH) students will be trained in Motivational Interviewing and the mNDPR nutrition protocol to serve as Lifestyle Coaches. These students will lead weekly, group-based coaching sessions with up to 15 participants each at Twin Arrows Casino. Participants will be assigned to their designated group based on their availability. The 12 weekly group sessions will be scheduled to accommodate various work shifts (day, night, and swing). The first group session will be 2-hours long to serve as an 'immersion', followed by weekly 1-hour sessions, all led by the Lifestyle Coaches. The Lifestyle Coaches will use Motivational Interviewing techniques to assist participants to develop personal goals. Lifestyle Coaches will also provide nutrition education, specifically using the mNDPR protocol. Participants in the wait-list control will receive the same intervention after the experimental group completes their 12-week intervention. In addition to measures at weeks 0 and 13, a 24-hour diet recall will be conducted in week 26 for the experimental group to explore long-term durability of diet quality changes.

Research Team

Nanette Lopez, PhD, MS/MS

Principal Investigator

Northern Arizona University

Eligibility Criteria

This trial is for self-identified Native American employees of Twin Arrows Casino, aged 21-65 with a BMI over 24, not on weight-loss programs or certain medications. They must have worked there for at least a year and plan to stay another year but can't join if pregnant, planning pregnancy, had specific weight loss surgeries, or cannot attend weekly sessions.

Inclusion Criteria

I am between 21 and 65 years old.

I have worked at Navajo Gaming Enterprise for a year and plan to continue working there during the study.

Self-identified Native American employee of Twin Arrows Casino

Exclusion Criteria

I have had weight loss surgery, such as gastric bypass or sleeve.

I rely on insulin for my diabetes management.

I can attend weekly group coaching sessions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week mNDPR nutrition intervention with weekly group-based coaching sessions

12 weeks

12 weekly group sessions (in-person)

Follow-up

Participants are monitored for long-term durability of diet quality changes and health measures

26 weeks

Diet recall at week 26, health measures at weeks 13 and 26

Long-term Follow-up

Healthcare utilization data collected to evaluate cost-effectiveness

52 weeks

Treatment Details

Interventions

• Micronutrient-dense plant-rich Intervention

Trial Overview The study tests a culturally-tailored diet intervention aimed at reducing obesity risk among participants. It involves random assignment to either an immediate or wait-list group receiving the mNDPR nutrition protocol through weekly coaching sessions by trained students using Motivational Interviewing techniques.

Participant Groups

Group I: Micronutrient-dense plant-rich Intervention Experimental Treatment 1 Intervention

The intervention will consist of a 2-hour 'immersion' group session, followed by weekly 1-hour group sessions over the following 11 weeks. Groups of no more than 15 individuals will meet weekly for 12 weeks with a trained Lifestyle Coach. Group sessions, held at the Twin Arrows Casino, will provide participants with instructions, assistance with goal setting, support, encouragement, cooking demonstrations, Casino (workplace) dining tours, and will socially engage with other participants. Participants will be requested to follow the mNDPR nutrition protocol for the first 12 weeks. Each week the participants will use a simple tracking method to self-monitor their daily compliance with the nutrition protocol. Lifestyle Coaches will monitor adherence and verify attendance. Instructional materials discussed each week will provide resources and methods to overcome common barriers to dietary change including (i) meal prepping, (ii) social gatherings, and (iii) family resistance.

Group II: Wait-list Control Active Control 1 Intervention

Participants in the wait-list control group will be requested to maintain their typical eating patterns during a 12-week waiting period, until they are scheduled to start the intervention 13-weeks later.

Who Is Running the Clinical Trial?

Northern Arizona University

Lead Sponsor

Trials

36

Recruited

6,300+

Findings from Research

Micronutrition, particularly through a Mediterranean diet, is proposed as an effective strategy to address micronutrient deficiencies commonly found in obese individuals, emphasizing the importance of personalized dietary supplementation.

Identifying micronutritional deficits, such as those in iron, chromium, and essential fatty acids, is crucial for the management of obesity, as these factors can significantly impact health and weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Micronutrition: a global approach for obese patients]. Chos, D., Badel, S., Golay, A.[2015]

A network meta-analysis of 36 randomized controlled trials showed that various dietary interventions (HFLC, LFHC, and MM diets) led to significant weight loss compared to a usual diet over a period of 12 months.

The high fat/low carbohydrate (HFLC) diet resulted in slightly greater weight loss and reduction in BMI compared to moderate macronutrient (MM) diets, although all diets were effective in reducing waist circumference without significant differences among them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long Term Weight Loss Diets and Obesity Indices: Results of a Network Meta-Analysis. Jabbour, J., Rihawi, Y., Khamis, AM., et al.[2022]

In a study of 1,222 adults in Southern Brazil, many participants had inadequate intake of essential micronutrients like calcium and vitamins A, C, D, and E, which was linked to higher rates of general and abdominal obesity.

Specifically, lower consumption of calcium and iron was associated with increased body mass index (BMI) and waist circumference (WC), indicating that improving micronutrient intake may help in managing obesity, particularly in younger adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Relationship between dietary consumption of vitamins and minerals, body mass index, and waist circumference: a population-based study of adults in southern Brazil]. Cembranel, F., Hallal, ALC., González-Chica, DA., et al.[2018]

Obese individuals often have a diet that is high in calories but low in essential micronutrients, leading to deficiencies in important vitamins and minerals such as vitamin D, vitamin C, and iron.

A three-month low-calorie formula diet designed to meet dietary reference intakes (DRI) did not improve micronutrient levels in obese subjects; in fact, some deficiencies worsened, suggesting that standard DRI may not adequately address the unique nutritional needs of obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Micronutrient deficiency in obese subjects undergoing low calorie diet. Damms-Machado, A., Weser, G., Bischoff, SC.[2022]

In a study of 77 severely obese patients awaiting bariatric surgery, while their macronutrient intake was generally adequate, significant micronutrient deficiencies were identified, particularly in potassium (19.5% adequate), calcium (26.0% adequate), and iron (66.2% adequate).

The findings suggest that despite high calorie consumption, the diet of these patients is unbalanced, indicating a need for qualitative dietary changes alongside caloric restriction to address these micronutrient deficiencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity coexists with malnutrition? Adequacy of food consumption by severely obese patients to dietary reference intake recommendations. Correia Horvath, JD., Dias de Castro, ML., Kops, N., et al.[2016]

Men following a fat-modified diet in the Multiple Risk Factor Intervention Trial generally maintained adequate intake of most vitamins and minerals, with mean intakes of 15 micronutrients above recommended dietary allowances, although zinc and calcium were slightly below at 77% and 79% of the recommended levels, respectively.

The dietary intervention was deemed safe, as those who adhered closely to the program showed improved micronutrient profiles, evidenced by reductions in serum cholesterol and weight loss, suggesting that the eating pattern did not compromise nutritional adequacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional adequacy of diets reported at baseline and during trial years 1-6 by the special intervention and usual care groups in the Multiple Risk Factor Intervention Trial. Dolecek, TA., Johnson, RL., Grandits, GA., et al.[2018]

In a study of 53 overweight and obese adults, calcium plus vitamin D3 supplementation during a 12-week energy-restricted diet led to significantly greater fat mass loss compared to an energy-restricted diet alone, with a decrease of 2.8 kg versus 1.8 kg in fat mass.

The supplementation also resulted in a greater reduction in visceral fat mass and area, indicating potential benefits for metabolic health, although no significant changes were observed in overall body weight or metabolic variables.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium plus vitamin D3 supplementation facilitated fat loss in overweight and obese college students with very-low calcium consumption: a randomized controlled trial. Zhu, W., Cai, D., Wang, Y., et al.[2022]

A review of 167 studies found that certain diets, like the Mediterranean and DASH diets, can effectively reduce obesity risk in individuals with specific genetic predispositions, particularly those carrying risk alleles for obesity-related SNPs like FTO.

There is a significant gap in research on gene-diet interactions related to undernutrition and micronutrient status, indicating a need for more studies in these areas to better understand personalized nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In the context of the triple burden of malnutrition: A systematic review of gene-diet interactions and nutritional status. Tan, PY., Moore, JB., Bai, L., et al.[2022]

Analysis of four popular diet plans revealed that none provided sufficient levels of all 27 essential micronutrients according to FDA guidelines, with an average of only 11.75 micronutrients meeting the recommended daily intake.

To achieve sufficiency for all 27 micronutrients, an impractical average calorie intake of 27,575 calories would be necessary, highlighting a significant risk of micronutrient deficiency for individuals following these diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of micronutrient deficiency in popular diet plans. Calton, JB.[2021]

In a study of 463 childbearing-age women at risk for insulin resistance (IR), only 56-65% met the Dietary Reference Intake (DRI) for certain micronutrients like vitamin B12 and vitamin C, while many failed to meet the DRI for others, such as folate and vitamins A, D, and E.

Women who met the DRIs for folate and vitamin C while maintaining acceptable calorie intake were significantly less likely to exhibit higher insulin resistance, suggesting that adequate micronutrient intake is crucial for preventing IR in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The consumption of micronutrients in relation to calorie intake and risk of insulin resistance. Piyathilake, CJ., Badiga, S., Hernandez, A., et al.[2023]

Obesity is linked to lower levels of specific antioxidants, such as carotenoids, vitamins E and C, zinc, magnesium, and selenium, which may contribute to obesity-related diseases like cardiovascular disease.

A review of 31 studies found that these antioxidants are inversely correlated with obesity and body fat mass, but inconsistencies in findings suggest that further intervention studies are needed to determine if these associations are causal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Antioxidant Intake/Status and Obesity: a Systematic Review of Observational Studies. Hosseini, B., Saedisomeolia, A., Allman-Farinelli, M.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Micronutrition: a global approach for obese patients]. [2015]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Long Term Weight Loss Diets and Obesity Indices: Results of a Network Meta-Analysis. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

[Relationship between dietary consumption of vitamins and minerals, body mass index, and waist circumference: a population-based study of adults in southern Brazil]. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Micronutrient deficiency in obese subjects undergoing low calorie diet. [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

Obesity coexists with malnutrition? Adequacy of food consumption by severely obese patients to dietary reference intake recommendations. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Nutritional adequacy of diets reported at baseline and during trial years 1-6 by the special intervention and usual care groups in the Multiple Risk Factor Intervention Trial. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Calcium plus vitamin D3 supplementation facilitated fat loss in overweight and obese college students with very-low calcium consumption: a randomized controlled trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

In the context of the triple burden of malnutrition: A systematic review of gene-diet interactions and nutritional status. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Prevalence of micronutrient deficiency in popular diet plans. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The consumption of micronutrients in relation to calorie intake and risk of insulin resistance. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Association Between Antioxidant Intake/Status and Obesity: a Systematic Review of Observational Studies. [2018]