Precision Nutrition Impact on Health-Related Behavior Change

Metabolic Syndrome Clinical Trial

Official title:

Precision Nutrition Impact on Health-Related Behavior Change in Active Duty Service Members

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04959318
• Other study ID #: 219081
• Status: Completed
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: July 9, 2021

Study information

• Verified date: January 2024
• Source: Madigan Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, randomized, controlled trial enrolling up to 150 service members (SMs) from two sites; Joint Base Lewis McChord (JBLM) in the Northwest and Joint Base San Antonio (JBSA)-Lackland in the Southwest. A baseline genomic profile (70 genes/80 single nucleotide polymorphisms [SNPs]) augmented by common serum biomarkers specific to diet-related chronic disease (metabolic syndrome, cardiovascular disease [CVD], vitamin D deficiency) risk will be created. Subjects will be randomized to either personalized nutrition counseling or standard nutrition education for 6 weeks. This interval matches Service-run healthy weight initiatives such as the Army's current Fit for Performance Program. To promote self-care and engagement, a digital app will be utilized for 2 weeks for real-time health data capture with continuous feedback and will be validated with in-person RD interviews. Physical activity and injury data, sun exposure, and family history will help elucidate unique individual responses. Participant follow-up at 12 weeks will evaluate changes in anthropometrics and metabolic, cardiovascular, and vitamin D biomarkers.

Description:

Precision nutrition leverages the specificity of molecular and phenotypic differences in personalizing diet and lifestyle interventions. Specific Aims: 1) Examine the effectiveness of gene-based nutrition counseling on health-related behavior change in service members as measured by body weight, body mass index (BMI), blood glucose, lipids, 25-hydroxyvitamin (OH) D, %body fat (BF), waist circumference, and blood pressure; 2) Evaluate the feasibility of a digital application to accurately capture diet, activity, and sleep behaviors; and 3) Describe military-unique characteristics in demographics, diet, and lifestyle for northwest Army and southwest Air Force cohorts.

A baseline genomic profile will be created from 70 diet-responsive genes and 80 variants following amplicon sequencing on an Illumina MiSeq platform and will be informed by serum biomarkers specific to diet-related chronic disease risk (i.e. metabolic syndrome, vitamin D deficiency) for each subject. Risk variants were selected if minor allele frequency > 5% and at least two published papers verified the link to the phenotype of interest. Treatment group receives gene-based nutrition counseling for six weekly sessions; Controls receive evidence-based nutrition pamphlets, all content directed at preventing metabolic syndrome. A digital app provides real-time health data capture with continuous feedback and is verified by in-person dietitian interviews. Both groups will also use study resources independently for six weeks, returning for final body composition and serum biomarkers after the twelve-week intervention. The control group receives the genomic profile with dietary recommendations upon study completion. Data analysis will examine between-group and by-cohort differences on primary anthropometric and biomarker outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: July 9, 2021
• Est. primary completion date: July 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Active duty Army or Air Force

• Age 18-45

• Able to read and comprehend English

• Assigned to JBLM or JBSA-Lackland,

• Remaining on station for 5 months

• Consider self generally healthy

• History of or currently out of compliance with military fitness standards

• Willing to submit 2 blood samples including one for gene testing

• Willing to undergo 1 DEXA scan (JBLM only)

• Willing to participate in 6 weekly nutrition counseling sessions if assigned to treatment group

Exclusion Criteria:

• Currently diagnosed with an eating disorder

• Pregnant

• Current physical training profile (ie limitation)

• Pending deployment in next 5 months

• Pending retirement in next 5 months

• Pending permanent change of duty station in the next 5 months

• Currently has a pacemaker (contraindicated for bioelectrical impedance analysis)

Related Conditions & MeSH terms

• Metabolic Syndrome

Intervention

Other:
• Professional nutrition counseling
Published multi-cohort genome-wide association studies provided genes and genetic variants that are credibly associated with aspects of metabolic syndrome (MetS), CVD, overweight/obesity, and vitamin D metabolism. Registered dietitian (RD) counseling will review potentially harmful and protective variants for risk of MetS with subjects and make evidence-based recommendations to improve diet quality and achieve weight loss goals. Each of the 6 weekly sessions covered a specific component of MetS. Counseling will take place once a week either in-person or via phone/virtual platform based on preference and availability of the subject. Counselors will review digital app data entries for food intake prior to this interaction for the first 2 weeks.
• No professional nutrition counseling
Participants receive pamphlets with evidence-based general health, healthy nutrition, exercise and sleep content. They receive information on genetic variants related to MetS at end of study period.

Locations

Country	Name	City	State
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Madigan Army Medical Center	TriService Nursing Research Program

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bray MS, Loos RJ, McCaffery JM, Ling C, Franks PW, Weinstock GM, Snyder MP, Vassy JL, Agurs-Collins T; Conference Working Group. NIH working group report-using genomic information to guide weight management: From universal to precision treatment. Obesity (Silver Spring). 2016 Jan;24(1):14-22. doi: 10.1002/oby.21381. Erratum In: Obesity (Silver Spring). 2016 Mar;24(3):757. — View Citation

Celis-Morales C, Livingstone KM, Marsaux CF, Forster H, O'Donovan CB, Woolhead C, Macready AL, Fallaize R, Navas-Carretero S, San-Cristobal R, Kolossa S, Hartwig K, Tsirigoti L, Lambrinou CP, Moschonis G, Godlewska M, Surwillo A, Grimaldi K, Bouwman J, Daly EJ, Akujobi V, O'Riordan R, Hoonhout J, Claassen A, Hoeller U, Gundersen TE, Kaland SE, Matthews JN, Manios Y, Traczyk I, Drevon CA, Gibney ER, Brennan L, Walsh MC, Lovegrove JA, Alfredo Martinez J, Saris WH, Daniel H, Gibney M, Mathers JC. Design and baseline characteristics of the Food4Me study: a web-based randomised controlled trial of personalised nutrition in seven European countries. Genes Nutr. 2015 Jan;10(1):450. doi: 10.1007/s12263-014-0450-2. Epub 2014 Dec 10. — View Citation

Corella D, Coltell O, Mattingley G, Sorli JV, Ordovas JM. Utilizing nutritional genomics to tailor diets for the prevention of cardiovascular disease: a guide for upcoming studies and implementations. Expert Rev Mol Diagn. 2017 May;17(5):495-513. doi: 10.1080/14737159.2017.1311208. Epub 2017 Apr 3. — View Citation

de Toro-Martin J, Arsenault BJ, Despres JP, Vohl MC. Precision Nutrition: A Review of Personalized Nutritional Approaches for the Prevention and Management of Metabolic Syndrome. Nutrients. 2017 Aug 22;9(8):913. doi: 10.3390/nu9080913. — View Citation

Joseph MS, Konerman MA, Zhang M, Wei B, Brinza E, Walden P, Jackson EA, Rubenfire M. Long-term outcomes following completion of a structured nutrition and exercise lifestyle intervention program for patients with metabolic syndrome. Diabetes Metab Syndr O — View Citation

Liang Y, Kelemen A. Shared polymorphisms and modifiable behavior factors for myocardial infarction and high cholesterol in a retrospective population study. Medicine (Baltimore). 2017 Sep;96(37):e7683. doi: 10.1097/MD.0000000000007683. — View Citation

Locke AE, Kahali B, Berndt SI, Justice AE, Pers TH, Day FR, Powell C, Vedantam S, Buchkovich ML, Yang J, Croteau-Chonka DC, Esko T, Fall T, Ferreira T, Gustafsson S, Kutalik Z, Luan J, Magi R, Randall JC, Winkler TW, Wood AR, Workalemahu T, Faul JD, Smith — View Citation

Povel CM, Boer JM, Onland-Moret NC, Dolle ME, Feskens EJ, van der Schouw YT. Single nucleotide polymorphisms (SNPs) involved in insulin resistance, weight regulation, lipid metabolism and inflammation in relation to metabolic syndrome: an epidemiological study. Cardiovasc Diabetol. 2012 Oct 29;11:133. doi: 10.1186/1475-2840-11-133. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Pounds lost between measurements	12-14 weeks
Secondary	Body fat	Percent change in body fat over time	12-14 weeks
Secondary	Waist circumference	Change in waist circumference measured in inches to reduce risk for MetS over time	12-14 weeks
Secondary	Serum Cholesterol	Blood level of serum cholesterol to reduce risk for MetS over time	12-14 weeks
Secondary	Systolic blood pressure	Change in systolic blood pressure to reduce risk for MetS over time	12-14 weeks
Secondary	Diastolic blood pressure	Change in diastolic blood pressure to reduce risk for MetS over time	12-14 weeks
Secondary	Serum glucose	Change in blood glucose level to reduce risk for MetS over time	12-14 weeks
Secondary	Serum triglyceride	Change in blood triglyceride level to reduce risk for MetS over time	12 -14 weeks