(P13-032-25) Body Weight Changes During a Randomized Clinical Trial Involving Isocaloric Substitution of Low-Fat or Full-Fat Fermented Dairy or Non-Dairy Foods Into the Usual Diet

Objectives: This sub-study will assess changes in body weight as well as dietary intake in participants undergoing an intervention that substitutes two servings of either low-fat fermented dairy, full-fat fermented dairy, or non-dairy control foods for foods of similar calories and macronutrient composition within their usual diet.

Methods: The parent study was a randomized, controlled, parallel-arm clinical trial evaluating the impact of full-fat or low-fat fermented dairy on insulin sensitivity, and other cardiometabolic health markers in adults with elevated blood triglycerides. Participants were randomized to one of three groups: full-fat fermented dairy, low-fat fermented dairy, or non-dairy (control). The current sub-study will evaluate changes in participants’ weight and dietary intake (i.e., calories, macro-, and micro-nutrients) during the study period (i.e., baseline, weeks 4, 8, and 12) by analyzing anthropometric data and nutrient intake data from 3-day diet records collected within the parent study. An interim analysis was done using R version 4.3.1. Generalized estimating equations (GEE) modeling was used to estimate population-averaged effects, focusing on overall trends across the population, accounting for within-individual correlation occurring in repeated measures.

Results: The parent study will be completed in January 2025. We expect to analyze data from 18 participants; an interim analysis of data from 4 participants is presented here. The participants were 47.8±15.3 years, had a body mass index of 32.5 ± 4.4 kg/m², and were 75% female, and 100% White. During the intervention, higher changes in body weight from baseline were predicted by higher energy intake (β estimate = 0.03, standard error = 0.01, P = 0.002). Females had lower body weight compared to males (β estimate = -33.75, standard error = 10.79, P = 0.002). Only 1 of the 4 participants changed body weight by > 5% from baseline. Changes in dietary intake of macronutrients were not associated with changes in body weight (P > 0.05).

Conclusions: The interim analysis for an ongoing clinical trial will provide information on weight stability and correlates of weight changes among study participants.

Funding Sources: National Dairy Council